Mild Cognitive ImpairmentAPT-IINCT04606953
Working Memory Training in Older Adults With Mild Cognitive Impairment : Impacts on Cognition and Ecological Activities
A study testing Attention Process Training (APT-II) in people with Mild Cognitive Impairment and Alzheimer Disease, run by University of Paris 5 - Rene Descartes at 1 site in France.
Trial summary
Older adults with Mild Cognitive Impairment (MCI) have an increased risk of developing dementia but do not meet the criteria for dementia. Cognitive rehabilitation makes it possible to compensate, at least in part, for cognitive deficits with the ultimate goal of reducing their impact in everyday life. Read more about this study
- Who is it for?
- Ages 55 years and older
- Conditions the study is for
- Mild Cognitive Impairment, Alzheimer Disease
- What is being tested?
- Attention Process Training (APT-II)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteFrance
- Study dates
- 1 Feb 2019to 27 Sep 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- MCI criteria according to Petersen 2004
- 55 years and over
- Native French-speaking or bilingual participant living in the Paris region
- Normal or corrected vision and hearing
- Presence of episodic memory and/or attention and/or working memory impairment as evidenced by substandard performance on neuropsychological test(s) evaluating these processes (-1.5 deviations from the norms)
Who cannot join
- Presence of dementia
- Significant impact of cognitive impairment on activities of daily living requiring external assistance or institutionalization
- Stroke or brain injury
- Presence of moderate to severe psychiatric disorders
- Ethylism
- General anesthesia in the last six months
- Treatment directly impacting cognition
- Patient with significant depression (cut off GDS > 10)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Working Memory Training With Attention Process Training (APT-II) in Older Adults With Mild Cognitive Impairment : Impacts on Cognition and Ecological Activities
Older adults with Mild Cognitive Impairment (MCI) have an increased risk of developing dementia but do not meet the criteria for dementia. Cognitive rehabilitation makes it possible to compensate, at least in part, for cognitive deficits with the ultimate goal of reducing their impact in everyday life. The objective of the research is to evaluate the short- and long-term effectiveness and generalization of an attention and working memory training program (APT-II) on cognition and ecological activities in MCI patients with a randomized controlled trial. Thirty MCI patients will be randomly assigned between a "cognitive training with APT-II" condition and a control (routine care) condition. The intervention will consist of an 8-week individual cognitive training program (2 sessions/week), training different attentional components and working memory. This has the advantage of insisting on the transfer of the acquired knowledge in sessions to daily activities. To evaluate the effectiveness of the treatment, cognitive and functional follow-up measures (including a virtual reality task) are administered at several time intervals. This project should contribute to better management of cognitive disorders by offering a new standardized rehabilitation tool in French to clinical practice.
Read the detailed description
Older adults with Mild Cognitive Impairment (MCI) have an increased risk of developing dementia, but do not meet the criteria for dementia. Some of these individuals nevertheless remain in a stable state or even return to the norm. Currently, pharmacological treatments have not been shown to be sufficiently effective in treating cognitive deficits. The major challenge is to identify other therapeutic approaches to reduce the risk of cognitive impairment progressing to dementia. Deficits in working memory, which are very common in these individuals, have a prognostic value for progression to dementia of the Alzheimer's type. Cognitive re-education makes it possible to compensate, at least in part, for cognitive disorders with the ultimate goal of reducing their repercussions in daily life. Executive control training can improve working memory and attention, but how this gain is transferred to activities of daily living (ADLs) remains poorly understood to date. The generalization of cognitive gains to ADLs is crucial, however, as this generalization may contribute to patients' functional autonomy.
This project aims to evaluate the effectiveness of attention and working memory training (APT-II) on cognitive function and ecological activities in MCI patients by means of a single-blind randomized controlled trial. Working memory is involved in information manipulation and attentional processes. This ability is called upon in higher cognitive functions such as language, reasoning, comprehension, but also in various complex ADL situations. Deficits in working memory thus contribute significantly to other cognitive or functional impairments in MCI patients. To date, some working memory training has been shown to have an immediate impact on working memory in this population. However, long-term maintenance and impact on daily life have not been demonstrated in this population. Researchers of this study propose to fill this gap by using the APT-II (or Attention Process Training) program, which focuses on the transfer of cognitive gains from the start of training. Indeed, the APT-II program was translated from English to French by the scientific coordinator (S. Blanchet). The English version has already been validated in various populations with mild cognitive dysfunction following brain injury, stroke or small vessel brain disease. The efficacy of APT-II has never been studied in older adults with IBD. For the first time a research team evaluate the short- and long-term efficacy of this program in MCI patients on cognition and ADLs using virtual reality. This new technology provides an ecological and objective measure for the evaluation of memory and other cognitive functions while simulating naturalistic and controlled situations. The objective is therefore to evaluate the effectiveness of an attention and working memory training program (APT-II) on cognitive function in patients with MCI. To achieve this objective, patients with MCI are randomly assigned to an APT-II program or to a control group. Cognitive training with the APT-II program will include progressively more difficult and adaptive exercises and will be varied to facilitate near and far cognitive transfer. Attention, working memory and episodic memory are measured at different time intervals (before, immediately after, 3 and 6 months after training). A unique feature of the cognitive training program is its emphasis on generalization by teaching participants how to maximize the transfer of the attention management strategies learned during the sessions to their various ADLs requiring attention and executive control. Homework exercises targeting these different cognitive functions in ADLs are also provided between sessions.
