Cognitive DeclineNCT04204239
Validation Study SCOBES-AR
An observational study of Cognitive Decline and Cognitive Deficit, run by FH Joanneum Gesellschaft mbH at 1 site in Austria.
Trial summary
Purpose of the study The purpose of this study is to evaluate five tests to see if they are suitable for the early detection of cognitive impairment in people over the age of 60. These test procedures record the movement pattern and gait pattern, the reaction time, so-called instrumental activities of daily life (e.g. Read more about this study
- Who is it for?
- Ages 60 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Cognitive Decline, Cognitive Deficit, Cognitive Impairment
- How many people
- 300 participants
- Where
- 1 siteAustria
- Study dates
- 7 Jan 2020to 30 Sep 2023
- Phase
- Observational
- 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 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Residents of the city of Graz and Graz suburbs
Who may be able to join
- Healthy individuals aged 60-75 years
- Interested in participating in the study
- Signing a written informed consent form
Who cannot join
- Persons who are not legally competent (Austrian adult protection law)
- Clinical diagnosis of dementia or MCI (Mild Cognitive Impairment)
- Clinical diagnosis of mental illness (e.g. depression or psychosis)
- Reduced mobility (sidekick, wheelchair)
- No compensation for visual or hearing impairment
- Insufficient knowledge of German
Trial locations and contacts
1 site in 1 country.
Austria1 site, 1 recruiting
- Recruiting
University of Applied Sciences, FH JOANNEUM
Graz, Styria, 8020
Wolfgang Staubmann, BSc MSc, 433165453 ext. 6768, wolfgang.staubmann@fh-joanneum.at
About this study
Official title: A Review of Test Procedures From Different Health Care Professions With Regard to Their Suitability for the Early Detection of Cognitive Impairments in Persons Aged 60 and Older: A Validation Study
Purpose of the study The purpose of this study is to evaluate five tests to see if they are suitable for the early detection of cognitive impairment in people over the age of 60. These test procedures record the movement pattern and gait pattern, the reaction time, so-called instrumental activities of daily life (e.g. shopping or preparing meals), nutritional behaviour and the relevant sense of smell. The results are compared with those of a diagnostic procedure already in use.
Read the detailed description
Improved living conditions and health care are making people in Austria older and older. However, OECD data show that this happens with a lower quality of life compared to other EU member states. One factor influencing the quality of life is individual functionality at the physical and cognitive levels. Physical functionality is obvious, but cognitive impairment is preceded by a long latency phase in which subtle limitations of executive functions exist. Studies have shown that early detection of dementia through screening and early intervention can make an important contribution to a favourable course of treatment. Measures of early detection and prevention for the prevention of clinical occurrence thus move into focus. Current clinical diagnostic procedures such as cerebrospinal fluid diagnostics and MRI are not suitable for population-based early detection. Augmented Reality (AR) techniques represent an innovative basis for the development of information and communication technology (ICT) based assessment procedures. Real objects are extended by means of smartphones with virtual objects and tasks as test objects of screening. Parallel measurements of multiple parameters, automatic action recording and semi-automated evaluations provide detailed results.
The project SCOBES-AR (Smart Cognition \& Behaviour Screening powered by Augmented Reality) is funded by the Austrian Research Promotion Agency (FFG) and has a maximum duration of five years (September 2023). Through the cooperation of various health science and technical study programmes (dietology, occupational therapy, health and nursing, health management in tourism/sports science laboratory, information management, speech therapy, physiotherapy) of FH JOANNEUM, a screening instrument for the early detection of neurocognitive deficits is to be developed. The aim is to establish a multimodal tool for sustainable use in the health care system. The project thus takes up the impact goals of the Austrian dementia strategy and aims to develop a multimodal screening instrument for the early detection of functional impairments (on a cognitive and physical level) in middle and old age for outpatient care. In Phase I of the project, the evidence base for a valid instrument will be developed - The focus is on assessment selection, data protection and implementation in an AR environment. The evaluation and validation of the prototype and the AR environment are carried out in phase I and phase II respectively. In Phase III, a business model for sustainable use in the health care system with possibilities in the big data area will be developed for the finalized instrument. The present study protocol only describes the validation study in phase I of the project.
