Cognitive Decline study: Polyphenol Supplement
Official title Polyphenols and Cognitive Decline
ClinicalTrials.gov ID: NCT06507254
What this study is testing
- What it's testing
- The study will see whether daily intake of polyphenols can keep brain structure and function healthier and delay cognitive problems in people who may develop Alzheimer’s disease.
- Who it's for
- Older adults in the U.S. and Northern Ireland who have an increased risk of Alzheimer’s disease.
- What's involved
- Participants will take either the polyphenol supplement or a placebo, 4 pills twice a day, for 12 months. They will attend four clinic visits for brain MRIs, cognitive tests, stool and blood samples, and meet a nutritionist three times. They will also keep food diaries and answer online questionnaires.
- Time commitment
- The study lasts 12 months, with four clinic visits, three MRIs, three cognitive tests, three stool and blood samples, and three nutritionist meetings.
You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 50 and older. Healthy volunteers may be eligible.
You may be able to join if
- 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
You likely can't join if
- 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...
- 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...
- Heavy use of tobacco (greater than 1/2 pack per day)
See the full eligibility criteria
- 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
- 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)
- 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.
- Chronic Pain
The study team makes the final eligibility decision.
Where it is enrolling
- Los Angeles, California, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 50 years and older. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Los Angeles, California, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.