Age-Related Memory DisordersNCT04245579
Effectiveness of a Cognitive Training Program (UMAM Method) in Elderly People Without Dementia
A study testing Multifactorial Memory Training Program (UMAM method) in people with Age-Related Memory Disorders, run by Madrid Salud at 1 site in Spain.
Trial summary
The study is oriented to analyze the effectiveness of a cognitive training method (UMAM) on cognitive functions, subjective memory and mood state in elderly people without dementia. On the other hand, the study aims to examine whether variables such as cognitive reserve (e.g. Read more about this study
- Who is it for?
- Ages 60 years and olderHealthy volunteers can take part
- Conditions the study is for
- Age-Related Memory Disorders
- What is being tested?
- Multifactorial Memory Training Program (UMAM method)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 199 participants
- Where
- 1 siteSpain
- Study dates
- Oct 2013to May 2015
- 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 60 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Being over 60 years old.
- Having a global cognitive performance > 23 in the Mini Mental State Examination Test.
- Having no history of neurological or serious psychiatric disorders (severe psycho-affective disorders and psychosis or other psychiatric disorders like alcoholism).
Who cannot join
- Chronic use of anxiolytics.
- Chronic use of neuroleptics.
- Chronic use of anticonvulsants.
- Having hearing or vision impairments that would preclude testing.
- Magnetic Resonance Imaging (MRI) contraindications.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Cognitive Training in Elders Without Dementia Using UMAM Method. Genetic, Brain Volume and Cognitive Reserve Predictors: A Randomized Controlled Study
The study is oriented to analyze the effectiveness of a cognitive training method (UMAM) on cognitive functions, subjective memory and mood state in elderly people without dementia. On the other hand, the study aims to examine whether variables such as cognitive reserve (e.g. educational level), APOE genotype and intracranial volume are related to increased benefit after the intervention. The researchers hope to find that greater cognitive reserve, not having the APOE allele ε4, and a greater volume of memory-related brain areas, are associated with better outcomes after the cognitive intervention.
- Conditions
- Age-Related Memory Disorders
- Being tested
- Multifactorial Memory Training Program (UMAM method)
- Keywords
- cognitive training, memory failures, APOE, brain volume, cognitive reserve
- Medical subject headings
- Memory Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multifactorial Memory Training Program (UMAM method)Other
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group | Experimental | The experimental group carried out a 30-session multi-factorial group memory training program (UMAM method), with a frequency of three weekly sessions of 90 minutes each. The training program consists of four modules: 1- Stimulation of cognitive processes; learning and practicing internal memory strategies and solving everyday forgetfulness; 2- Instruction in basic concepts about memory; 3- Intervention on daily living and forgetting experiences, using internal and external strategies to solve everyday memory failures; 4- Metacognition or metamemory: the subjects were to reflect about their cognitive failures by analyzing the causes and variables of those failures.
In addition, the experimental group followed the standard activities in which all users attending the Center are involved (planned interviews, dialogue-conferences, general health recommendations, etc.). Receives: Other: Multifactorial Memory Training Program (UMAM method) |
| Control Group | No intervention | The Control Group followed the standard activities in which all users attending the Center are involved (planned interviews, dialogue-conferences, general health recommendations, etc.). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in general cognition
The measure of the post-intervention change in general cognition, assessed with the Mini Mental State Examination Test (MMSE) and the 7 Minutes Test (7M).The score ranges from 0 to 30 points (MMSE) and from 0 to 89 points (7M). In both cases, the higher scores indicate a better outcome.
Measured: This cognitive variable was assessed before and after the intervention. The interval between the pre and post-intervention assessment was 6 months.
Change in verbal memory
The measure of the post-intervention change in verbal memory, assessed with the Word List Test of the Wechsler Memory Scale-III. The score ranges from 0 to 48 points. Higher scores indicate a better outcome.
Measured: This cognitive variable was assessed before and after the intervention. The interval between the pre and post-intervention assessment was 6 months.
Change in logical memory
The measure of the post-intervention change in immediate and delayed logical memory, assessed with the Logical Memory Test (immediate and delayed units) of the Wechsler Memory Scale-III. The score ranges from 0 to 75 points (immediate units) and from 0 to 50 (delayed units). Higher scores indicate a better outcome.
Measured: This cognitive variable was assessed before and after the intervention. The interval between the pre and post-intervention assessment was 6 months.
Change in visual memory
The measure of the post-intervention change in visual memory, assessed with the Rey memory test (form B). The score ranges from 0 to 22 points. Higher scores indicate a better outcome.
Measured: This cognitive variable was assessed before and after the intervention. The interval between the pre and post-intervention assessment was 6 months.