- Research objectives in phase I of the project In order to realize the main goal of the project, to develop a multimodal and low-threshold screening instrument embedded in an AR environment for the early detection of functional limitations on cognitive for outpatient care, comprehensive preliminary investigations are necessary.
The validation study presented here is one of these preliminary investigations. Five test procedures are to be tested to determine whether they are suitable for the early detection of cognitive impairments in people aged 60 and over and thus whether the evidence base for a valid instrument can be established. Different functionalities such as movement pattern \& gait pattern, reaction time, instrumental activities of daily life (iADL) will be recorded and evaluated. Examples of iADLs are shopping, financial regulation, mobility or preparing meals. Nutritional behaviour is also evaluated, since, for example, adherence to a Mediterranean diet is associated with a lower risk of various age-related diseases, including dementia. Another possible predictive factor for the development of neurocognitive impairment is the decrease in olfactory performance, which is why olfactory performance is also measured. The collected data should be compared with the established test battery "Cognitive Functions Dementia" (CFD), which is widely used in neuropsychological practice, to clarify cognitive impairments and thus be validated. The combination of the collected data results in a comprehensive functional status picture of the tested persons. Due to the extensive test setting with different test items, SCOBES-AR offers a comprehensive view of the cognitive and physical functionalities of the test person. It allows the Focus on existing reserves and capacities of the test person and not on their deficits.
The results of the present validation study will be used at the end of the project to collect the above-mentioned - or similar - functionalities via assessments, which are partly implemented in an Augmented Reality environment.
- Primary hypothesis of the study The planned tests are suitable for the early detection of cognitive impairment in people over 60 years of age.
- Secondary hypotheses of the study The primary target group (people aged 60 and over) is interested in recognising functional (cognitive and physical) limitations at an early stage in order to be able to work specifically on improving them.
- Conditions
- Cognitive Decline, Cognitive Deficit, Cognitive Impairment
- Medical subject headings
- Cognitive Dysfunction, Cognition Disorders
What is being measured
The primary outcome is the main question the study is designed to answer.
Erlangen Test of Activities of daily living in Persons with Mild Dementia or Mild Cognitive impairment (ETAM)
For three Items the performance is evaluated on a seven-level scale (0-6 points). The execution of an item is subdivided into six sub-steps so that the test persons receive one point for each error-free sub-step. A four-step scale (0-3 points) was used for two items with a less complex structure (alarm clock and tea). The total value ranges from 0-30 points.
Measured: By completing the entire test set, an average of 2 hours
Brief Smell Identification Test (B-SIT)
The test person should recognize 12 different odorous substances and choose from a four-step multiple-choice question. A total odour score results from the number of correctly identified odours, whereby higher values stand for a better odour performance (>9 recognised odours).
Measured: By completing the entire test set, an average of 2 hours
Reaction test (TDS)
Eye to hand reaction, eye to leg reaction, complex reaction capability; the time required (seconds/milliseconds) for the completion is recorded.
Measured: By completing the entire test set, an average of 2 hours
Dual-Task-Assessment (DTA)
Measures the influence of a cognitive task on the gait pattern. Impaired subjects show a stronger change of different gait parameters. The gait speed, cadence, stride length, stride variance and gait phases are measured.
Measured: By completing the entire test set, an average of 2 hours
Mediterranean Diet Adherence Score (MEDAS)
14-Elements-Screeningtool for the evaluation of the adherence to the Mediterranean diet. The maximum score is 14 points and indicates full compliance with the Mediterranean diet.
Measured: By completing the entire test set, an average of 2 hours
Secondary outcomes (1)
Cognitive Functions Dementia (CFD)
A digital test set for the early diagnosis of dementia. It contains tests for verbal learning and memory skill, working memory, measurement of attention, cognitive flexibility, information processing speed, visuoconstruction, object naming and verbal fluency.