The protocol is offered to elderly people with mild cognitive impairment. In this single-blind randomized controlled trial, participants are randomly assigned either to a "cognitive training" experimental group (n=20) or a "standard care" control group (n=20). Recruitment is multi-centric, and takes place via memory consultations from several sites: Tenon Hospital (collaboration with Dr Eric Bouvard), AP-HP Sorbonne University, and Dr Mettling's private neurology practice (Paris XI). MCI patients are selected according to the criteria of Petersen (2004). A battery of standardized neuropsychological tests is first administered to ensure that participants meet our criteria. Patients must be at least 55 years of age and have an impairment of attention, exécutive, memory and/or working memory as evidenced by impaired performance on tests assessing attention or executive function (score 1.5 standard deviation below the norm on these tests). Participants meeting the selection criteria are invited to continue the study. The project has already been approved by the Committee for the Protection of Persons (CPP) EST-III of the ANSM (BCR ID: 2018-A02377-48, N°CPP: 18.11.05, N° 18.08.21.66617). Patients in the experimental group receive the APT-II training program individually with a psychologist for 8 weeks (2 sessions/week). The exercises target different attentional components and working memory in the auditory-visual modalities. This exercices are of increasing difficulty while being adapted to each patient's profile in order to maximize the effects on cognitive reserve. During the sessions, the emphasis is on generalizing the gains towards the most problematic daily activities in order to reduce the impact of the patients' cognitive problems in their daily lives. Patients in the control group receive standard routine care. In order to test the impact of the APT-II training program on cognitive function and daily activities, cognitive and functional follow-up measures are administered in a blind condition just before (T0), after (T1), and 3 (T2) and 6 months (T3) after the intervention. The last two measures will be used to study long-term maintenance of earnings. The cognitive follow-up measures will test the effects of near (attention, working memory) and far (episodic memory) cognitive transfers and generalization to daily activities with questionnaires. Functional follow-up measures include a virtual reality task assessing episodic memory in the presence of interferences in order to examine the effects of training on an ecological situation with high demands on attentional resources.
MCI patients who received the APT-II training program should perform better on attention and working memory tasks after training, with a distant transfer to episodic memory tasks compared to the control group who received standard care during the training time interval. Following cognitive training, MCI patients should also be less susceptible to environmental interferences as assessed with the virtual reality task, while reporting fewer cognitive complaints in everyday life with maintenance of these gains over time. In patients in the control group, it is anticipated that there will be no difference in follow-up measures between the different times or the presence of decreased performance as these patients are at risk of developing neurodegenerative pathology. In a preliminary study evaluating the efficacy of the APT-II programme by the same team of research, six MCI patients (m = 68 ± 10.56 years) attended 10 sessions of the APT-II programme (2 sessions/week). Statistical analyses indicate that after cognitive training, MCI patients tended to improve their performance on a working memory task (upside down number span, p = .06). There was also a gain in daily activities and well-being, as assessed by the Cognitive Failure Questionnaire (p = .04) and the Bravo Wellness Questionnaire (p = .04), respectively. These encouraging results support the effectiveness of the APT-II program in IBD patients. They remain to be confirmed on larger samples with a randomized controlled trial. This project could provide the clinic with a standardized cognitive intervention tool for better cognitive management of these patients. The clinical impact of the project will hopefully be significant.
- Conditions
- Mild Cognitive Impairment, Alzheimer Disease
- Being tested
- Attention Process Training (APT-II)
- Keywords
- mild cognitive impairment, Alzheimer's disease, memory impairment, working memory training, cognitive rehabilitation, Aging
- Medical subject headings
- Cognitive Dysfunction, Alzheimer Disease, Memory Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Attention Process Training (APT-II)Behavioural
The exercises target different attentional components and working memory in the auditory-visual modalities. They are of increasing difficulty while being adapted to the profile of each patient in order to maximize the effects on cognitive reserve. During the sessions, the emphasis is on generalizing the gains to the most problematic daily activities in order to reduce the impact of cognitive disorders in patients' daily life.
| Study group | Role | What they receive |
|---|---|---|
| Attention Process Training (APT-II) | Experimental | Patients in the experimental group receive the APT-II training program (Attention Process Training) individually with a psychologist for 8 weeks (2 sessions/week). The exercises target different attentional components and working memory in the auditory-visual modalities. They are of increasing difficulty while being adapted to each patient's profile in order to maximize the effects on cognitive reserve. During the sessions, the emphasis is on generalizing the gains towards the most problematic daily activities in order to reduce the impact of the patients' cognitive problems in their daily lives. Receives: Behavioral: Attention Process Training (APT-II) |
| Standard care | No intervention | Patients in the control group receive standard routine care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mini Mental State MMSE
The mini-mental state (MMS) or mini-mental state examination (MMSE) or Folstein test is a test for the evaluation of global cognitive functions. This test is used for diagnostic purposes when there is a suspicion of dementia and cognitive disorders. It evaluates temporospatial orientation, memory, attention, language and praxies. Folstein, Folstein and McHugh, 1975; Greco version.
Measured: Prior the program
Mini Mental State MMSE
The mini-mental state (MMS) or mini-mental state examination (MMSE) or Folstein test is a test for the evaluation of global cognitive functions. This test is used for diagnostic purposes when there is a suspicion of dementia and cognitive disorders. It evaluates temporospatial orientation, memory, attention, language and praxies. Folstein, Folstein and McHugh, 1975; Greco version.
Measured: Immediately after the program
Mini Mental State MMSE
The mini-mental state (MMS) or mini-mental state examination (MMSE) or Folstein test is a test for the evaluation of global cognitive functions. This test is used for diagnostic purposes when there is a suspicion of dementia and cognitive disorders. It evaluates temporospatial orientation, memory, attention, language and praxies. Folstein, Folstein and McHugh, 1975; Greco version.
Measured: 3 months follow-up
Mini Mental State MMSE
The mini-mental state (MMS) or mini-mental state examination (MMSE) or Folstein test is a test for the evaluation of global cognitive functions. This test is used for diagnostic purposes when there is a suspicion of dementia and cognitive disorders. It evaluates temporospatial orientation, memory, attention, language and praxies. Folstein, Folstein and McHugh, 1975; Greco version.