Change in daily memory
The measure of the post-intervention change in daily memory, assessed with the Rivermead Behavioral Memory Test. The score ranges from 0 to 24 points. Higher scores indicate a better outcome.
Measured: This cognitive variable was assessed before and after the intervention. The interval between the pre and post-intervention assessment was 6 months.
Change in attentional amplitude
The measure of the post-intervention change in attentional amplitude, assessed with the Direct Digit Test of the Wechsler Memory Scale-III. The score ranges from 0 to 16 points. Higher scores indicate a better outcome.
Measured: This cognitive variable was assessed before and after the intervention. The interval between the pre and post-intervention assessment was 6 months.
Change in attentional control
The measure of the post-intervention change in attentional control, assessed with the Inverse Digit Test of the Wechsler Memory Scale-III. The score ranges from 0 to 14 points. Higher scores indicate a better outcome.
Measured: This cognitive variable was assessed before and after the intervention. The interval between the pre and post-intervention assessment was 6 months.
Change in attention and processing speed
The measure of the post-intervention change in attention, assessed with the Trail Making Test, form A. The score ranges from 0 to 200 points. Higher scores indicate a worse outcome.
Measured: This cognitive variable was assessed before and after the intervention. The interval between the pre and post-intervention assessment was 6 months.
Change in alternating attention and planning
The measure of the post-intervention change in alternating attention and planning, assessed with the Trail Making Test, form B. The score ranges from 0 to 400 points. Higher scores indicate a worse outcome.
Measured: This cognitive variable was assessed before and after the intervention. The interval between the pre and post-intervention assessment was 6 months.
Change in naming ability (language)
The measure of the post-intervention change in naming ability, assessed with the Boston Naming Test. The score ranges from 0 to 60 points. Higher scores indicate a better outcome.
Measured: This cognitive variable was assessed before and after the intervention. The interval between the pre and post-intervention assessment was 6 months.
Change in verbal fluency (language)
The measure of the post-intervention change in phonologic and semantic verbal fluency, assessed with the Phonological Verbal Fluency Test and the Semantic Fluency Test respectively. The score goes from zero onwards (there is no upper limit). Higher scores indicate a better outcome.
Measured: This cognitive variable was assessed before and after the intervention. The interval between the pre and post-intervention assessment was 6 months.
Change in subjective memory
The measure of the post-intervention change in Subjective Memory, assessed with the Memory Failures of Everyday Questionnaire.The score ranges from 0 to 56 points. Higher scores indicate a worse outcome.
Measured: This variable was assessed before and after the intervention. The interval between the pre and post-intervention assessment was 6 months.
Change in mood
The measure of the post-intervention change in mood, assessed with the Geriatric Depression Scale. The score ranges from 0 to 15 points. Higher scores indicate a worse outcome.
Measured: This variable was assessed before and after the intervention. The interval between the pre and post-intervention assessment was 6 months.
The Cognitive Reserve as a predictor of change.
The Cognitive Reserve was assessed with Rami Test. The score ranges from 0 to 25 points.
Measured: Cognitive Reserve was assessed in the pre-intervention assessment.
The Genetic Profile as a predictor of change.
The Genetic Profile was obtained by genetic analysis employing a blood test. APOE gene has been coded as 1 (meaning no ε4 allele), or 0 (for at least one ε4 allele).
Measured: The Genetic Profile was assessed in the pre-intervention assessment.
The Brain Volume as a predictor of change.
The Brain Volume (total gray volume, left hippocampus, right hippocampus and total intracranial volume) was assessed by magnetic resonance imaging. Unit of measure: mm3.
Measured: The Brain Volume was assessed in the pre-intervention assessment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2020
- Study startOct 2013
- Primary completionMay 2015
- Study completionMay 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Age-Related Memory DisordersStudies 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
- Masking
- None (open label)
- Enrolment
- 199 participants (actual)
Sponsor and investigators
- Lead sponsor
- Madrid Salud
- Sponsor type
- University, hospital or other
- Collaborators
- Universidad Complutense de Madrid, Hospital San Carlos, Madrid, Centro de Tecnología Biomédica, Madrid
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04245579
- Sponsor's protocol ID
- 15/382-E_BS
- Status last verified
- Jan 2020
- First submitted
- 22 Dec 2019
- Last updated
- 29 Jan 2020
- Results posted
- No
- Individual data sharing
- No
Publications
Montejo Carrasco P, Montenegro-Pena M, Prada Crespo D, Rodriguez Rojo I, Barabash Bustelo A, Montejo Rubio B, Marcos Dolado A, Maestu Unturbe F, Delgado Losada ML. APOE genotype, hippocampal volume, and cognitive reserve predict improvement by cognitive training in older adults without dementia: a randomized controlled trial. Cogn Process. 2024 Nov;25(4):673-689. doi: 10.1007/s10339-024-01202-3. Epub 2024 Jun 19.
