Cognitive DeclineMAEVENCT06507254
Polyphenols and Cognitive Decline
A study testing Polyphenol Supplement in people with Cognitive Decline and Cognitive Dysfunction, run by University of California, Los Angeles at 1 site in United States.
Trial summary
Globally, populations are aging thereby increasing healthcare burden, overall cognitive impairment, and dementia including Alzheimers diseases (AD). The lack of effective treatments makes it essential to develop new strategies for healthy cognitive aging, including interventions to slow or prevent cognitive decline. Read more about this study
- Who is it for?
- Ages 50 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cognitive Decline, Cognitive Dysfunction
- What is being tested?
- Polyphenol Supplement
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 300 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Jan 2025to 31 Dec 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 50 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 50+ Years of age
- Male or Female
- At enhanced risk of Alzheimer's Disease (defined as family history of AD, 1st degree family member)
- Habitually consume suboptimal diets such as typical Western Diet (i.e., high in animal products, refined carbohydrates and processed food)
- Able to communicate well in English
Who cannot join
- Vegan or Vegetarian
- Presence of cognitive impairment at the time of recruitment into the study as measured by the Mini Mental Status Exam (MMSE, score 25-30) and Clinical Dementia Rating (CDR, score=0).
- Pre-existing psychosis or psychiatric conditions
- Currently receiving treatment for dementia
- History of alcohol and/or substance abuse/dependence as determined by a positive endorsement on the MINI+/ If the MINI+ is positive for alcohol or drug dependence, or abuse, the participants will be excluded.
- Heavy use of tobacco (greater than 1/2 pack per day)
Show all 16Show fewer
- History of cerebrovascular events
- Existing allergies to berry fruits
- Use of oral/IV antibiotics in the last 3 months. Use of probiotics in the last 1 month.
- Recent Changes (last 3 months) in the use of psychoactive medications or other medications that interfere with the measured outcomes.
- Frailty, malnutrition, or food allergy/intolerance requiring special diets.
- Body weight at enrollment greater than 400lbs due to weight restrictions on the MRI table.
- Women who are pregnant, lactating, or postpartum for less than 6months.
- Women of childbearing age who are not practicing birth control or are planning to get pregnant during the study.
- Unable to safely participate in the MRI (claustrophobia, presence of devices affected by MRI such as pacemakers, neurostimulators, metallic foreign body, etc.)
- Chronic Pain
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of California, Los Angeles
Los Angeles, California, 90095
Marika Dy, MPH, 3102670089, ChurchLab@mednet.ucla.edu
Arpana Church, PhD
About this study
Official title: MAEVE: Microbiota Mediated Flavonoid Metabolites for Cognitive Health
Globally, populations are aging thereby increasing healthcare burden, overall cognitive impairment, and dementia including Alzheimers diseases (AD). The lack of effective treatments makes it essential to develop new strategies for healthy cognitive aging, including interventions to slow or prevent cognitive decline. A traditional Mediterranean diet, rich in polyphenols (PPs), may prevent or delay the onset of cognitive dysfunction in older adults, preserving healthy brain structure and function, and lowering the risk of AD. These effects, mediated in part by gut microbiome-derived PP metabolites, highlight the role alterations in the brain-gut microbiome system play in neurodegeneration. Moreover, high levels of circulating phenyl-y-valerolactones, neuroprotective compounds, exclusively produced by gut microbiota from flavan-3-ol-rich foods (e.g., cocoa, tea, berries) are associated with delaying the onset of cognitive dysfunction in older adults. Intake of such PPs can also change gut microbial composition and function, altering the physiology of the hosts secondary bile acid (BA) pool, affecting regulatory and signaling functions in the brain as well as cognitive decline and AD. The investigators hypothesize that, in older adults with enhanced AD risk, dietary intake of PPs maintains healthier brain features and cognitive function, and that this beneficial effect is mediated by gut microbiota metabolites of PPs and BAs.
In this multi-PI application by leaders in the field of brain-gut microbiome interactions, the investigators will conduct a year-long, multi-center, randomized double-blind placebo-controlled study in 300 older adults in the United States (validation sample of 100 from Northern Ireland) who are at enhanced risk of developing AD. Ultimately, the investigators will establish the protective effects of regular dietary PP intake on cognitive function and on brain-gut microbiome interactions, ideally allowing the development of effective dietary regimes to prevent of delay the onset of AD in at-risk elderly, thereby reducing cognitive decline and healthcare costs.