Measured: 6 months follow-up
Digit span
The Digit span task is a test evaluating the phonological loop and executive control capabilities of the working memory. The test consists of hearing a series of numbers orally by the examiner and must repeat the same series in the same order or in reverse. This test measures the limited capabilities of a specialized verbal short-term memory system described by Baddeley and Hitch (1974). WAIS-III Weschler,2000 and MEM-III Weschler 2001
Measured: Prior the program
Digit span
The Digit span task is a test evaluating the phonological loop and executive control capabilities of the working memory. The test consists of hearing a series of numbers orally by the examiner and must repeat the same series in the same order or in reverse. This test measures the limited capabilities of a specialized verbal short-term memory system described by Baddeley and Hitch (1974). WAIS-III Weschler,2000 and MEM-III Weschler 2001
Measured: Immediately after the program
Digit span
The Digit span task is a test evaluating the phonological loop and executive control capabilities of the working memory. The test consists of hearing a series of numbers orally by the examiner and must repeat the same series in the same order or in reverse. This test measures the limited capabilities of a specialized verbal short-term memory system described by Baddeley and Hitch (1974). WAIS-III Weschler,2000 and MEM-III Weschler 2001
Measured: 3 months follow-up
Digit span
The Digit span task is a test evaluating the phonological loop and executive control capabilities of the working memory. The test consists of hearing a series of numbers orally by the examiner and must repeat the same series in the same order or in reverse. This test measures the limited capabilities of a specialized verbal short-term memory system described by Baddeley and Hitch (1974). WAIS-III Weschler,2000 and MEM-III Weschler 2001
Measured: 6 months follow-up
PASAT (Naegele and Mazza, 2004)
PASAT is a test that evaluates information processing skills, sustained attention, and shared attention. The individual hears numbers in succession with an interval of 4 seconds. He must add the last digit heard to the last given without losing his attention.
Measured: Prior the program
PASAT (Naegele and Mazza, 2004)
PASAT is a test that evaluates information processing skills, sustained attention, and shared attention. The individual hears numbers in succession with an interval of 4 seconds. He must add the last digit heard to the last given without losing his attention.
Measured: Immediately after the program
PASAT (Naegele and Mazza, 2004)
PASAT is a test that evaluates information processing skills, sustained attention, and shared attention. The individual hears numbers in succession with an interval of 4 seconds. He must add the last digit heard to the last given without losing his attention.
Measured: 3 months follow-up
PASAT (Naegele and Mazza, 2004)
PASAT is a test that evaluates information processing skills, sustained attention, and shared attention. The individual hears numbers in succession with an interval of 4 seconds. He must add the last digit heard to the last given without losing his attention.
Measured: 6 months follow-up
Brown Peterson's Paradigm (Peterson and Peterson, 1959)
Experimental technique to study forgetting in short-term memory and also used as a measure of the central administrator of working memory. The task is to present the subjects with sequences of three consonants. After the presentation of each sequence, the subject is asked to either perform an immediate recall of the consonants or to perform a countdown task from 30 seconds, 20 seconds or 10 seconds. At the end of this count, the subject must give the series again starting from 3 consonants.
Measured: Prior the program
Brown Peterson's Paradigm (Peterson and Peterson, 1959)
Experimental technique to study forgetting in short-term memory and also used as a measure of the central administrator of working memory. The task is to present the subjects with sequences of three consonants. After the presentation of each sequence, the subject is asked to either perform an immediate recall of the consonants or to perform a countdown task from 30 seconds, 20 seconds or 10 seconds. At the end of this count, the subject must give the series again starting from 3 consonants.
Measured: Immediately after the program
Brown Peterson's Paradigm (Peterson and Peterson, 1959)
Experimental technique to study forgetting in short-term memory and also used as a measure of the central administrator of working memory. The task is to present the subjects with sequences of three consonants. After the presentation of each sequence, the subject is asked to either perform an immediate recall of the consonants or to perform a countdown task from 30 seconds, 20 seconds or 10 seconds. At the end of this count, the subject must give the series again starting from 3 consonants.
Measured: 3 months follow-up
Brown Peterson's Paradigm (Peterson and Peterson, 1959)
Experimental technique to study forgetting in short-term memory and also used as a measure of the central administrator of working memory. The task is to present the subjects with sequences of three consonants. After the presentation of each sequence, the subject is asked to either perform an immediate recall of the consonants or to perform a countdown task from 30 seconds, 20 seconds or 10 seconds. At the end of this count, the subject must give the series again starting from 3 consonants.
Measured: 6 months follow-up
Virtual reality memory task
A developed virtual reality task was also administered to the participants to allow a more ecological analysis of episodic memory and divided attention.
Measured: Prior the program
Virtual reality memory task
A developed virtual reality task was also administered to the participants to allow a more ecological analysis of episodic memory and divided attention.
Measured: Immediately after the program
Continious Performance task CPT
CPT is a task of sustained and selective attention on the computer. The task consists of clicking on the space bar of the computer when a letter is presented on the screen except for the letter "X". The person should not click if they see the letter "X" presented. This test takes several minutes.
Measured: Prior the program
Continious Performance task CPT
CPT is a task of sustained and selective attention on the computer. The task consists of clicking on the space bar of the computer when a letter is presented on the screen except for the letter "X". The person should not click if they see the letter "X" presented. This test takes several minutes.
Measured: Immediately after the program
Secondary outcomes (12)
Cognitive Failure Questionnaire
The Cognitive Failure Questionnaire (CFQ) is a questionnaire that evaluates daily cognitive failures.
Measured: Prior the program
Cognitive Failure Questionnaire
The Cognitive Failure Questionnaire (CFQ) is a questionnaire that evaluates daily cognitive failures.
Measured: Immediately after the program
Cognitive Failure Questionnaire
The Cognitive Failure Questionnaire (CFQ) is a questionnaire that evaluates daily cognitive failures.
Measured: 3 months follow-up
Cognitive Failure Questionnaire
The Cognitive Failure Questionnaire (CFQ) is a questionnaire that evaluates daily cognitive failures.