PubMed 38896211
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cognitive Training in Elders Without Dementia Using UMAM Method. Genetic, Brain Volume and Cognitive Reserve Predictors: A Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT04245579
- Acronym / sponsor ID
- 15/382-E_BS
- Conditions
- Age-Related Memory Disorders
- Keywords
- cognitive training, memory failures, APOE, brain volume, cognitive reserve
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 199 participants (actual)
- Lead sponsor
- Madrid SaludUniversity, hospital or other
- Collaborators
- Universidad Complutense de Madrid, Hospital San Carlos, Madrid, Centro de Tecnología Biomédica, Madrid
- Study start
- Oct 2013 (actual)
- Primary completion
- May 2015 (actual)
- Study completion
- May 2015 (actual)
- First posted
- 29 Jan 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.
The study is oriented to analyze the effectiveness of a cognitive training method (UMAM) on cognitive functions, subjective memory and mood state in elderly people without dementia. On the other hand, the study aims to examine whether variables such as cognitive reserve (e.g. educational level), APOE genotype and intracranial volume are related to increased benefit after the intervention. The researchers hope to find that greater cognitive reserve, not having the APOE allele ε4, and a greater volume of memory-related brain areas, are associated with better outcomes after the cognitive intervention.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental Group | Experimental | Other: Multifactorial Memory Training Program (UMAM method)The experimental group carried out a 30-session multi-factorial group memory training program (UMAM method), with a frequency of three weekly sessions of 90 minutes each. The training program consists of four modules: 1- Stimulation of cognitive processes; learning and practicing internal memory strategies and solving everyday forgetfulness; 2- Instruction in basic concepts about memory; 3- Intervention on daily living and forgetting experiences, using internal and external strategies to solve everyday memory failures; 4- Metacognition or metamemory: the subjects were to reflect about their cognitive failures by analyzing the causes and variables of those failures. In addition, the experimental group followed the standard activities in which all users attending the Center are involved (planned interviews, dialogue-conferences, general health recommendations, etc.). |
| Control Group | No intervention | –The Control Group followed the standard activities in which all users attending the Center are involved (planned interviews, dialogue-conferences, general health recommendations, etc.). |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Being over 60 years old.
- Having a global cognitive performance > 23 in the Mini Mental State Examination Test.
- Having no history of neurological or serious psychiatric disorders (severe psycho-affective disorders and psychosis or other psychiatric disorders like alcoholism).
Key exclusion criteria (5 listed)
- Chronic use of anxiolytics.
- Chronic use of neuroleptics.
- Chronic use of anticonvulsants.
- Having hearing or vision impairments that would preclude testing.
- Magnetic Resonance Imaging (MRI) contraindications.
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 |
|---|---|---|
| Multifactorial Memory Training Program (UMAM method) | Other | Experimental Group |
Primary outcome
Change in general cognition
Time frame: This cognitive variable was assessed before and after the intervention. The interval between the pre and post-intervention assessment was 6 months.
The measure of the post-intervention change in general cognition, assessed with the Mini Mental State Examination Test (MMSE) and the 7 Minutes Test (7M).The score ranges from 0 to 30 points (MMSE) and from 0 to 89 points (7M). In both cases, the higher scores indicate a better outcome.
Change in verbal memory
Time frame: This cognitive variable was assessed before and after the intervention. The interval between the pre and post-intervention assessment was 6 months.
The measure of the post-intervention change in verbal memory, assessed with the Word List Test of the Wechsler Memory Scale-III. The score ranges from 0 to 48 points. Higher scores indicate a better outcome.
Change in logical memory
Time frame: This cognitive variable was assessed before and after the intervention. The interval between the pre and post-intervention assessment was 6 months.
The measure of the post-intervention change in immediate and delayed logical memory, assessed with the Logical Memory Test (immediate and delayed units) of the Wechsler Memory Scale-III. The score ranges from 0 to 75 points (immediate units) and from 0 to 50 (delayed units). Higher scores indicate a better outcome.
Change in visual memory
Time frame: This cognitive variable was assessed before and after the intervention. The interval between the pre and post-intervention assessment was 6 months.
The measure of the post-intervention change in visual memory, assessed with the Rey memory test (form B). The score ranges from 0 to 22 points. Higher scores indicate a better outcome.
Change in daily memory
Time frame: This cognitive variable was assessed before and after the intervention. The interval between the pre and post-intervention assessment was 6 months.