Measured: By completing the entire test set, an average of 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2019
- Study start7 Jan 2020
- Primary completion30 Sep 2023 (estimated)
- Study completion30 Sep 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Cognitive DeclineStudies 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- FH Joanneum Gesellschaft mbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Austrian Research Promotion Agency
- Responsible party
- Sponsor
- Investigators
- Wolfgang Staubmann, BSc MSc, Study director, University of Applied Sciences, FH JOANNEUM
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04204239
- Sponsor's protocol ID
- Validation study SCOBES-AR
- Status last verified
- Aug 2022
- First submitted
- 11 Dec 2019
- Last updated
- 9 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Hebestreit K, Yahiaoui-Doktor M, Engel C, Vetter W, Siniatchkin M, Erickson N, Halle M, Kiechle M, Bischoff SC. Validation of the German version of the Mediterranean Diet Adherence Screener (MEDAS) questionnaire. BMC Cancer. 2017 May 18;17(1):341. doi: 10.1186/s12885-017-3337-y.
PubMed 28521737American Occupational Therapy Association (Hrsg.). (2018). Das Framework der AOTA. Gegenstandsbereich, Prozesse und Kontexte in der ergotherapeutischen Praxis. Bern: Hogrefe.
Doty RL, Marcus A, Lee WW. Development of the 12-item Cross-Cultural Smell Identification Test (CC-SIT). Laryngoscope. 1996 Mar;106(3 Pt 1):353-6. doi: 10.1097/00005537-199603000-00021.
PubMed 8614203Hendry K, Quinn TJ, Evans JJ, Stott DJ. Informant single screening questions for delirium and dementia in acute care--a cross-sectional test accuracy pilot study. BMC Geriatr. 2015 Feb 25;15:17. doi: 10.1186/s12877-015-0016-1.
PubMed 25885022Hunter SW, Divine A, Frengopoulos C, Montero Odasso M. A framework for secondary cognitive and motor tasks in dual-task gait testing in people with mild cognitive impairment. BMC Geriatr. 2018 Sep 3;18(1):202. doi: 10.1186/s12877-018-0894-0.
PubMed 30176796Jahn, T. & Heßler, J. B. (2017). Handanweisung Kognitive Funktionen Demenz (Kurzbezeichung CFD). Mödling: Schufried GmbH
Juraszovich, B.; Sax, G.; Rappold, E.; Pfabigan, D. & Stewig, F. (Hg). (2015). Demenzstrategie Gut Leben mit Demenz. Wien: Bundesministerium für Gesundheit und Sozialministerium; 2015.
Kivipelto M, Solomon A, Ahtiluoto S, Ngandu T, Lehtisalo J, Antikainen R, Backman L, Hanninen T, Jula A, Laatikainen T, Lindstrom J, Mangialasche F, Nissinen A, Paajanen T, Pajala S, Peltonen M, Rauramaa R, Stigsdotter-Neely A, Strandberg T, Tuomilehto J, Soininen H. The Finnish Geriatric Intervention Study to Prevent Cognitive Impairment and Disability (FINGER): study design and progress. Alzheimers Dement. 2013 Nov;9(6):657-65. doi: 10.1016/j.jalz.2012.09.012. Epub 2013 Jan 17.
PubMed 23332672Lin KC, Wu YF, Chen IC, Tsai PL, Wu CY, Chen CL. Dual-task performance involving hand dexterity and cognitive tasks and daily functioning in people with schizophrenia: a pilot study. Am J Occup Ther. 2015 May-Jun;69(3):6903250020p1-7. doi: 10.5014/ajot.2014.014738.
PubMed 25871598Luttenberger K, Reppermund S, Schmiedeberg-Sohn A, Book S, Graessel E. Validation of the Erlangen Test of Activities of Daily Living in Persons with Mild Dementia or Mild Cognitive Impairment (ETAM). BMC Geriatr. 2016 May 26;16:111. doi: 10.1186/s12877-016-0271-9.
PubMed 27229937Lourida I, Soni M, Thompson-Coon J, Purandare N, Lang IA, Ukoumunne OC, Llewellyn DJ. Mediterranean diet, cognitive function, and dementia: a systematic review. Epidemiology. 2013 Jul;24(4):479-89. doi: 10.1097/EDE.0b013e3182944410.
PubMed 23680940Yahiaoui-Doktor M, Luck T, Riedel-Heller SG, Loeffler M, Wirkner K, Engel C. Olfactory function is associated with cognitive performance: results from the population-based LIFE-Adult-Study. Alzheimers Res Ther. 2019 May 10;11(1):43. doi: 10.1186/s13195-019-0494-z.