Participants will be asked to provide information about their diet, mood, and behaviors via food diaries, physical body measures (e.g. height, weight, etc.), and online questionnaires collected before each in-clinic appointment, as well as monthly online questionnaires. MR imaging will be collected on participants to assess neurocognitive changes as a result of the supplement. Participants will be asked to provide both stool and blood samples. Participants will be randomly assigned to either the Juice Plus+ intervention group or the placebo treatment group and then asked to take their respective supplement 4 pills twice a day. All participants will be asked to come in for 4 in-clinic appointments, including 3 brain MRI scans and 3 cognitive testing appointments, collect 3 stool samples with corresponding diet diaries, and provide 3 blood samples over the course of 12 months. Participants will also meet with a nutritionist 3 times over the 12 months to discuss diet to ensure study eligibility and any questions about the supplement.
- Conditions
- Cognitive Decline, Cognitive Dysfunction
- Being tested
- Polyphenol Supplement, Placebo Supplement
- Keywords
- Polyphenols, Mediterranean Diet, Gut Microbiome, Alzheimers Disease
- Medical subject headings
- Cognitive Dysfunction, Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Polyphenol SupplementDietary supplement
Also called Juice Plus Essentials, Berry Blend Capsules
Dietary supplement taken twice daily for 12 months.
Placebo SupplementDietary supplement
Dietary supplement taken twice daily for 12 months.
| Study group | Role | What they receive |
|---|---|---|
| Polyphenol Supplement | Experimental | Juice Plus Essentials, Berry Blend Capsules Receives: Dietary Supplement: Polyphenol Supplement |
| Placebo Supplement | Placebo comparator | Not described Receives: Dietary Supplement: Placebo Supplement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Differences in Polyphenol-derived metabolite concentrations pre, mid, & post intervention - stool
Measurement of metabolomics via stool specimen.
Measured: Collected three times by the participant at home, once at baseline (week 0), once at mid-study (month 6), and once at the final 12month appointment (month 12).
Differences in Polyphenol-derived metabolite concentrations pre, mid, & post intervention - blood
Measurement of metabolomics via blood specimen.
Measured: Collected three times, once at baseline appointment (week 0), once at mid-study appointment (month 6), and once at the final 12month appointment (month 12).
Differences in microbiome levels pre, mid, & post intervention - Stool
16S RNA sequencing to measure microbiome levels via stool specimen.
Measured: Collected three times by the participant at home, once at baseline (week 0), once at mid-study (month 6), and once at the final 12month appointment (month 12).
Differences in microbiome levels pre & post intervention - Blood
16S RNA sequencing to measure microbiome levels via blood specimen.
Measured: Collected three times, once at baseline appointment (week 0), once at mid-study appointment (month 6), and once at the final 12month appointment (month 12).
Differences in microbiome levels pre, mid, & post intervention - Stool
Shotgun metagenomics, sequencing to measure microbiome levels via stool specimen.
Measured: Collected three times by the participant at home, once at baseline (week 0), once at mid-study (month 6), and once at the final 12month appointment (month 12).
Differences in microbiome levels pre, mid, & post intervention - Blood
Shotgun metagenomics, sequencing to measure microbiome levels via blood specimen.
Measured: Collected three times, once at baseline appointment (week 0), once at mid-study appointment (month 6), and once at the final 12month appointment (month 12).
Differences in Cognitive Measures pre, mid, & post intervention - Executive Function
Administration of a standardized Stroop Neuro-psychological test; participants ability to correctly identify colors when words are printed in conflicting ink colors.
Measured: Collected three times, once at baseline appointment (week 0), once at mid-study appointment (month 6), and once at the final 12month appointment (month 12).
Differences in Cognitive Measures pre, mid, & post intervention - Executive Function
Administration of a standardized Trails A \& B; participants ability to connect dots, in order, as quickly as possible.
Measured: Collected three times, once at baseline appointment (week 0), once at mid-study appointment (month 6), and once at the final 12month appointment (month 12).
Differences in Cognitive Measures pre, mid, & post intervention
The Repeatable Battery for the Assessment of Neuropsychological Status (RBANS)
Measured: Collected three times, once at baseline appointment (week 0), once at mid-study appointment (month 6), and once at the final 12month appointment (month 12).
