AgingCOSMOS-WebNCT04582617
Investigating the Effects of Cocoa Flavanol on Cognition Assessed Online
A study testing Cocoa Extract and Multivitamin in people with Aging and Cognitive Change, run by Columbia University at 2 sites in United States.
Trial summary
The COcoa Supplement and Multivitamin Outcomes Study (COSMOS; NCT02422745) is a randomized clinical trial of cocoa extract supplement (containing a total of 500 mg/d flavanols, including 80 mg (-)-epicatechin), and/or a standard multivitamin supplement to reduce the risk of cardiovascular disease and cancer among men… Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Aging, Cognitive Change
- What is being tested?
- Cocoa Extract and Multivitamin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 3,959 participants
- Where
- 2 sitesUnited States
- Study dates
- 26 Aug 2016to 31 Dec 2020
- 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 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Willingness to participate
- Email and internet access via computer
Who cannot join
- Analog to COSMOS parent trial
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Brigham and Women's Hospital
Boston, Massachusetts, 02115
Columbia University Irving Medical Center
New York, New York, 10032
About this study
Official title: COSMOS Web: Investigating the Effects of Cocoa Flavanol on Cognition Assessed Online
The COcoa Supplement and Multivitamin Outcomes Study (COSMOS; NCT02422745) is a randomized clinical trial of cocoa extract supplement (containing a total of 500 mg/d flavanols, including 80 mg (-)-epicatechin), and/or a standard multivitamin supplement to reduce the risk of cardiovascular disease and cancer among men aged 60 years and older and women aged 65 years and older. This ancillary study (COSMOS Web) is being conducted among a subset of participants in COSMOS and will examine whether the cocoa extract supplements affects cognitive function in older adults.
Read the detailed description
The goal of the COSMOS Web study is to determine whether a dietary intervention with flavanol-containing cocoa extract has an effect on cognitive function in older adults (age 60+). The study will be conducted in a subset of 4000 participants from the COSMOS study (NCT02422745). The investigators' recent work (Sloan et al., submitted) showed that cocoa flavanol consumption over 12 weeks led to improvements in immediate recall on the ModRey verbal memory task in healthy older adults.
In COSMOS Web, the investigators are testing the effect of a dietary intervention with flavanol-containing cocoa extract on a range of aging-related cognitive measures, as assessed through a novel online-administered test battery, in a cohort of older participants. Change in ModRey (Modified Rey Auditory Verbal Learning Test) immediate recall performance over 1 year of cocoa extract consumption will be our primary outcome measure. Secondary endpoints will include change in ModRey performance at 2- and 3-year follow-up, and change in performance tests of a novel object recognition task, executive function/working memory, and spatial memory at 1-, 2-, and 3- years follow-up. This study will explore whether baseline measures of cognition and nutritional status can predict differential effects of the cocoa extract supplementation. This study will also explore the effect of multivitamin intake on the primary and secondary outcomes noted above and test whether multivitamin intake interacts with flavanol intake from cocoa extract to enhance or mitigate effects on cognitive outcomes. In a subset of participants evaluated in person, this study will examine the impact of cocoa extract intake and explore the main and interacting effects of multivitamins on cognitive changes and brain structure and function appreciated with magnetic resonance imaging over a 2-year period.
Leveraging the COSMOS study, which has randomized 21,442 older adult participants into cocoa extract and placebo interventions, the study team at Brigham and Women's Hospital, who administer the parent COSMOS trial, are recruiting ~4000 older adult volunteers to participate in COSMOS Web (this study) an online cognitive testing battery developed by the team at Columbia University. These 4000 participants will complete an initial online cognitive assessment and additional assessments after one, two, and three years of follow-up. In addition, approximately 200 COSMOS Web participants who live in the Boston area will complete clinic-based study visits at the Clinical and Translational Science Center at Brigham and Women's Hospital. During that visit, they will complete a neuropsychological test battery, for comparison to their performance online. This study will examine the impact of dietary interventions with cocoa extract and explore the main and interacting effects of multivitamin intake on cognitive changes and brain structure and function appreciated with magnetic resonance imaging over a 2-year period.
After the COSMOS trial began, an advanced method to analyze cocoa flavanols was accredited by AOAC International as a First Action Official Method of Analysis (https://doi.org/10.1093/jaoacint/qsaa132). This updated method relies on a reference material (RM8403) recently standardized and made commercially available by the U.S. National Institute of Standards and Technology. While the actual cocoa flavanol content of the COSMOS intervention remained unchanged throughout the trial, the application of this new analytical method led to expected changes in how the total cocoa flavanol content is now reported. Applying AOAC 2020.05/RM8403 to the COSMOS intervention, the total cocoa flavanol content of the COSMOS intervention is now 500 mg/day. Reporting of (-)-epicatechin content remained unaffected. Going forward, we will therefore apply AOAC 2020.05/RM8403 and report that the COSMOS intervention tested 500 mg/day of cocoa flavanols, including 80 mg of (-)-epicatechin.