PubMed 31077241
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Review of Test Procedures From Different Health Care Professions With Regard to Their Suitability for the Early Detection of Cognitive Impairments in Persons Aged 60 and Older: A Validation Study
- ClinicalTrials.gov ID
- NCT04204239
- Acronym / sponsor ID
- Validation study SCOBES-AR
- Conditions
- Cognitive Decline, Cognitive Deficit, Cognitive Impairment
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- FH Joanneum Gesellschaft mbHIndustry (pharma, biotech, devices)
- Collaborators
- Austrian Research Promotion Agency
- Study start
- 7 Jan 2020 (actual)
- Primary completion
- 30 Sep 2023 (estimated)
- Study completion
- 30 Sep 2023 (estimated)
- First posted
- 18 Dec 2019 (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.
Purpose of the study The purpose of this study is to evaluate five tests to see if they are suitable for the early detection of cognitive impairment in people over the age of 60. These test procedures record the movement pattern and gait pattern, the reaction time, so-called instrumental activities of daily life (e.g. shopping or preparing meals), nutritional behaviour and the relevant sense of smell. The results are compared with those of a diagnostic procedure already in use.
Detailed description
Improved living conditions and health care are making people in Austria older and older. However, OECD data show that this happens with a lower quality of life compared to other EU member states. One factor influencing the quality of life is individual functionality at the physical and cognitive levels. Physical functionality is obvious, but cognitive impairment is preceded by a long latency phase in which subtle limitations of executive functions exist. Studies have shown that early detection of dementia through screening and early intervention can make an important contribution to a favourable course of treatment. Measures of early detection and prevention for the prevention of clinical occurrence thus move into focus. Current clinical diagnostic procedures such as cerebrospinal fluid diagnostics and MRI are not suitable for population-based early detection. Augmented Reality (AR) techniques represent an innovative basis for the development of information and communication technology (ICT) based assessment procedures. Real objects are extended by means of smartphones with virtual objects and tasks as test objects of screening. Parallel measurements of multiple parameters, automatic action recording and semi-automated evaluations provide detailed results.
The project SCOBES-AR (Smart Cognition \& Behaviour Screening powered by Augmented Reality) is funded by the Austrian Research Promotion Agency (FFG) and has a maximum duration of five years (September 2023). Through the cooperation of various health science and technical study programmes (dietology, occupational therapy, health and nursing, health management in tourism/sports science laboratory, information management, speech therapy, physiotherapy) of FH JOANNEUM, a screening instrument for the early detection of neurocognitive deficits is to be developed. The aim is to establish a multimodal tool for sustainable use in the health care system. The project thus takes up the impact goals of the Austrian dementia strategy and aims to develop a multimodal screening instrument for the early detection of functional impairments (on a cognitive and physical level) in middle and old age for outpatient care. In Phase I of the project, the evidence base for a valid instrument will be developed - The focus is on assessment selection, data protection and implementation in an AR environment. The evaluation and validation of the prototype and the AR environment are carried out in phase I and phase II respectively. In Phase III, a business model for sustainable use in the health care system with possibilities in the big data area will be developed for the finalized instrument. The present study protocol only describes the validation study in phase I of the project.
- Research objectives in phase I of the project In order to realize the main goal of the project, to develop a multimodal and low-threshold screening instrument embedded in an AR environment for the early detection of functional limitations on cognitive for outpatient care, comprehensive preliminary investigations are necessary.
The validation study presented here is one of these preliminary investigations. Five test procedures are to be tested to determine whether they are suitable for the early detection of cognitive impairments in people aged 60 and over and thus whether the evidence base for a valid instrument can be established. Different functionalities such as movement pattern \& gait pattern, reaction time, instrumental activities of daily life (iADL) will be recorded and evaluated. Examples of iADLs are shopping, financial regulation, mobility or preparing meals. Nutritional behaviour is also evaluated, since, for example, adherence to a Mediterranean diet is associated with a lower risk of various age-related diseases, including dementia. Another possible predictive factor for the development of neurocognitive impairment is the decrease in olfactory performance, which is why olfactory performance is also measured. The collected data should be compared with the established test battery "Cognitive Functions Dementia" (CFD), which is widely used in neuropsychological practice, to clarify cognitive impairments and thus be validated. The combination of the collected data results in a comprehensive functional status picture of the tested persons. Due to the extensive test setting with different test items, SCOBES-AR offers a comprehensive view of the cognitive and physical functionalities of the test person. It allows the Focus on existing reserves and capacities of the test person and not on their deficits.