Differences in Cognitive Measures pre, mid, and post intervention - Executive Functioning
Administration of a standardized arithmetic task; participants ability to complete quick mental math.
Measured: Collected three times, once at baseline appointment (week 0), once at mid-study appointment (month 6), and once at the final 12month appointment (month 12).
Secondary outcomes (9)
Differences in tryptophan-associated metabolite profiles pre, mid, and post intervention - Stool
Measurement of tryptophan-associate metabolite profiles via stool specimen.
Measured: Collected three times, once at baseline appointment (week 0), once at mid-study appointment (month 6), and once at the final 12month appointment (month 12).
Differences in Bile Acid's (BA's) pre, mid, & post intervention - Stool
Measurement of BA's via stool specimen.
Measured: Collected three times, once at baseline appointment (week 0), once at mid-study appointment (month 6), and once at the final 12month appointment (month 12).
Differences in Inflammatory markers pre, mid, & post intervention - Blood
Measurement of inflammatory markers via blood specimen.
Measured: Collected three times, once at baseline appointment (week 0), once at mid-study appointment (month 6), and once at the final 12month appointment (month 12).
Differences in Alzheimer's Disease (AD) markers pre, mid, & post intervention - Blood
Measurement of AD markers via blood specimen.
Measured: Collected three times, once at baseline appointment (week 0), once at mid-study appointment (month 6), and once at the final 12month appointment (month 12).
Anthropometrics - BMI
Measurement of height(in) and weight(lbs), used to calculate body mass index (BMI)
Measured: Measured three times, once at each in-clinic appointment (week 0, month 6, month 12)
Questionnaire Data
Use of validated surveys to assess ingestive behaviors, social isolation, stress, health, physical activity, etc., self-reported by the participant at home.
Measured: Collected 3 times (1) before beginning the dietary supplement, (2) mid-study month 6, (3) end of study month 12.
Monthly Questionnaire Data
Use of validated surveys to assess anxiety, depression, stress, and diet, self-reported by the participant at home,
Measured: Collected once a month for the duration of the study (12months).
Anthropometrics - waist and hip circumference
Measurement of waist and hip circumference (cm)
Measured: Measured three times, once at each in-clinic appointment (week 0, month 6, & month 12)
Systolic and Diastolic Blood Pressure
Measurement of the pressure of circulating blood at rest
Measured: Measured three times, once at each in-clinic appointment (week 0, month 6, month 12).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2024
- Study start9 Jan 2025
- Primary completion30 Jun 2029 (estimated)
- Study completion31 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cognitive DeclineStudies of the same condition, open and under way.
- More trials run by University of California, Los AngelesThe 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
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, Los Angeles
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Arpana Church, University of California, Los Angeles
- Investigators
- Arpana Church, PhD, Principal investigator, The Regents of the University of California, Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06507254
- Sponsor's protocol ID
- IRB 24-000113
- Other IDs
- 1R01AG081768
- Acronym
- MAEVE
- Status last verified
- Jun 2026
- First submitted
- 15 May 2024
- Last updated
- 11 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MAEVE: Microbiota Mediated Flavonoid Metabolites for Cognitive Health
- ClinicalTrials.gov ID
- NCT06507254
- Acronym / sponsor ID
- MAEVE / IRB 24-000113
- Conditions
- Cognitive Decline, Cognitive Dysfunction
- Keywords
- Polyphenols, Mediterranean Diet, Gut Microbiome, Alzheimers Disease
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- University of California, Los AngelesUniversity, hospital or other
- Study start
- 9 Jan 2025 (actual)
- Primary completion
- 30 Jun 2029 (estimated)
- Study completion
- 31 Dec 2029 (estimated)
- First posted
- 18 Jul 2024 (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.