- Conditions
- Aging, Cognitive Change
- Being tested
- Cocoa Extract, Cocoa Extract Placebo, Multivitamin, Multivitamin placebo
- Keywords
- Cognitive Function, Cognitive Change, Aging, ModRey, Cocoa Extract, Multivitamin, Hippocampus, Executive Function, Verbal Memory, Spatial Memory
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cocoa ExtractDietary supplement
2 capsules each day containing a total of 500 mg cocoa flavanols, including 80 mg (-)-epicatechin, and 50 mg theobromine
Cocoa Extract PlaceboDietary supplement
Cocoa extract placebo
MultivitaminDietary supplement
Multivitamin
Multivitamin placeboDietary supplement
Multivitamin placebo
| Study group | Role | What they receive |
|---|---|---|
| Cocoa extract + multivitamin | Active comparator | Not described Receives: Dietary Supplement: Cocoa Extract; Dietary Supplement: Multivitamin |
| Cocoa extract + multivitamin placebo | Active comparator | Not described Receives: Dietary Supplement: Cocoa Extract; Dietary Supplement: Multivitamin placebo |
| Cocoa extract placebo + multivitamin | Active comparator | Not described Receives: Dietary Supplement: Cocoa Extract Placebo; Dietary Supplement: Multivitamin |
| Cocoa extract placebo + multivitamin placebo | Placebo comparator | Not described Receives: Dietary Supplement: Cocoa Extract Placebo; Dietary Supplement: Multivitamin placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
ModRey: 1-Year Change in Immediate Recall/Learning/Episodic Memory
A measure of verbal memory. The change in the number of words recalled immediately on the ModRey task (Hale et al., 2019), after one year of cocoa extract/placebo intervention.
Measured: 1-year follow-up
Secondary outcomes (11)
ModRey: Longitudinal Change in Immediate Recall/Learning
A measure of verbal memory. Change in number of words recalled immediately on the ModRey task.
Measured: 2-year and 3-year follow-ups
ModBent
A measure of pattern separation/object recognition. Change in the mean response time on correct rejection trials on a delayed recognition task.
Measured: 1-year, 2-year and 3-year follow-ups
Flanker: Directional Flanker Effect
A measure of executive control. Change in the difference in reaction time (in ms) between directionally congruent and directional incongruent trials in a Flanker task.
Measured: 1-year, 2-year and 3-year follow-ups
Spatial Reconstruction: Distortion
A measure of spatial memory. Change in the proportion of stimulus pairs where their relative locations are reconstructed differently than originally shown
Measured: 1-year, 2-year and 3-year follow-ups
Self-Reported Memory Change
Self-report of memory change in the last year, on a scale of 1-7
Measured: 1-year, 2-year and 3-year follow-ups
In-clinic ModBent
Change in performance on the ModBent task, administered in-clinic to a subset of 200 participants
Measured: 2-year follow-up
Interaction of Baseline Diet & Intervention on the ModRey
Interaction of baseline diet (as assessed by the Food Frequency Questionnaire) with the flavanol/multivitamin interventions on the ModRey, a measure of verbal memory (change in number of words recalled)
Measured: 1-year, 2-year and 3-year follow-ups
Hippocampal volume change
Change in hippocampus volume (in cubic mm) in subset of participants with in-clinic MRI scan
Measured: 2-year follow-up
Global cortical thickness change
Change in average cortical thickness in the whole brain (in mm) in subset of participants with in-clinic MRI scan
Measured: 2-year follow-up
Hippocampal cerebral blood volume change
Change in cerebral blood volume in the hippocampus (in cubic mm) in subset of participants with in-clinic MRI scan
Measured: 2-year follow-up
Proportions of words recalled on in-clinic list learning task
Proportions of words recalled on list learning task for subset of participants with in-clinic cognitive testing
Measured: 2-year follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2020
- Study start26 Aug 2016
- Primary completion31 Dec 2020
- Study completion31 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for AgingStudies of the same condition, open and under way.
- More trials run by Columbia UniversityThe sponsor's other registered studies.
- 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
- Factorial
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 3,959 participants (actual)
Sponsor and investigators
- Lead sponsor
- Columbia University
- Sponsor type
- University, hospital or other
- Collaborators
- Brigham and Women's Hospital, Fred Hutchinson Cancer Center, Mars, Inc.
