Mild Cognitive ImpairmentCOPENCT04546451
Countervail Cognitive and Cerebral Decline in Mild Cognitive Impairment Patients Using Non-medical Interventions
A study testing Music practice and Psychomotor therapy in people with Mild Cognitive Impairment, run by School of Health Sciences Geneva at 2 sites in Switzerland.
Trial summary
Cognitive decline represents a major threat among the deleterious effects of population aging. The investigators propose to conduct an RCT (randomized controlled trial) on the subpopulation of MCI patients, and examine whether intensive musical or psychomotor group interventions can improve their cognitive and… Read more about this study
- Who is it for?
- Ages 60 to 80 years
- Conditions the study is for
- Mild Cognitive Impairment
- What is being tested?
- Music practice and Psychomotor therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 2 sitesSwitzerland
- Study dates
- 1 Jan 2021to 27 May 2023
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- MCI diagnosis by experts at the memory clinics
- MMSE score (Mini-Mental State Examination) > 22 or MoCA (Montreal Cognitive Assessment) > 18
- Hospital Anxiety and Depression Scale (HADS) < 14 (< 7/21 for anxiety and < 7/21 for depression)
- Age between 60 and 80 years
- Right-handedness
- Fluent in French
- Able to give informed consent as documented by signature
Who cannot join
- Serious motor deficits
- Impaired/not-corrected hearing
- Serious physical and mental comorbidities
- Participation in physical or cognitive training over the last 12 months
- Maximum 5 years of official music education over the lifespan outside the school curriculum or during the last 3 years
- Intensive physical activity over the last 12 months (sports or body-mind exercises)
Show all 9Show fewer
- Left-handed or ambidextrous
- MRI incompatibility (claustrophobia, cardiac stimulator, implants…)
- Nota bene: for brain organizational reasons exclusively right-handed participants will be included. Right-handed persons represent more than 90% of the population (Isaacs, Barr, Nelson, \& Devinsky, 2006., doi:10.1212/01.wnl.0000219623.28769.74.)
Trial locations and contacts
2 sites in 1 country.
Switzerland2 sites
School of Health Sciences Geneva HES-SO
Geneva, 1206
CHUV: Centre Leenaards Memory Center
Lausanne, Canton of Vaud, 1011
About this study
Official title: Musical and Psychomotor Interventions for Cognitive, Sensorimotor, and Cerebral Decline in Patients With Mild Cognitive Impairment (COPE): a Study Protocol for a Multicentric Randomized Controlled Study
Cognitive decline represents a major threat among the deleterious effects of population aging. The investigators propose to conduct an RCT (randomized controlled trial) on the subpopulation of MCI patients, and examine whether intensive musical or psychomotor group interventions can improve their cognitive and sensorimotor functioning, as well as induce brain plasticity, compared to a passive healthy control group, matched for age, gender and education level. The 2 training regimens will take place twice a week over 6 months and will be provided by professionals in each field.
Read the detailed description
Background Regular cognitive training can boost or maintain cognitive and brain functions known to decline with age. Most studies administered such cognitive training on a computer and in a lab setting. However, everyday life activities, like musical practice or physical exercise that are complex and variable, could be more successful at inducing transfer effects to different cognitive domains and maintaining motivation. "Body-mind exercises", like Tai Chi or psychomotor exercise, may also positively affect cognitive functioning in the elderly. We will investigate the influence of active music practice and psychomotor training over 6 months in Mild Cognitive Impairment patients from university hospital memory clinics on cognitive and sensorimotor performance and brain plasticity.
Methods We aim to conduct a randomized controlled (RCT) multicenter intervention study on 32 Mild Cognitive Impairment (MCI) patients (60-80 years), divided over 2 experimental groups: 1) Music practice; 2) Psychomotor treatment. Controls will consist of a passive test-retest group of 16 age, gender and education level matched healthy volunteers.
The training regimens take place twice a week for 45 minutes over 6 months in small groups, provided by professionals, and patients should exercise daily at home. Data collection takes place at baseline (before the interventions), 3, and 6 months after training onset, on cognitive and sensorimotor capacities, subjective well-being, daily living activities, and via functional and structural neuroimaging. Considering the current constraints of the ongoing COVID-19 (COronaVIrus Disease of 2019) pandemic, recruitment and data collection takes place in 2 waves.