Measured: 6 months follow-up
Bravo's Scale
This scale is a measure of general well-being. The questionnaire contains 18 items that determine how the respondent feels. The first fourteen questions are answered on a 6-point Likert scale (0-5) and the last four questions on a 10-point scale (0-10) to give a maximum score of 110.
A high well-being score is close to 110.
Measured: Prior the program
Bravo's Scale
This scale is a measure of general well-being. The questionnaire contains 18 items that determine how the respondent feels. The first fourteen questions are answered on a 6-point Likert scale (0-5) and the last four questions on a 10-point scale (0-10) to give a maximum score of 110.
A high well-being score is close to 110.
Measured: Immediately after the program
Bravo's Scale
This scale is a measure of general well-being. The questionnaire contains 18 items that determine how the respondent feels. The first fourteen questions are answered on a 6-point Likert scale (0-5) and the last four questions on a 10-point scale (0-10) to give a maximum score of 110.
A high well-being score is close to 110.
Measured: 3 months follow-up
Bravo's Scale
This scale is a measure of general well-being. The questionnaire contains 18 items that determine how the respondent feels. The first fourteen questions are answered on a 6-point Likert scale (0-5) and the last four questions on a 10-point scale (0-10) to give a maximum score of 110.
A high well-being score is close to 110.
Measured: 6 months follow-up
APT-II Attention Questionnaire
The attention questionnaire is a questionnaire of the attention complaint felt by the subject in everyday life. This questionnaire is taken from the APT program.
Measured: Prior the program
APT-II Attention Questionnaire
The attention questionnaire is a questionnaire of the attention complaint felt by the subject in everyday life. This questionnaire is taken from the APT program.
Measured: Immediately after the program
APT-II Attention Questionnaire
The attention questionnaire is a questionnaire of the attention complaint felt by the subject in everyday life. This questionnaire is taken from the APT program.
Measured: 3 months follow-up
APT-II Attention Questionnaire
The attention questionnaire is a questionnaire of the attention complaint felt by the subject in everyday life. This questionnaire is taken from the APT program.
Measured: 6 months follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2020
- Study start1 Feb 2019
- Primary completion30 Jul 2021
- Study completion27 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for Mild Cognitive ImpairmentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- In this single-blind, randomized controlled trial, patients are randomly assigned to either a "cognitive training" experimental group (n=15) or a "standard care" control group (n=15).
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Paris 5 - Rene Descartes
- Sponsor type
- University, hospital or other
- Collaborators
- Assistance Publique - Hôpitaux de Paris
- Responsible party
- Principal investigator, Sophie Blanchet, Ph D, University of Paris 5 - Rene Descartes
- Investigators
- Sophie SB Blanchet, Ph.D, Study director, University of Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04606953
- Sponsor's protocol ID
- APT-II Project
- Acronym
- APT-II
- Status last verified
- Sep 2021
- First submitted
- 16 Jul 2020
- Last updated
- 29 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Baddeley A, Logie R, Bressi S, Della Sala S, Spinnler H. Dementia and working memory. Q J Exp Psychol A. 1986 Nov;38(4):603-18. doi: 10.1080/14640748608401616. No abstract available.
PubMed 3809575Barker-Collo SL, Feigin VL, Lawes CM, Parag V, Senior H, Rodgers A. Reducing attention deficits after stroke using attention process training: a randomized controlled trial. Stroke. 2009 Oct;40(10):3293-8. doi: 10.1161/STROKEAHA.109.558239. Epub 2009 Jul 23.
PubMed 19628801Belleville S, Boller B. Comprendre le stade compensatoire de la maladie d'Alzheimer et agir pour promouvoir la cognition et la plasticite cerebrale. Can J Exp Psychol. 2016 Dec;70(4):288-294. doi: 10.1037/cep0000087.
PubMed 27936842Blanchet S, McCormick L, Belleville S, Gely-Nargeot MC, Joanette Y. [Mild cognitive impairments in the elderly: a critical review]. Rev Neurol (Paris). 2002 Jan;158(1):29-39. French.
PubMed 11938320Kim H, Chey J, Lee S. Effects of multicomponent training of cognitive control on cognitive function and brain activation in older adults. Neurosci Res. 2017 Nov;124:8-15. doi: 10.1016/j.neures.2017.05.004. Epub 2017 Jun 1.
PubMed 28577979Palmese CA, Raskin SA. The rehabilitation of attention in individuals with mild traumatic brain injury, using the APT-II programme. Brain Inj. 2000 Jun;14(6):535-48. doi: 10.1080/026990500120448.
PubMed 10887887Petersen RC, Smith GE, Waring SC, Ivnik RJ, Tangalos EG, Kokmen E. Mild cognitive impairment: clinical characterization and outcome. Arch Neurol. 1999 Mar;56(3):303-8. doi: 10.1001/archneur.56.3.303.
PubMed 10190820Petersen RC, Lopez O, Armstrong MJ, Getchius TSD, Ganguli M, Gloss D, Gronseth GS, Marson D, Pringsheim T, Day GS, Sager M, Stevens J, Rae-Grant A. Author response: Practice guideline update summary: Mild cognitive impairment: Report of the Guideline Development, Dissemination, and Implementation Subcommittee of the American Academy of Neurology. Neurology. 2018 Aug 21;91(8):373-374. doi: 10.1212/WNL.0000000000006042. No abstract available.
PubMed 30126885Plancher G, Gyselinck V, Piolino P. The Integration of Realistic Episodic Memories Relies on Different Working Memory Processes: Evidence from Virtual Navigation. Front Psychol. 2018 Jan 30;9:47. doi: 10.3389/fpsyg.2018.00047. eCollection 2018.
PubMed 29441037Saba M, Blanchet S. [Working memory training in normal and pathological aging: neurocognitive gains and generalization]. Geriatr Psychol Neuropsychiatr Vieil. 2020 Jun 1;18(2):187-195. doi: 10.1684/pnv.2020.0860. French.