The results of the present validation study will be used at the end of the project to collect the above-mentioned - or similar - functionalities via assessments, which are partly implemented in an Augmented Reality environment.
- Primary hypothesis of the study The planned tests are suitable for the early detection of cognitive impairment in people over 60 years of age.
- Secondary hypotheses of the study The primary target group (people aged 60 and over) is interested in recognising functional (cognitive and physical) limitations at an early stage in order to be able to work specifically on improving them.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 60 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Residents of the city of Graz and Graz suburbs
Key inclusion criteria (3 listed)
- Healthy individuals aged 60-75 years
- Interested in participating in the study
- Signing a written informed consent form
Key exclusion criteria (6 listed)
- Persons who are not legally competent (Austrian adult protection law)
- Clinical diagnosis of dementia or MCI (Mild Cognitive Impairment)
- Clinical diagnosis of mental illness (e.g. depression or psychosis)
- Reduced mobility (sidekick, wheelchair)
- No compensation for visual or hearing impairment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Erlangen Test of Activities of daily living in Persons with Mild Dementia or Mild Cognitive impairment (ETAM)
Time frame: By completing the entire test set, an average of 2 hours
For three Items the performance is evaluated on a seven-level scale (0-6 points). The execution of an item is subdivided into six sub-steps so that the test persons receive one point for each error-free sub-step. A four-step scale (0-3 points) was used for two items with a less complex structure (alarm clock and tea). The total value ranges from 0-30 points.
Brief Smell Identification Test (B-SIT)
Time frame: By completing the entire test set, an average of 2 hours
The test person should recognize 12 different odorous substances and choose from a four-step multiple-choice question. A total odour score results from the number of correctly identified odours, whereby higher values stand for a better odour performance (>9 recognised odours).
Reaction test (TDS)
Time frame: By completing the entire test set, an average of 2 hours
Eye to hand reaction, eye to leg reaction, complex reaction capability; the time required (seconds/milliseconds) for the completion is recorded.
Dual-Task-Assessment (DTA)
Time frame: By completing the entire test set, an average of 2 hours
Measures the influence of a cognitive task on the gait pattern. Impaired subjects show a stronger change of different gait parameters. The gait speed, cadence, stride length, stride variance and gait phases are measured.
Mediterranean Diet Adherence Score (MEDAS)
Time frame: By completing the entire test set, an average of 2 hours
14-Elements-Screeningtool for the evaluation of the adherence to the Mediterranean diet. The maximum score is 14 points and indicates full compliance with the Mediterranean diet.
1 secondary outcome
Cognitive Functions Dementia (CFD)
Time frame: By completing the entire test set, an average of 2 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2022.
- Background: PubMed 28521737Hebestreit K, Yahiaoui-Doktor M, Engel C, Vetter W, Siniatchkin M, Erickson N, Halle M, Kiechle M, Bischoff SC. Validation of the German version of the Mediterranean Diet Adherence Screener (MEDAS) questionnaire. BMC Cancer. 2017 May 18;17(1):341. doi: 10.1186/s12885-017-3337-y.
- BackgroundAmerican Occupational Therapy Association (Hrsg.). (2018). Das Framework der AOTA. Gegenstandsbereich, Prozesse und Kontexte in der ergotherapeutischen Praxis. Bern: Hogrefe.
- Background: PubMed 8614203Doty RL, Marcus A, Lee WW. Development of the 12-item Cross-Cultural Smell Identification Test (CC-SIT). Laryngoscope. 1996 Mar;106(3 Pt 1):353-6. doi: 10.1097/00005537-199603000-00021.