Discussion We will investigate whether musical practice or psychomotor exercise in small groups can improve cognitive, sensorimotor and brain functioning in MCI patients, and therefore provoke benefits for their daily life functioning and well-being.
- Conditions
- Mild Cognitive Impairment
- Being tested
- Music practice, Psychomotor therapy
- Keywords
- Mild Cognitive Impairment, Randomized Controlled Trial, Non-medical interventions, Cognitive performance, Sensorimotor performance, Experience induced brain plasticity, Music Practice, Psychomotor training, Passive Control Group, Multivariate data-driven analyses
- Medical subject headings
- Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Music practiceBehavioural
Patients will be trained to play a simple instrument (tongue-drum) in a group setting using different musical styles.
Psychomotor therapyBehavioural
Patients will be trained in body awareness and a wide range of of movement activities.
| Study group | Role | What they receive |
|---|---|---|
| Music practice | Experimental | Patients will receive Music Practice interventions of 45 minutes twice a week over 6 months, provided by a professional musician Receives: Behavioral: Music practice |
| Psychomotor therapy | Experimental | Patients will receive Psychomotor interventions of 45 minutes twice a week over 6 months, provided by a professional psychomotor therapist Receives: Behavioral: Psychomotor therapy |
| Passive control group | No intervention | Healthy passive controls will pass all measurements without any intervention. The control group participants must adhere to the same inclusion and exclusion criteria as the experimental groups, except for an MCI diagnosis. Control participants will be matched to the experimental groups for age, gender and education level. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cognitive Telephone Screening Instrument (COGTEL)
This test can be applied by telephone or face-to-face (in this study we will apply the face-to-face method). The outcome consists of increase or less decrease (experimental group 1 or 2 vs. the control group) of the total weighted score at the COGTEL test directly after the 6 months interventions as compared to directly before the interventions.
The COGTEL test provides a main weighted score of core cognitive function, it comprises 6 subtests covering prospective memory, short- and long-term verbal memory, working memory (digit span), verbal fluency and inductive reasoning.
COGTEL main weighted score: COGTEL Total score = 7.2 x Prospective Memory score + 1.0 x Verbal Short-Term Memory score + 0.9 x Verbal Long-Term Memory score + 0.8 x Working Memory score + 0.2 x Verbal Fluency score + 1.7 x Inductive Reasoning score
(Kliegel, Martin, \& Jager, 2007, doi:10.3200/JRLP.141.2.147-172) (lhle et al., 2017, doi:10.1159/000479680)
Measured: 6 months
Secondary outcomes (14)
Individual subtests of the COGTEL (Cognitive Telephone Screening Instrument)
Individual subtests of the COGTEL: prospective memory, short- and long-term verbal memory, working memory (digit span), verbal fluency, and inductive reasoning; the outcome consists of increase or less decrease (experimental group 1 or 2 vs. the control group) of each subtest score directly after the 6 months interventions as compared to directly before the interventions.
Measured: 6 months
D2-R test
D2-R test (attention, processing speed): correct responses/hits minus errors/omissions; the outcome consists of increase or less decrease (experimental group 1 or 2 vs. the control group) of the total score directly after the 6 months interventions as compared to directly before the interventions.
Measured: 6 months
Trail making test
Trail making test A (visual processing speed) \& B (visual processing speed \& cognitive flexibility): time to complete the test A and B; the outcome consists in decrease or less increase in time to complete the tests (experimental group 1 or 2 vs. the control group) directly after the 6 months interventions as compared to directly before the interventions.
Measured: 6 months
Go/No-Go
Go/No-Go (inhibition): number of errors ; the outcome consists of decrease or less increase (experimental group 1 or 2 vs. the control group) of the total score directly after the 6 months interventions as compared to directly before the interventions.
Measured: 6 months
International Matrix Test (Oldenburg)
Speech-in-noise perception test. The outcome is a score of Speech Reception Threshold (SRT), measured for both ears and each ear separately (Kollmeier et al., 2105, doi: 10.3109/14992027.2015.1020971).
Measured: 6 months
fMRI visual working memory task
fMRI letter n-back visual working memory task (Migo et al., 2015, doi.org/10.1080/13825585.2014.894958): correct responses; the outcome consists of increase or less decrease (experimental group 1 or 2 vs. the control group) of the total score directly after the 6 months interventions as compared to directly before the interventions.
Measured: 6 months
Sensorimotor function
Higher total score of the following sensorimotor tests in the 2 experimental intervention groups as compared to the active control group directly after the 6 months interventions as compared to directly before the interventions.