PubMed 32554350Simon SS, Tusch ES, Feng NC, Hakansson K, Mohammed AH, Daffner KR. Is Computerized Working Memory Training Effective in Healthy Older Adults? Evidence from a Multi-Site, Randomized Controlled Trial. J Alzheimers Dis. 2018;65(3):931-949. doi: 10.3233/JAD-180455.
PubMed 30103334Telonio A, Blanchet S, Maganaris CN, Baltzopoulos V, Villeneuve S, McFadyen BJ. The division of visual attention affects the transition point from level walking to stair descent in healthy, active older adults. Exp Gerontol. 2014 Feb;50:26-33. doi: 10.1016/j.exger.2013.11.007. Epub 2013 Nov 27.
PubMed 24291246Murray LL, Keeton RJ, Karcher L. Treating attention in mild aphasia: evaluation of attention process training-II. J Commun Disord. 2006 Jan-Feb;39(1):37-61. doi: 10.1016/j.jcomdis.2005.06.001. Epub 2005 Jul 21.
PubMed 16039661Unsworth N, Fukuda K, Awh E, Vogel EK. Working memory and fluid intelligence: capacity, attention control, and secondary memory retrieval. Cogn Psychol. 2014 Jun;71:1-26. doi: 10.1016/j.cogpsych.2014.01.003. Epub 2014 Feb 14.
PubMed 24531497
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Working Memory Training With Attention Process Training (APT-II) in Older Adults With Mild Cognitive Impairment : Impacts on Cognition and Ecological Activities
- ClinicalTrials.gov ID
- NCT04606953
- Acronym / sponsor ID
- APT-II / APT-II Project
- Conditions
- Mild Cognitive Impairment, Alzheimer Disease
- Keywords
- mild cognitive impairment, Alzheimer's disease, memory impairment, working memory training, cognitive rehabilitation, Aging
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- University of Paris 5 - Rene DescartesUniversity, hospital or other
- Collaborators
- Assistance Publique - Hôpitaux de Paris
- Study start
- 1 Feb 2019 (actual)
- Primary completion
- 30 Jul 2021 (actual)
- Study completion
- 27 Sep 2021 (actual)
- First posted
- 28 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Older adults with Mild Cognitive Impairment (MCI) have an increased risk of developing dementia but do not meet the criteria for dementia. Cognitive rehabilitation makes it possible to compensate, at least in part, for cognitive deficits with the ultimate goal of reducing their impact in everyday life. The objective of the research is to evaluate the short- and long-term effectiveness and generalization of an attention and working memory training program (APT-II) on cognition and ecological activities in MCI patients with a randomized controlled trial. Thirty MCI patients will be randomly assigned between a "cognitive training with APT-II" condition and a control (routine care) condition. The intervention will consist of an 8-week individual cognitive training program (2 sessions/week), training different attentional components and working memory. This has the advantage of insisting on the transfer of the acquired knowledge in sessions to daily activities. To evaluate the effectiveness of the treatment, cognitive and functional follow-up measures (including a virtual reality task) are administered at several time intervals. This project should contribute to better management of cognitive disorders by offering a new standardized rehabilitation tool in French to clinical practice.
Detailed description
Older adults with Mild Cognitive Impairment (MCI) have an increased risk of developing dementia, but do not meet the criteria for dementia. Some of these individuals nevertheless remain in a stable state or even return to the norm. Currently, pharmacological treatments have not been shown to be sufficiently effective in treating cognitive deficits. The major challenge is to identify other therapeutic approaches to reduce the risk of cognitive impairment progressing to dementia. Deficits in working memory, which are very common in these individuals, have a prognostic value for progression to dementia of the Alzheimer's type. Cognitive re-education makes it possible to compensate, at least in part, for cognitive disorders with the ultimate goal of reducing their repercussions in daily life. Executive control training can improve working memory and attention, but how this gain is transferred to activities of daily living (ADLs) remains poorly understood to date. The generalization of cognitive gains to ADLs is crucial, however, as this generalization may contribute to patients' functional autonomy.
This project aims to evaluate the effectiveness of attention and working memory training (APT-II) on cognitive function and ecological activities in MCI patients by means of a single-blind randomized controlled trial. Working memory is involved in information manipulation and attentional processes. This ability is called upon in higher cognitive functions such as language, reasoning, comprehension, but also in various complex ADL situations. Deficits in working memory thus contribute significantly to other cognitive or functional impairments in MCI patients. To date, some working memory training has been shown to have an immediate impact on working memory in this population. However, long-term maintenance and impact on daily life have not been demonstrated in this population. Researchers of this study propose to fill this gap by using the APT-II (or Attention Process Training) program, which focuses on the transfer of cognitive gains from the start of training. Indeed, the APT-II program was translated from English to French by the scientific coordinator (S. Blanchet). The English version has already been validated in various populations with mild cognitive dysfunction following brain injury, stroke or small vessel brain disease. The efficacy of APT-II has never been studied in older adults with IBD. For the first time a research team evaluate the short- and long-term efficacy of this program in MCI patients on cognition and ADLs using virtual reality. This new technology provides an ecological and objective measure for the evaluation of memory and other cognitive functions while simulating naturalistic and controlled situations. The objective is therefore to evaluate the effectiveness of an attention and working memory training program (APT-II) on cognitive function in patients with MCI. To achieve this objective, patients with MCI are randomly assigned to an APT-II program or to a control group. Cognitive training with the APT-II program will include progressively more difficult and adaptive exercises and will be varied to facilitate near and far cognitive transfer. Attention, working memory and episodic memory are measured at different time intervals (before, immediately after, 3 and 6 months after training). A unique feature of the cognitive training program is its emphasis on generalization by teaching participants how to maximize the transfer of the attention management strategies learned during the sessions to their various ADLs requiring attention and executive control. Homework exercises targeting these different cognitive functions in ADLs are also provided between sessions.