- Responsible party
- Sponsor
- Investigators
- Adam M. Brickman, PhD, Principal investigator, Columbia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04582617
- Sponsor's protocol ID
- AAAQ8029
- Acronym
- COSMOS-Web
- Status last verified
- Apr 2023
- First submitted
- 2 Oct 2019
- Last updated
- 7 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Researchers interested in study data may contact the study principal investigators to request access. Data requests must be submitted in writing for approval by qualified individuals; they will be reviewed by study investigators. External investigators who are granted access to data for analysis must identify a Cosmos Web investigator, who will participate in analyses and manuscript preparation as a co-author. Researchers interested in accessing data related to the Cosmos parent trial (NCT02422745) should contact the administrators of that study.
Publications
Brickman AM, Khan UA, Provenzano FA, Yeung LK, Suzuki W, Schroeter H, Wall M, Sloan RP, Small SA. Enhancing dentate gyrus function with dietary flavanols improves cognition in older adults. Nat Neurosci. 2014 Dec;17(12):1798-803. doi: 10.1038/nn.3850. Epub 2014 Oct 26.
PubMed 25344629Hale C, Last BS, Meier IB, Yeung LK, Budge M, Sloan RP, Small SA, Brickman AM. The ModRey: An Episodic Memory Test for Nonclinical and Preclinical Populations. Assessment. 2019 Sep;26(6):1154-1161. doi: 10.1177/1073191117723113. Epub 2017 Aug 11.
PubMed 28799411Sloan RP, Wall M, Yeung LK, Feng T, Feng X, Provenzano F, Schroeter H, Lauriola V, Brickman AM, Small SA. Insights into the role of diet and dietary flavanols in cognitive aging: results of a randomized controlled trial. Sci Rep. 2021 Feb 15;11(1):3837. doi: 10.1038/s41598-021-83370-2.
PubMed 33589674Vyas CM, Manson JE, Sesso HD, Cook NR, Rist PM, Weinberg A, Moorthy MV, Baker LD, Espeland MA, Yeung LK, Brickman AM, Okereke OI. Effect of multivitamin-mineral supplementation versus placebo on cognitive function: results from the clinic subcohort of the COcoa Supplement and Multivitamin Outcomes Study (COSMOS) randomized clinical trial and meta-analysis of 3 cognitive studies within COSMOS. Am J Clin Nutr. 2024 Mar;119(3):692-701. doi: 10.1016/j.ajcnut.2023.12.011. Epub 2024 Jan 18.
PubMed 38244989Yeung LK, Alschuler DM, Wall M, Luttmann-Gibson H, Copeland T, Hale C, Sloan RP, Sesso HD, Manson JE, Brickman AM. Multivitamin Supplementation Improves Memory in Older Adults: A Randomized Clinical Trial. Am J Clin Nutr. 2023 Jul;118(1):273-282. doi: 10.1016/j.ajcnut.2023.05.011. Epub 2023 May 24.
PubMed 37244291
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- COSMOS Web: Investigating the Effects of Cocoa Flavanol on Cognition Assessed Online
- ClinicalTrials.gov ID
- NCT04582617
- Acronym / sponsor ID
- COSMOS-Web / AAAQ8029
- Conditions
- Aging, Cognitive Change
- Keywords
- Cognitive Function, Cognitive Change, Aging, ModRey, Cocoa Extract, Multivitamin, Hippocampus, Executive Function
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 3,959 participants (actual)
- Lead sponsor
- Columbia UniversityUniversity, hospital or other
- Collaborators
- Brigham and Women's Hospital, Fred Hutchinson Cancer Center, Mars, Inc.
- Study start
- 26 Aug 2016 (actual)
- Primary completion
- 31 Dec 2020 (actual)
- Study completion
- 31 Dec 2020 (actual)
- First posted
- 9 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.
The COcoa Supplement and Multivitamin Outcomes Study (COSMOS; NCT02422745) is a randomized clinical trial of cocoa extract supplement (containing a total of 500 mg/d flavanols, including 80 mg (-)-epicatechin), and/or a standard multivitamin supplement to reduce the risk of cardiovascular disease and cancer among men aged 60 years and older and women aged 65 years and older. This ancillary study (COSMOS Web) is being conducted among a subset of participants in COSMOS and will examine whether the cocoa extract supplements affects cognitive function in older adults.