- Clock drawing test (assessing apraxia) (Aprahamian, Martinelli, Neri, \& Yassuda, 2009, doi: 10.1590/S1980-57642009DN30200002)
- Purdue Pegboard (assessing manual dexterity) (Tiffin \& Asher, 1948, doi: 10.1037/h0061266)
- Unipedal balance test (Bohannon \& Tudini, 2018; doi:10.1016/j.physio.2018.04.001)
- Laterality test (assessing left/right judgements) (Williams et al., 2019, doi: 10.1016/j.msksp.2019.01.010)
Measured: 6 months
Short Version of the Amsterdam Instrumental Activity of the Daily Living Questionnaire (A-IADL-Q(SV))
Daily living activities: improved daily living activities as measured by the A-IADL-Q(SV; Short Version of the Amsterdam Instrumental Activity of the Daily Living Questionnaire) in the 2 experimental intervention groups as compared to the control group directly after the 6 months interventions as compared to directly before the interventions (Jutten et al., 2017, doi:10.1016/j.dadm.2017.03.002).
Measured: 6 months
World Health Organization Quality of Life Instruments - short Version WHOQOL-BREF (abbreviated World Health Organization Quality of Life; WHO 1996)
Subjective well-being: improved subjective well-being in both intervention groups as measured by the WHOQOL-BREF (1996) directly after the 6 months interventions as compared to directly before the interventions. (Organization, W. H. (1996). WHOQOL-BREF: introduction, administration, scoring and generic version of the assessment: field trial version, December 1996.)
Measured: 6 months
Emotional regulation questionnaire (ERQ)
Emotional regulation: improved emotional regulation in the experimental groups as compared to the control group directly after the 6 months interventions as compared to directly before the interventions (Christophe et al., 2009 doi: 10.1016/j.erap.2008.07.001).
Measured: 6 months
Magnetization Prepared 2 Rapid Gradient Echo (MP2RAGE)
MP2RAGE is an extension of the conventional MPRAGE pulse sequence widely used in clinical studies. It involves gray matter volume assessment, allowing to evaluate gray matter changes following learning of new skills (Marques \& Gruetter, 2013, doi:10.1371/journal.pone.0069294).
Measured: 6 months
Functional MRI (fMRI)
Letter N-back visual working memory task (Migo et al., 2015, doi.org/10.1080/13825585.2014.894958). Allows evaluating visual working memory performance following learning of new skills.
Measured: 6 months
Resting state functional MRI (RS-fMRI)
RS-fMRI assesses activity in the Default Mode Network (DMN) reflecting global functional connectivity of the brain (Leonardi et al., 2013, doi: 10.1016/j.neuroimage.2013.07.019). Allows evaluating functional connectivity changes following learning of new skills.
Measured: 6 months
Diffusion Tensor Imaging (DTI)
DTI allows computing i.a. Fractional Anisotropy for evaluating white matter integrity reflecting structural connectivity (Bosch et al., 2012, doi: 10.1016/j.neurobiolaging.2010.02.004). Allows evaluating structural connectivity changes following learning of new skills.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2020
- Study start1 Jan 2021
- Primary completion27 Mar 2023
- Study completion27 May 2023
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 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 2 experimental conditions (Music practice vs. Psychomotor training) and 1 passive control condition
- Masking
- None (open label)
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- School of Health Sciences Geneva
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital, Geneva, University of Geneva, Switzerland, University of Lausanne Hospitals
- Responsible party
- Sponsor
- Investigators
- Clara E. James, PhD, Principal investigator, University of Applied Sciences and Arts Western Switzerland, Geneva, Switzerland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04546451
- Sponsor's protocol ID
- 99861
- Acronym
- COPE
- Status last verified
- Nov 2022
- First submitted
- 29 Aug 2020
- Last updated
- 1 Jun 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: As soon as the data collection will be completed, all data and all other documents will be stored at YARETA, a FAIR (FAIR data are data which meet principles of findability, accessibility, interoperability, and reusability) digital solution for long-term preservation of research data for all Geneva Universities (https://yareta.unige.ch). The Geneva School of HEalth Sciences already possesses an organizational unit on the YARETA platform. The datasets generated during the current study will not publicly available during data collection and analyses. After data collection and analyses completion, they will be published by our research team first, but they will be available in the future from the corresponding author on reasonable request.