Globally, populations are aging thereby increasing healthcare burden, overall cognitive impairment, and dementia including Alzheimers diseases (AD). The lack of effective treatments makes it essential to develop new strategies for healthy cognitive aging, including interventions to slow or prevent cognitive decline. A traditional Mediterranean diet, rich in polyphenols (PPs), may prevent or delay the onset of cognitive dysfunction in older adults, preserving healthy brain structure and function, and lowering the risk of AD. These effects, mediated in part by gut microbiome-derived PP metabolites, highlight the role alterations in the brain-gut microbiome system play in neurodegeneration. Moreover, high levels of circulating phenyl-y-valerolactones, neuroprotective compounds, exclusively produced by gut microbiota from flavan-3-ol-rich foods (e.g., cocoa, tea, berries) are associated with delaying the onset of cognitive dysfunction in older adults. Intake of such PPs can also change gut microbial composition and function, altering the physiology of the hosts secondary bile acid (BA) pool, affecting regulatory and signaling functions in the brain as well as cognitive decline and AD. The investigators hypothesize that, in older adults with enhanced AD risk, dietary intake of PPs maintains healthier brain features and cognitive function, and that this beneficial effect is mediated by gut microbiota metabolites of PPs and BAs.
In this multi-PI application by leaders in the field of brain-gut microbiome interactions, the investigators will conduct a year-long, multi-center, randomized double-blind placebo-controlled study in 300 older adults in the United States (validation sample of 100 from Northern Ireland) who are at enhanced risk of developing AD. Ultimately, the investigators will establish the protective effects of regular dietary PP intake on cognitive function and on brain-gut microbiome interactions, ideally allowing the development of effective dietary regimes to prevent of delay the onset of AD in at-risk elderly, thereby reducing cognitive decline and healthcare costs.
Participants will be asked to provide information about their diet, mood, and behaviors via food diaries, physical body measures (e.g. height, weight, etc.), and online questionnaires collected before each in-clinic appointment, as well as monthly online questionnaires. MR imaging will be collected on participants to assess neurocognitive changes as a result of the supplement. Participants will be asked to provide both stool and blood samples. Participants will be randomly assigned to either the Juice Plus+ intervention group or the placebo treatment group and then asked to take their respective supplement 4 pills twice a day. All participants will be asked to come in for 4 in-clinic appointments, including 3 brain MRI scans and 3 cognitive testing appointments, collect 3 stool samples with corresponding diet diaries, and provide 3 blood samples over the course of 12 months. Participants will also meet with a nutritionist 3 times over the 12 months to discuss diet to ensure study eligibility and any questions about the supplement.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Polyphenol Supplement | Experimental | Dietary Supplement: Polyphenol SupplementJuice Plus Essentials, Berry Blend Capsules |
| Placebo Supplement | Placebo comparator | Dietary Supplement: Placebo Supplement |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 50+ Years of age
- Male or Female
- At enhanced risk of Alzheimer's Disease (defined as family history of AD, 1st degree family member)
- Habitually consume suboptimal diets such as typical Western Diet (i.e., high in animal products, refined carbohydrates and processed food)
- Able to communicate well in English
Key exclusion criteria (16 listed)
- Vegan or Vegetarian
- Presence of cognitive impairment at the time of recruitment into the study as measured by the Mini Mental Status Exam (MMSE, score 25-30) and Clinical Dementia Rating (CDR, score=0).
- Pre-existing psychosis or psychiatric conditions
- Currently receiving treatment for dementia
- History of alcohol and/or substance abuse/dependence as determined by a positive endorsement on the MINI+/ If the MINI+ is positive for alcohol or drug dependence, or abuse, the participants will be excluded.
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 |
|---|---|---|
| Polyphenol SupplementAlso: Juice Plus Essentials, Berry Blend CapsulesDietary supplement taken twice daily for 12 months. | Dietary supplement | Polyphenol Supplement |
| Placebo SupplementDietary supplement taken twice daily for 12 months. | Dietary supplement | Placebo Supplement |
Primary outcome
Differences in Polyphenol-derived metabolite concentrations pre, mid, & post intervention - stool
Time frame: Collected three times by the participant at home, once at baseline (week 0), once at mid-study (month 6), and once at the final 12month appointment (month 12).
Measurement of metabolomics via stool specimen.
Differences in Polyphenol-derived metabolite concentrations pre, mid, & post intervention - blood
Time frame: Collected three times, once at baseline appointment (week 0), once at mid-study appointment (month 6), and once at the final 12month appointment (month 12).
Measurement of metabolomics via blood specimen.
Differences in microbiome levels pre, mid, & post intervention - Stool
Time frame: Collected three times by the participant at home, once at baseline (week 0), once at mid-study (month 6), and once at the final 12month appointment (month 12).