The protocol is offered to elderly people with mild cognitive impairment. In this single-blind randomized controlled trial, participants are randomly assigned either to a "cognitive training" experimental group (n=20) or a "standard care" control group (n=20). Recruitment is multi-centric, and takes place via memory consultations from several sites: Tenon Hospital (collaboration with Dr Eric Bouvard), AP-HP Sorbonne University, and Dr Mettling's private neurology practice (Paris XI). MCI patients are selected according to the criteria of Petersen (2004). A battery of standardized neuropsychological tests is first administered to ensure that participants meet our criteria. Patients must be at least 55 years of age and have an impairment of attention, exécutive, memory and/or working memory as evidenced by impaired performance on tests assessing attention or executive function (score 1.5 standard deviation below the norm on these tests). Participants meeting the selection criteria are invited to continue the study. The project has already been approved by the Committee for the Protection of Persons (CPP) EST-III of the ANSM (BCR ID: 2018-A02377-48, N°CPP: 18.11.05, N° 18.08.21.66617). Patients in the experimental group receive the APT-II training program individually with a psychologist for 8 weeks (2 sessions/week). The exercises target different attentional components and working memory in the auditory-visual modalities. This exercices are of increasing difficulty while being adapted to each patient's profile in order to maximize the effects on cognitive reserve. During the sessions, the emphasis is on generalizing the gains towards the most problematic daily activities in order to reduce the impact of the patients' cognitive problems in their daily lives. Patients in the control group receive standard routine care. In order to test the impact of the APT-II training program on cognitive function and daily activities, cognitive and functional follow-up measures are administered in a blind condition just before (T0), after (T1), and 3 (T2) and 6 months (T3) after the intervention. The last two measures will be used to study long-term maintenance of earnings. The cognitive follow-up measures will test the effects of near (attention, working memory) and far (episodic memory) cognitive transfers and generalization to daily activities with questionnaires. Functional follow-up measures include a virtual reality task assessing episodic memory in the presence of interferences in order to examine the effects of training on an ecological situation with high demands on attentional resources.
MCI patients who received the APT-II training program should perform better on attention and working memory tasks after training, with a distant transfer to episodic memory tasks compared to the control group who received standard care during the training time interval. Following cognitive training, MCI patients should also be less susceptible to environmental interferences as assessed with the virtual reality task, while reporting fewer cognitive complaints in everyday life with maintenance of these gains over time. In patients in the control group, it is anticipated that there will be no difference in follow-up measures between the different times or the presence of decreased performance as these patients are at risk of developing neurodegenerative pathology. In a preliminary study evaluating the efficacy of the APT-II programme by the same team of research, six MCI patients (m = 68 ± 10.56 years) attended 10 sessions of the APT-II programme (2 sessions/week). Statistical analyses indicate that after cognitive training, MCI patients tended to improve their performance on a working memory task (upside down number span, p = .06). There was also a gain in daily activities and well-being, as assessed by the Cognitive Failure Questionnaire (p = .04) and the Bravo Wellness Questionnaire (p = .04), respectively. These encouraging results support the effectiveness of the APT-II program in IBD patients. They remain to be confirmed on larger samples with a randomized controlled trial. This project could provide the clinic with a standardized cognitive intervention tool for better cognitive management of these patients. The clinical impact of the project will hopefully be significant.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- In this single-blind, randomized controlled trial, patients are randomly assigned to either a "cognitive training" experimental group (n=15) or a "standard care" control group (n=15).
| Arm | Type | Receives |
|---|---|---|
| Attention Process Training (APT-II) | Experimental | Behavioral: Attention Process Training (APT-II)Patients in the experimental group receive the APT-II training program (Attention Process Training) individually with a psychologist for 8 weeks (2 sessions/week). The exercises target different attentional components and working memory in the auditory-visual modalities. They are of increasing difficulty while being adapted to each patient's profile in order to maximize the effects on cognitive reserve. During the sessions, the emphasis is on generalizing the gains towards the most problematic daily activities in order to reduce the impact of the patients' cognitive problems in their daily lives. |
| Standard care | No intervention | –Patients in the control group receive standard routine care. |
Who may qualify
- Ages
- 55 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- MCI criteria according to Petersen 2004
- 55 years and over
- Native French-speaking or bilingual participant living in the Paris region
- Normal or corrected vision and hearing
- Presence of episodic memory and/or attention and/or working memory impairment as evidenced by substandard performance on neuropsychological test(s) evaluating these processes (-1.5 deviations from the norms)
Key exclusion criteria (8 listed)
- Presence of dementia
- Significant impact of cognitive impairment on activities of daily living requiring external assistance or institutionalization
- Stroke or brain injury
- Presence of moderate to severe psychiatric disorders
- Ethylism
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Attention Process Training (APT-II)The exercises target different attentional components and working memory in the auditory-visual modalities. They are of increasing difficulty while being adapted to the profile of each patient in order to maximize the effects on cognitive reserve. During the sessions, the emphasis is on generalizing the gains to the most problematic daily activities in order to reduce the impact of cognitive disorders in patients' daily life. | Behavioural | Attention Process Training (APT-II) |
Primary outcome
Mini Mental State MMSE
Time frame: Prior the program
The mini-mental state (MMS) or mini-mental state examination (MMSE) or Folstein test is a test for the evaluation of global cognitive functions. This test is used for diagnostic purposes when there is a suspicion of dementia and cognitive disorders. It evaluates temporospatial orientation, memory, attention, language and praxies. Folstein, Folstein and McHugh, 1975; Greco version.
Mini Mental State MMSE
Time frame: Immediately after the program
The mini-mental state (MMS) or mini-mental state examination (MMSE) or Folstein test is a test for the evaluation of global cognitive functions. This test is used for diagnostic purposes when there is a suspicion of dementia and cognitive disorders. It evaluates temporospatial orientation, memory, attention, language and praxies. Folstein, Folstein and McHugh, 1975; Greco version.