Detailed description
The goal of the COSMOS Web study is to determine whether a dietary intervention with flavanol-containing cocoa extract has an effect on cognitive function in older adults (age 60+). The study will be conducted in a subset of 4000 participants from the COSMOS study (NCT02422745). The investigators' recent work (Sloan et al., submitted) showed that cocoa flavanol consumption over 12 weeks led to improvements in immediate recall on the ModRey verbal memory task in healthy older adults.
In COSMOS Web, the investigators are testing the effect of a dietary intervention with flavanol-containing cocoa extract on a range of aging-related cognitive measures, as assessed through a novel online-administered test battery, in a cohort of older participants. Change in ModRey (Modified Rey Auditory Verbal Learning Test) immediate recall performance over 1 year of cocoa extract consumption will be our primary outcome measure. Secondary endpoints will include change in ModRey performance at 2- and 3-year follow-up, and change in performance tests of a novel object recognition task, executive function/working memory, and spatial memory at 1-, 2-, and 3- years follow-up. This study will explore whether baseline measures of cognition and nutritional status can predict differential effects of the cocoa extract supplementation. This study will also explore the effect of multivitamin intake on the primary and secondary outcomes noted above and test whether multivitamin intake interacts with flavanol intake from cocoa extract to enhance or mitigate effects on cognitive outcomes. In a subset of participants evaluated in person, this study will examine the impact of cocoa extract intake and explore the main and interacting effects of multivitamins on cognitive changes and brain structure and function appreciated with magnetic resonance imaging over a 2-year period.
Leveraging the COSMOS study, which has randomized 21,442 older adult participants into cocoa extract and placebo interventions, the study team at Brigham and Women's Hospital, who administer the parent COSMOS trial, are recruiting ~4000 older adult volunteers to participate in COSMOS Web (this study) an online cognitive testing battery developed by the team at Columbia University. These 4000 participants will complete an initial online cognitive assessment and additional assessments after one, two, and three years of follow-up. In addition, approximately 200 COSMOS Web participants who live in the Boston area will complete clinic-based study visits at the Clinical and Translational Science Center at Brigham and Women's Hospital. During that visit, they will complete a neuropsychological test battery, for comparison to their performance online. This study will examine the impact of dietary interventions with cocoa extract and explore the main and interacting effects of multivitamin intake on cognitive changes and brain structure and function appreciated with magnetic resonance imaging over a 2-year period.
After the COSMOS trial began, an advanced method to analyze cocoa flavanols was accredited by AOAC International as a First Action Official Method of Analysis (https://doi.org/10.1093/jaoacint/qsaa132). This updated method relies on a reference material (RM8403) recently standardized and made commercially available by the U.S. National Institute of Standards and Technology. While the actual cocoa flavanol content of the COSMOS intervention remained unchanged throughout the trial, the application of this new analytical method led to expected changes in how the total cocoa flavanol content is now reported. Applying AOAC 2020.05/RM8403 to the COSMOS intervention, the total cocoa flavanol content of the COSMOS intervention is now 500 mg/day. Reporting of (-)-epicatechin content remained unaffected. Going forward, we will therefore apply AOAC 2020.05/RM8403 and report that the COSMOS intervention tested 500 mg/day of cocoa flavanols, including 80 mg of (-)-epicatechin.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Cocoa extract + multivitamin | Active comparator | Dietary Supplement: Cocoa Extract, Dietary Supplement: Multivitamin |
| Cocoa extract + multivitamin placebo | Active comparator | Dietary Supplement: Cocoa Extract, Dietary Supplement: Multivitamin placebo |
| Cocoa extract placebo + multivitamin | Active comparator | Dietary Supplement: Cocoa Extract Placebo, Dietary Supplement: Multivitamin |
| Cocoa extract placebo + multivitamin placebo | Placebo comparator | Dietary Supplement: Cocoa Extract Placebo, Dietary Supplement: Multivitamin placebo |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (2 listed)
- Willingness to participate
- Email and internet access via computer
Key exclusion criteria (1 listed)
- Analog to COSMOS parent trial
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 |
|---|---|---|
| Cocoa Extract2 capsules each day containing a total of 500 mg cocoa flavanols, including 80 mg (-)-epicatechin, and 50 mg theobromine | Dietary supplement | Cocoa extract + multivitamin, Cocoa extract + multivitamin placebo |
| Cocoa Extract PlaceboCocoa extract placebo | Dietary supplement | Cocoa extract placebo + multivitamin, Cocoa extract placebo + multivitamin placebo |
| MultivitaminMultivitamin | Dietary supplement | Cocoa extract + multivitamin, Cocoa extract placebo + multivitamin |
| Multivitamin placeboMultivitamin placebo | Dietary supplement | Cocoa extract + multivitamin placebo, Cocoa extract placebo + multivitamin placebo |
Primary outcome
ModRey: 1-Year Change in Immediate Recall/Learning/Episodic Memory
Time frame: 1-year follow-up
A measure of verbal memory. The change in the number of words recalled immediately on the ModRey task (Hale et al., 2019), after one year of cocoa extract/placebo intervention.