16S RNA sequencing to measure microbiome levels via stool specimen.
Differences in microbiome levels pre & post intervention - Blood
Time frame: Collected three times, once at baseline appointment (week 0), once at mid-study appointment (month 6), and once at the final 12month appointment (month 12).
16S RNA sequencing to measure microbiome levels via blood specimen.
Differences in microbiome levels pre, mid, & post intervention - Stool
Time frame: Collected three times by the participant at home, once at baseline (week 0), once at mid-study (month 6), and once at the final 12month appointment (month 12).
Shotgun metagenomics, sequencing to measure microbiome levels via stool specimen.
Differences in microbiome levels pre, mid, & post intervention - Blood
Time frame: Collected three times, once at baseline appointment (week 0), once at mid-study appointment (month 6), and once at the final 12month appointment (month 12).
Shotgun metagenomics, sequencing to measure microbiome levels via blood specimen.
Differences in Cognitive Measures pre, mid, & post intervention - Executive Function
Time frame: Collected three times, once at baseline appointment (week 0), once at mid-study appointment (month 6), and once at the final 12month appointment (month 12).
Administration of a standardized Stroop Neuro-psychological test; participants ability to correctly identify colors when words are printed in conflicting ink colors.
Differences in Cognitive Measures pre, mid, & post intervention - Executive Function
Time frame: Collected three times, once at baseline appointment (week 0), once at mid-study appointment (month 6), and once at the final 12month appointment (month 12).
Administration of a standardized Trails A \& B; participants ability to connect dots, in order, as quickly as possible.
Differences in Cognitive Measures pre, mid, & post intervention
Time frame: Collected three times, once at baseline appointment (week 0), once at mid-study appointment (month 6), and once at the final 12month appointment (month 12).
The Repeatable Battery for the Assessment of Neuropsychological Status (RBANS)
Differences in Cognitive Measures pre, mid, and post intervention - Executive Functioning
Time frame: Collected three times, once at baseline appointment (week 0), once at mid-study appointment (month 6), and once at the final 12month appointment (month 12).
Administration of a standardized arithmetic task; participants ability to complete quick mental math.
9 secondary outcomes
Differences in tryptophan-associated metabolite profiles pre, mid, and post intervention - Stool
Time frame: Collected three times, once at baseline appointment (week 0), once at mid-study appointment (month 6), and once at the final 12month appointment (month 12).
Differences in Bile Acid's (BA's) pre, mid, & post intervention - Stool
Time frame: Collected three times, once at baseline appointment (week 0), once at mid-study appointment (month 6), and once at the final 12month appointment (month 12).
Differences in Inflammatory markers pre, mid, & post intervention - Blood
Time frame: Collected three times, once at baseline appointment (week 0), once at mid-study appointment (month 6), and once at the final 12month appointment (month 12).
Differences in Alzheimer's Disease (AD) markers pre, mid, & post intervention - Blood
Time frame: Collected three times, once at baseline appointment (week 0), once at mid-study appointment (month 6), and once at the final 12month appointment (month 12).
Anthropometrics - BMI
Time frame: Measured three times, once at each in-clinic appointment (week 0, month 6, month 12)
Questionnaire Data
Time frame: Collected 3 times (1) before beginning the dietary supplement, (2) mid-study month 6, (3) end of study month 12.
Monthly Questionnaire Data
Time frame: Collected once a month for the duration of the study (12months).
Anthropometrics - waist and hip circumference
Time frame: Measured three times, once at each in-clinic appointment (week 0, month 6, & month 12)
Systolic and Diastolic Blood Pressure
Time frame: Measured three times, once at each in-clinic appointment (week 0, month 6, month 12).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2026.
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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.
Arpana Church, PhD principal investigator
The Regents of the University of California, Los Angeles
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Polyphenol Supplement in people with Cognitive Decline and Cognitive Dysfunction, run by University of California, Los Angeles at 1 site 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 5 inclusion and 16 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: looking for participants now, as of the sponsor's last update on 11 Jun 2026. 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 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Marika Dy, MPH (2670089, ChurchLab@mednet.ucla.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Differences in Polyphenol-derived metabolite concentrations pre, mid, & post intervention - stool (time frame: Collected three times by the participant at home, once at baseline (week 0), once at mid-study (month 6), and once at the final 12month appointment (month 12).). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 11 Jun 2026.