Mini Mental State MMSE
Time frame: 3 months follow-up
The mini-mental state (MMS) or mini-mental state examination (MMSE) or Folstein test is a test for the evaluation of global cognitive functions. This test is used for diagnostic purposes when there is a suspicion of dementia and cognitive disorders. It evaluates temporospatial orientation, memory, attention, language and praxies. Folstein, Folstein and McHugh, 1975; Greco version.
Mini Mental State MMSE
Time frame: 6 months follow-up
The mini-mental state (MMS) or mini-mental state examination (MMSE) or Folstein test is a test for the evaluation of global cognitive functions. This test is used for diagnostic purposes when there is a suspicion of dementia and cognitive disorders. It evaluates temporospatial orientation, memory, attention, language and praxies. Folstein, Folstein and McHugh, 1975; Greco version.
Digit span
Time frame: Prior the program
The Digit span task is a test evaluating the phonological loop and executive control capabilities of the working memory. The test consists of hearing a series of numbers orally by the examiner and must repeat the same series in the same order or in reverse. This test measures the limited capabilities of a specialized verbal short-term memory system described by Baddeley and Hitch (1974). WAIS-III Weschler,2000 and MEM-III Weschler 2001
Digit span
Time frame: Immediately after the program
The Digit span task is a test evaluating the phonological loop and executive control capabilities of the working memory. The test consists of hearing a series of numbers orally by the examiner and must repeat the same series in the same order or in reverse. This test measures the limited capabilities of a specialized verbal short-term memory system described by Baddeley and Hitch (1974). WAIS-III Weschler,2000 and MEM-III Weschler 2001
Digit span
Time frame: 3 months follow-up
The Digit span task is a test evaluating the phonological loop and executive control capabilities of the working memory. The test consists of hearing a series of numbers orally by the examiner and must repeat the same series in the same order or in reverse. This test measures the limited capabilities of a specialized verbal short-term memory system described by Baddeley and Hitch (1974). WAIS-III Weschler,2000 and MEM-III Weschler 2001
Digit span
Time frame: 6 months follow-up
The Digit span task is a test evaluating the phonological loop and executive control capabilities of the working memory. The test consists of hearing a series of numbers orally by the examiner and must repeat the same series in the same order or in reverse. This test measures the limited capabilities of a specialized verbal short-term memory system described by Baddeley and Hitch (1974). WAIS-III Weschler,2000 and MEM-III Weschler 2001
PASAT (Naegele and Mazza, 2004)
Time frame: Prior the program
PASAT is a test that evaluates information processing skills, sustained attention, and shared attention. The individual hears numbers in succession with an interval of 4 seconds. He must add the last digit heard to the last given without losing his attention.
PASAT (Naegele and Mazza, 2004)
Time frame: Immediately after the program
PASAT is a test that evaluates information processing skills, sustained attention, and shared attention. The individual hears numbers in succession with an interval of 4 seconds. He must add the last digit heard to the last given without losing his attention.
PASAT (Naegele and Mazza, 2004)
Time frame: 3 months follow-up
PASAT is a test that evaluates information processing skills, sustained attention, and shared attention. The individual hears numbers in succession with an interval of 4 seconds. He must add the last digit heard to the last given without losing his attention.
PASAT (Naegele and Mazza, 2004)
Time frame: 6 months follow-up
PASAT is a test that evaluates information processing skills, sustained attention, and shared attention. The individual hears numbers in succession with an interval of 4 seconds. He must add the last digit heard to the last given without losing his attention.
Brown Peterson's Paradigm (Peterson and Peterson, 1959)
Time frame: Prior the program
Experimental technique to study forgetting in short-term memory and also used as a measure of the central administrator of working memory. The task is to present the subjects with sequences of three consonants. After the presentation of each sequence, the subject is asked to either perform an immediate recall of the consonants or to perform a countdown task from 30 seconds, 20 seconds or 10 seconds. At the end of this count, the subject must give the series again starting from 3 consonants.
Brown Peterson's Paradigm (Peterson and Peterson, 1959)
Time frame: Immediately after the program
Experimental technique to study forgetting in short-term memory and also used as a measure of the central administrator of working memory. The task is to present the subjects with sequences of three consonants. After the presentation of each sequence, the subject is asked to either perform an immediate recall of the consonants or to perform a countdown task from 30 seconds, 20 seconds or 10 seconds. At the end of this count, the subject must give the series again starting from 3 consonants.
Brown Peterson's Paradigm (Peterson and Peterson, 1959)
Time frame: 3 months follow-up
Experimental technique to study forgetting in short-term memory and also used as a measure of the central administrator of working memory. The task is to present the subjects with sequences of three consonants. After the presentation of each sequence, the subject is asked to either perform an immediate recall of the consonants or to perform a countdown task from 30 seconds, 20 seconds or 10 seconds. At the end of this count, the subject must give the series again starting from 3 consonants.
Brown Peterson's Paradigm (Peterson and Peterson, 1959)
Time frame: 6 months follow-up
Experimental technique to study forgetting in short-term memory and also used as a measure of the central administrator of working memory. The task is to present the subjects with sequences of three consonants. After the presentation of each sequence, the subject is asked to either perform an immediate recall of the consonants or to perform a countdown task from 30 seconds, 20 seconds or 10 seconds. At the end of this count, the subject must give the series again starting from 3 consonants.
Virtual reality memory task
Time frame: Prior the program
A developed virtual reality task was also administered to the participants to allow a more ecological analysis of episodic memory and divided attention.
Virtual reality memory task
Time frame: Immediately after the program
A developed virtual reality task was also administered to the participants to allow a more ecological analysis of episodic memory and divided attention.
Continious Performance task CPT
Time frame: Prior the program
CPT is a task of sustained and selective attention on the computer. The task consists of clicking on the space bar of the computer when a letter is presented on the screen except for the letter "X". The person should not click if they see the letter "X" presented. This test takes several minutes.
Continious Performance task CPT
Time frame: Immediately after the program
CPT is a task of sustained and selective attention on the computer. The task consists of clicking on the space bar of the computer when a letter is presented on the screen except for the letter "X". The person should not click if they see the letter "X" presented. This test takes several minutes.