- Background: PubMed 25885022Hendry K, Quinn TJ, Evans JJ, Stott DJ. Informant single screening questions for delirium and dementia in acute care--a cross-sectional test accuracy pilot study. BMC Geriatr. 2015 Feb 25;15:17. doi: 10.1186/s12877-015-0016-1.
- Background: PubMed 30176796Hunter SW, Divine A, Frengopoulos C, Montero Odasso M. A framework for secondary cognitive and motor tasks in dual-task gait testing in people with mild cognitive impairment. BMC Geriatr. 2018 Sep 3;18(1):202. doi: 10.1186/s12877-018-0894-0.
- BackgroundJahn, T. & Heßler, J. B. (2017). Handanweisung Kognitive Funktionen Demenz (Kurzbezeichung CFD). Mödling: Schufried GmbH
- BackgroundJuraszovich, B.; Sax, G.; Rappold, E.; Pfabigan, D. & Stewig, F. (Hg). (2015). Demenzstrategie Gut Leben mit Demenz. Wien: Bundesministerium für Gesundheit und Sozialministerium; 2015.
- Background: PubMed 23332672Kivipelto M, Solomon A, Ahtiluoto S, Ngandu T, Lehtisalo J, Antikainen R, Backman L, Hanninen T, Jula A, Laatikainen T, Lindstrom J, Mangialasche F, Nissinen A, Paajanen T, Pajala S, Peltonen M, Rauramaa R, Stigsdotter-Neely A, Strandberg T, Tuomilehto J, Soininen H. The Finnish Geriatric Intervention Study to Prevent Cognitive Impairment and Disability (FINGER): study design and progress. Alzheimers Dement. 2013 Nov;9(6):657-65. doi: 10.1016/j.jalz.2012.09.012. Epub 2013 Jan 17.
- Background: PubMed 25871598Lin KC, Wu YF, Chen IC, Tsai PL, Wu CY, Chen CL. Dual-task performance involving hand dexterity and cognitive tasks and daily functioning in people with schizophrenia: a pilot study. Am J Occup Ther. 2015 May-Jun;69(3):6903250020p1-7. doi: 10.5014/ajot.2014.014738.
- Background: PubMed 27229937Luttenberger K, Reppermund S, Schmiedeberg-Sohn A, Book S, Graessel E. Validation of the Erlangen Test of Activities of Daily Living in Persons with Mild Dementia or Mild Cognitive Impairment (ETAM). BMC Geriatr. 2016 May 26;16:111. doi: 10.1186/s12877-016-0271-9.
- Background: PubMed 23680940Lourida I, Soni M, Thompson-Coon J, Purandare N, Lang IA, Ukoumunne OC, Llewellyn DJ. Mediterranean diet, cognitive function, and dementia: a systematic review. Epidemiology. 2013 Jul;24(4):479-89. doi: 10.1097/EDE.0b013e3182944410.
- Background: PubMed 31077241Yahiaoui-Doktor M, Luck T, Riedel-Heller SG, Loeffler M, Wirkner K, Engel C. Olfactory function is associated with cognitive performance: results from the population-based LIFE-Adult-Study. Alzheimers Res Ther. 2019 May 10;11(1):43. doi: 10.1186/s13195-019-0494-z.
- Individual participant dataSharing planned: No
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EFFECTS OF AN OUTDOOR MAT PILATES PROGRAM ON NEUROPHYSIOLOGICAL INDICATORS OF ELDERLY INDIVIDUALS WITH MILD COGNITIVE IMPAIRMENT
Cognition Disorders
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.
Wolfgang Staubmann, BSc MSc study director
University of Applied Sciences, FH JOANNEUM
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cognitive Decline and Cognitive Deficit, run by FH Joanneum Gesellschaft mbH at 1 site in Austria.
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 6 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: status not confirmed, as of the sponsor's last update on 9 Aug 2022. 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 Austria. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Monica Christova, PhD (+433165453 ext. 6552, monica.christova@fh-joanneum.at), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Erlangen Test of Activities of daily living in Persons with Mild Dementia or Mild Cognitive impairment (ETAM) (time frame: By completing the entire test set, an average of 2 hours). The study lists 5 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 NCT04204239, which also lists 12 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 9 Aug 2022.