11 secondary outcomes
ModRey: Longitudinal Change in Immediate Recall/Learning
Time frame: 2-year and 3-year follow-ups
ModBent
Time frame: 1-year, 2-year and 3-year follow-ups
Flanker: Directional Flanker Effect
Time frame: 1-year, 2-year and 3-year follow-ups
Spatial Reconstruction: Distortion
Time frame: 1-year, 2-year and 3-year follow-ups
Self-Reported Memory Change
Time frame: 1-year, 2-year and 3-year follow-ups
In-clinic ModBent
Time frame: 2-year follow-up
Interaction of Baseline Diet & Intervention on the ModRey
Time frame: 1-year, 2-year and 3-year follow-ups
Hippocampal volume change
Time frame: 2-year follow-up
Global cortical thickness change
Time frame: 2-year follow-up
Hippocampal cerebral blood volume change
Time frame: 2-year follow-up
Proportions of words recalled on in-clinic list learning task
Time frame: 2-year 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 7 Apr 2023.
- Background: PubMed 25344629Brickman AM, Khan UA, Provenzano FA, Yeung LK, Suzuki W, Schroeter H, Wall M, Sloan RP, Small SA. Enhancing dentate gyrus function with dietary flavanols improves cognition in older adults. Nat Neurosci. 2014 Dec;17(12):1798-803. doi: 10.1038/nn.3850. Epub 2014 Oct 26.
- Background: PubMed 28799411Hale C, Last BS, Meier IB, Yeung LK, Budge M, Sloan RP, Small SA, Brickman AM. The ModRey: An Episodic Memory Test for Nonclinical and Preclinical Populations. Assessment. 2019 Sep;26(6):1154-1161. doi: 10.1177/1073191117723113. Epub 2017 Aug 11.
- Background: PubMed 33589674Sloan RP, Wall M, Yeung LK, Feng T, Feng X, Provenzano F, Schroeter H, Lauriola V, Brickman AM, Small SA. Insights into the role of diet and dietary flavanols in cognitive aging: results of a randomized controlled trial. Sci Rep. 2021 Feb 15;11(1):3837. doi: 10.1038/s41598-021-83370-2.
- Derived from this study: PubMed 38244989Vyas CM, Manson JE, Sesso HD, Cook NR, Rist PM, Weinberg A, Moorthy MV, Baker LD, Espeland MA, Yeung LK, Brickman AM, Okereke OI. Effect of multivitamin-mineral supplementation versus placebo on cognitive function: results from the clinic subcohort of the COcoa Supplement and Multivitamin Outcomes Study (COSMOS) randomized clinical trial and meta-analysis of 3 cognitive studies within COSMOS. Am J Clin Nutr. 2024 Mar;119(3):692-701. doi: 10.1016/j.ajcnut.2023.12.011. Epub 2024 Jan 18.
- Derived from this study: PubMed 37244291Yeung LK, Alschuler DM, Wall M, Luttmann-Gibson H, Copeland T, Hale C, Sloan RP, Sesso HD, Manson JE, Brickman AM. Multivitamin Supplementation Improves Memory in Older Adults: A Randomized Clinical Trial. Am J Clin Nutr. 2023 Jul;118(1):273-282. doi: 10.1016/j.ajcnut.2023.05.011. Epub 2023 May 24.
- Individual participant dataSharing planned: Yes. Researchers interested in study data may contact the study principal investigators to request access. Data requests must be submitted in writing for approval by qualified individuals; they will be reviewed by study investigators. External investigators who are granted access to data for analysis must identify a Cosmos Web investigator, who will participate in analyses and manuscript preparation as a co-author. Researchers interested in accessing data related to the Cosmos parent trial (NCT02422745) should contact the administrators of that study.
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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.
Adam M. Brickman, PhD principal investigator
Columbia University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cocoa Extract and Multivitamin in people with Aging and Cognitive Change, run by Columbia University at 2 sites in United States.
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 2 inclusion and 1 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 7 Apr 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 United States. 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. Some participants in this study may receive a placebo. 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?
ModRey: 1-Year Change in Immediate Recall/Learning/Episodic Memory (time frame: 1-year follow-up). 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 NCT04582617, which also lists 5 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 7 Apr 2023.