Publications
James CE, Stucker C, Junker-Tschopp C, Fernandes AM, Revol A, Mili ID, Kliegel M, Frisoni GB, Brioschi Guevara A, Marie D. Musical and psychomotor interventions for cognitive, sensorimotor, and cerebral decline in patients with Mild Cognitive Impairment (COPE): a study protocol for a multicentric randomized controlled study. BMC Geriatr. 2023 Feb 6;23(1):76. doi: 10.1186/s12877-022-03678-0.
PubMed 36747142
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Musical and Psychomotor Interventions for Cognitive, Sensorimotor, and Cerebral Decline in Patients With Mild Cognitive Impairment (COPE): a Study Protocol for a Multicentric Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT04546451
- Acronym / sponsor ID
- COPE / 99861
- Conditions
- Mild Cognitive Impairment
- Keywords
- Mild Cognitive Impairment, Randomized Controlled Trial, Non-medical interventions, Cognitive performance, Sensorimotor performance, Experience induced brain plasticity, Music Practice, Psychomotor training
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- School of Health Sciences GenevaUniversity, hospital or other
- Collaborators
- University Hospital, Geneva, University of Geneva, Switzerland, University of Lausanne Hospitals
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 27 Mar 2023 (actual)
- Study completion
- 27 May 2023 (actual)
- First posted
- 14 Sep 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.
Cognitive decline represents a major threat among the deleterious effects of population aging. The investigators propose to conduct an RCT (randomized controlled trial) on the subpopulation of MCI patients, and examine whether intensive musical or psychomotor group interventions can improve their cognitive and sensorimotor functioning, as well as induce brain plasticity, compared to a passive healthy control group, matched for age, gender and education level. The 2 training regimens will take place twice a week over 6 months and will be provided by professionals in each field.
Detailed description
Background Regular cognitive training can boost or maintain cognitive and brain functions known to decline with age. Most studies administered such cognitive training on a computer and in a lab setting. However, everyday life activities, like musical practice or physical exercise that are complex and variable, could be more successful at inducing transfer effects to different cognitive domains and maintaining motivation. "Body-mind exercises", like Tai Chi or psychomotor exercise, may also positively affect cognitive functioning in the elderly. We will investigate the influence of active music practice and psychomotor training over 6 months in Mild Cognitive Impairment patients from university hospital memory clinics on cognitive and sensorimotor performance and brain plasticity.
Methods We aim to conduct a randomized controlled (RCT) multicenter intervention study on 32 Mild Cognitive Impairment (MCI) patients (60-80 years), divided over 2 experimental groups: 1) Music practice; 2) Psychomotor treatment. Controls will consist of a passive test-retest group of 16 age, gender and education level matched healthy volunteers.
The training regimens take place twice a week for 45 minutes over 6 months in small groups, provided by professionals, and patients should exercise daily at home. Data collection takes place at baseline (before the interventions), 3, and 6 months after training onset, on cognitive and sensorimotor capacities, subjective well-being, daily living activities, and via functional and structural neuroimaging. Considering the current constraints of the ongoing COVID-19 (COronaVIrus Disease of 2019) pandemic, recruitment and data collection takes place in 2 waves.