The measure of the post-intervention change in daily memory, assessed with the Rivermead Behavioral Memory Test. The score ranges from 0 to 24 points. Higher scores indicate a better outcome.
Change in attentional amplitude
Time frame: This cognitive variable was assessed before and after the intervention. The interval between the pre and post-intervention assessment was 6 months.
The measure of the post-intervention change in attentional amplitude, assessed with the Direct Digit Test of the Wechsler Memory Scale-III. The score ranges from 0 to 16 points. Higher scores indicate a better outcome.
Change in attentional control
Time frame: This cognitive variable was assessed before and after the intervention. The interval between the pre and post-intervention assessment was 6 months.
The measure of the post-intervention change in attentional control, assessed with the Inverse Digit Test of the Wechsler Memory Scale-III. The score ranges from 0 to 14 points. Higher scores indicate a better outcome.
Change in attention and processing speed
Time frame: This cognitive variable was assessed before and after the intervention. The interval between the pre and post-intervention assessment was 6 months.
The measure of the post-intervention change in attention, assessed with the Trail Making Test, form A. The score ranges from 0 to 200 points. Higher scores indicate a worse outcome.
Change in alternating attention and planning
Time frame: This cognitive variable was assessed before and after the intervention. The interval between the pre and post-intervention assessment was 6 months.
The measure of the post-intervention change in alternating attention and planning, assessed with the Trail Making Test, form B. The score ranges from 0 to 400 points. Higher scores indicate a worse outcome.
Change in naming ability (language)
Time frame: This cognitive variable was assessed before and after the intervention. The interval between the pre and post-intervention assessment was 6 months.
The measure of the post-intervention change in naming ability, assessed with the Boston Naming Test. The score ranges from 0 to 60 points. Higher scores indicate a better outcome.
Change in verbal fluency (language)
Time frame: This cognitive variable was assessed before and after the intervention. The interval between the pre and post-intervention assessment was 6 months.
The measure of the post-intervention change in phonologic and semantic verbal fluency, assessed with the Phonological Verbal Fluency Test and the Semantic Fluency Test respectively. The score goes from zero onwards (there is no upper limit). Higher scores indicate a better outcome.
Change in subjective memory
Time frame: This variable was assessed before and after the intervention. The interval between the pre and post-intervention assessment was 6 months.
The measure of the post-intervention change in Subjective Memory, assessed with the Memory Failures of Everyday Questionnaire.The score ranges from 0 to 56 points. Higher scores indicate a worse outcome.
Change in mood
Time frame: This variable was assessed before and after the intervention. The interval between the pre and post-intervention assessment was 6 months.
The measure of the post-intervention change in mood, assessed with the Geriatric Depression Scale. The score ranges from 0 to 15 points. Higher scores indicate a worse outcome.
The Cognitive Reserve as a predictor of change.
Time frame: Cognitive Reserve was assessed in the pre-intervention assessment.
The Cognitive Reserve was assessed with Rami Test. The score ranges from 0 to 25 points.
The Genetic Profile as a predictor of change.
Time frame: The Genetic Profile was assessed in the pre-intervention assessment.
The Genetic Profile was obtained by genetic analysis employing a blood test. APOE gene has been coded as 1 (meaning no ε4 allele), or 0 (for at least one ε4 allele).
The Brain Volume as a predictor of change.
Time frame: The Brain Volume was assessed in the pre-intervention assessment.
The Brain Volume (total gray volume, left hippocampus, right hippocampus and total intracranial volume) was assessed by magnetic resonance imaging. Unit of measure: mm3.
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 Jan 2020.
- Derived from this study: PubMed 38896211Montejo Carrasco P, Montenegro-Pena M, Prada Crespo D, Rodriguez Rojo I, Barabash Bustelo A, Montejo Rubio B, Marcos Dolado A, Maestu Unturbe F, Delgado Losada ML. APOE genotype, hippocampal volume, and cognitive reserve predict improvement by cognitive training in older adults without dementia: a randomized controlled trial. Cogn Process. 2024 Nov;25(4):673-689. doi: 10.1007/s10339-024-01202-3. Epub 2024 Jun 19.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Multifactorial Memory Training Program (UMAM method) in people with Age-Related Memory Disorders, run by Madrid Salud at 1 site in Spain.
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 3 inclusion and 5 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 Jan 2020. 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 Spain. 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?
Change in general cognition (time frame: This cognitive variable was assessed before and after the intervention. The interval between the pre and post-intervention assessment was 6 months.). The study lists 16 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 NCT04245579, which also lists 1 linked publication.
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 Jan 2020.