12 secondary outcomes
Cognitive Failure Questionnaire
Time frame: Prior the program
Cognitive Failure Questionnaire
Time frame: Immediately after the program
Cognitive Failure Questionnaire
Time frame: 3 months follow-up
Cognitive Failure Questionnaire
Time frame: 6 months follow-up
Bravo's Scale
Time frame: Prior the program
Bravo's Scale
Time frame: Immediately after the program
Bravo's Scale
Time frame: 3 months follow-up
Bravo's Scale
Time frame: 6 months follow-up
APT-II Attention Questionnaire
Time frame: Prior the program
APT-II Attention Questionnaire
Time frame: Immediately after the program
APT-II Attention Questionnaire
Time frame: 3 months follow-up
APT-II Attention Questionnaire
Time frame: 6 months follow-up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2021.
- Background: PubMed 3809575Baddeley A, Logie R, Bressi S, Della Sala S, Spinnler H. Dementia and working memory. Q J Exp Psychol A. 1986 Nov;38(4):603-18. doi: 10.1080/14640748608401616. No abstract available.
- Background: PubMed 19628801Barker-Collo SL, Feigin VL, Lawes CM, Parag V, Senior H, Rodgers A. Reducing attention deficits after stroke using attention process training: a randomized controlled trial. Stroke. 2009 Oct;40(10):3293-8. doi: 10.1161/STROKEAHA.109.558239. Epub 2009 Jul 23.
- Background: PubMed 27936842Belleville S, Boller B. Comprendre le stade compensatoire de la maladie d'Alzheimer et agir pour promouvoir la cognition et la plasticite cerebrale. Can J Exp Psychol. 2016 Dec;70(4):288-294. doi: 10.1037/cep0000087.
- Background: PubMed 11938320Blanchet S, McCormick L, Belleville S, Gely-Nargeot MC, Joanette Y. [Mild cognitive impairments in the elderly: a critical review]. Rev Neurol (Paris). 2002 Jan;158(1):29-39. French.
- Background: PubMed 28577979Kim H, Chey J, Lee S. Effects of multicomponent training of cognitive control on cognitive function and brain activation in older adults. Neurosci Res. 2017 Nov;124:8-15. doi: 10.1016/j.neures.2017.05.004. Epub 2017 Jun 1.
- Background: PubMed 10887887Palmese CA, Raskin SA. The rehabilitation of attention in individuals with mild traumatic brain injury, using the APT-II programme. Brain Inj. 2000 Jun;14(6):535-48. doi: 10.1080/026990500120448.
- Background: PubMed 10190820Petersen RC, Smith GE, Waring SC, Ivnik RJ, Tangalos EG, Kokmen E. Mild cognitive impairment: clinical characterization and outcome. Arch Neurol. 1999 Mar;56(3):303-8. doi: 10.1001/archneur.56.3.303.
- Background: PubMed 30126885Petersen RC, Lopez O, Armstrong MJ, Getchius TSD, Ganguli M, Gloss D, Gronseth GS, Marson D, Pringsheim T, Day GS, Sager M, Stevens J, Rae-Grant A. Author response: Practice guideline update summary: Mild cognitive impairment: Report of the Guideline Development, Dissemination, and Implementation Subcommittee of the American Academy of Neurology. Neurology. 2018 Aug 21;91(8):373-374. doi: 10.1212/WNL.0000000000006042. No abstract available.
- Background: PubMed 29441037Plancher G, Gyselinck V, Piolino P. The Integration of Realistic Episodic Memories Relies on Different Working Memory Processes: Evidence from Virtual Navigation. Front Psychol. 2018 Jan 30;9:47. doi: 10.3389/fpsyg.2018.00047. eCollection 2018.
- Background: PubMed 32554350Saba M, Blanchet S. [Working memory training in normal and pathological aging: neurocognitive gains and generalization]. Geriatr Psychol Neuropsychiatr Vieil. 2020 Jun 1;18(2):187-195. doi: 10.1684/pnv.2020.0860. French.
- Background: PubMed 30103334Simon SS, Tusch ES, Feng NC, Hakansson K, Mohammed AH, Daffner KR. Is Computerized Working Memory Training Effective in Healthy Older Adults? Evidence from a Multi-Site, Randomized Controlled Trial. J Alzheimers Dis. 2018;65(3):931-949. doi: 10.3233/JAD-180455.
- Background: PubMed 24291246Telonio A, Blanchet S, Maganaris CN, Baltzopoulos V, Villeneuve S, McFadyen BJ. The division of visual attention affects the transition point from level walking to stair descent in healthy, active older adults. Exp Gerontol. 2014 Feb;50:26-33. doi: 10.1016/j.exger.2013.11.007. Epub 2013 Nov 27.
- Individual participant dataSharing planned: No
Related trials for Mild Cognitive Impairment
RecruitingPhase 1
PET Imaging of Phosphodiesterase-4 (PDE4) in Volunteers With Alzheimer Disease (AD) or Mild Cognitive Impairment (MCI)
Alzheimer s Disease, Mild Cognitive Impairment
RecruitingObservational study
Community-based Screening for Alzheimer's Disease
Alzheimer's Disease(AD), Mild Cognitive Impairment (MCI)
RecruitingObservational study
InRAD Observational Study
Alzheimer's Disease(AD), Mild Cognitive Impairment (MCI)
Recruiting
Treating Insomnia in Mild Cognitive Impairment
Mild Cognitive Impairment (MCI), Insomnia
Recruiting
Telehealth-Adapted Compensatory Training and Intervention for Cognition
MCI, Mild Cognitive Impairment
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sophie SB Blanchet, Ph.D study director
University of Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Attention Process Training (APT-II) in people with Mild Cognitive Impairment and Alzheimer Disease, run by University of Paris 5 - Rene Descartes at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mini Mental State MMSE (time frame: Prior the program). The study lists 20 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04606953, which also lists 14 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Sep 2021.