Discussion We will investigate whether musical practice or psychomotor exercise in small groups can improve cognitive, sensorimotor and brain functioning in MCI patients, and therefore provoke benefits for their daily life functioning and well-being.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- 2 experimental conditions (Music practice vs. Psychomotor training) and 1 passive control condition
| Arm | Type | Receives |
|---|---|---|
| Music practice | Experimental | Behavioral: Music practicePatients will receive Music Practice interventions of 45 minutes twice a week over 6 months, provided by a professional musician |
| Psychomotor therapy | Experimental | Behavioral: Psychomotor therapyPatients will receive Psychomotor interventions of 45 minutes twice a week over 6 months, provided by a professional psychomotor therapist |
| Passive control group | No intervention | –Healthy passive controls will pass all measurements without any intervention. The control group participants must adhere to the same inclusion and exclusion criteria as the experimental groups, except for an MCI diagnosis. Control participants will be matched to the experimental groups for age, gender and education level. |
Who may qualify
- Ages
- 60 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- MCI diagnosis by experts at the memory clinics
- MMSE score (Mini-Mental State Examination) > 22 or MoCA (Montreal Cognitive Assessment) > 18
- Hospital Anxiety and Depression Scale (HADS) < 14 (< 7/21 for anxiety and < 7/21 for depression)
- Age between 60 and 80 years
- Right-handedness
Key exclusion criteria (9 listed)
- Serious motor deficits
- Impaired/not-corrected hearing
- Serious physical and mental comorbidities
- Participation in physical or cognitive training over the last 12 months
- Maximum 5 years of official music education over the lifespan outside the school curriculum or during the last 3 years
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 |
|---|---|---|
| Music practicePatients will be trained to play a simple instrument (tongue-drum) in a group setting using different musical styles. | Behavioural | Music practice |
| Psychomotor therapyPatients will be trained in body awareness and a wide range of of movement activities. | Behavioural | Psychomotor therapy |
Primary outcome
Cognitive Telephone Screening Instrument (COGTEL)
Time frame: 6 months
This test can be applied by telephone or face-to-face (in this study we will apply the face-to-face method). The outcome consists of increase or less decrease (experimental group 1 or 2 vs. the control group) of the total weighted score at the COGTEL test directly after the 6 months interventions as compared to directly before the interventions. The COGTEL test provides a main weighted score of core cognitive function, it comprises 6 subtests covering prospective memory, short- and long-term verbal memory, working memory (digit span), verbal fluency and inductive reasoning. COGTEL main weighted score: COGTEL Total score = 7.2 x Prospective Memory score + 1.0 x Verbal Short-Term Memory score + 0.9 x Verbal Long-Term Memory score + 0.8 x Working Memory score + 0.2 x Verbal Fluency score + 1.7 x Inductive Reasoning score (Kliegel, Martin, \& Jager, 2007, doi:10.3200/JRLP.141.2.147-172) (lhle et al., 2017, doi:10.1159/000479680)
14 secondary outcomes
Individual subtests of the COGTEL (Cognitive Telephone Screening Instrument)
Time frame: 6 months
D2-R test
Time frame: 6 months
Trail making test
Time frame: 6 months
Go/No-Go
Time frame: 6 months
International Matrix Test (Oldenburg)
Time frame: 6 months
fMRI visual working memory task
Time frame: 6 months
Sensorimotor function
Time frame: 6 months
Short Version of the Amsterdam Instrumental Activity of the Daily Living Questionnaire (A-IADL-Q(SV))
Time frame: 6 months
World Health Organization Quality of Life Instruments - short Version WHOQOL-BREF (abbreviated World Health Organization Quality of Life; WHO 1996)
Time frame: 6 months
Emotional regulation questionnaire (ERQ)
Time frame: 6 months
Magnetization Prepared 2 Rapid Gradient Echo (MP2RAGE)
Time frame: 6 months
Functional MRI (fMRI)
Time frame: 6 months
Resting state functional MRI (RS-fMRI)
Time frame: 6 months
Diffusion Tensor Imaging (DTI)
Time frame: 6 months
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 1 Jun 2023.
- Derived from this study: PubMed 36747142James CE, Stucker C, Junker-Tschopp C, Fernandes AM, Revol A, Mili ID, Kliegel M, Frisoni GB, Brioschi Guevara A, Marie D. Musical and psychomotor interventions for cognitive, sensorimotor, and cerebral decline in patients with Mild Cognitive Impairment (COPE): a study protocol for a multicentric randomized controlled study. BMC Geriatr. 2023 Feb 6;23(1):76. doi: 10.1186/s12877-022-03678-0.
- Individual participant dataSharing planned: Yes. As soon as the data collection will be completed, all data and all other documents will be stored at YARETA, a FAIR (FAIR data are data which meet principles of findability, accessibility, interoperability, and reusability) digital solution for long-term preservation of research data for all Geneva Universities (https://yareta.unige.ch). The Geneva School of HEalth Sciences already possesses an organizational unit on the YARETA platform. The datasets generated during the current study will not publicly available during data collection and analyses. After data collection and analyses completion, they will be published by our research team first, but they will be available in the future from the corresponding author on reasonable request.
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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.
Clara E. James, PhD principal investigator
University of Applied Sciences and Arts Western Switzerland, Geneva, Switzerland
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Music practice and Psychomotor therapy in people with Mild Cognitive Impairment, run by School of Health Sciences Geneva at 2 sites in Switzerland.
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 7 inclusion and 9 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 1 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Switzerland. 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?
Cognitive Telephone Screening Instrument (COGTEL) (time frame: 6 months). 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 NCT04546451, 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 1 Jun 2023.