Phase 2
N=119
Resveratrol for Alzheimer's Disease
Alzheimer's Disease
Bottom Line
View on ClinicalTrials.gov: NCT01504854 ↗Enrolled (actual)
119
Serious AEs
19.3%
Results posted
Jun 2016
Primary outcome: Primary: Number of Adverse Events — 355; 302 number of AEs
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Resveratrol (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 50+ yrs
- Sex
- All
- Sponsor
- Alzheimer's Disease Cooperative Study (ADCS)
- Primary completion
- Mar 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Adverse Events |
355; 302 | — |
| PRIMARY Change From Baseline in Volumetric Magnetic Resonance Imaging (MRI) |
27; 10 | — |
| SECONDARY Change in Alzheimer's Disease Cooperative Study-Activities of Daily Living (ADCS-ADL) |
6.3; 9.2 | — |
| SECONDARY Comparison of the Response to Treatment of Resveratrol Based on ApoE Genotype |
6574; 6560; 5859; 6339 | — |
Summary
Resveratrol is derived from plants and is found in highest levels in red wine and the skin of red grapes. A recent study reported that monthly and weekly consumption of red wine is associated with a lower risk of dementia. There is compelling evidence that caloric restriction can improve overall health by activating a class of enzymes known as Sirtuins. Resveratrol is a substance found in some plants that directly activates sirtuins, mimicking the effects of caloric restriction and may affect regulatory pathways of diseases of aging, including Alzheimer's disease (AD).
In this study, people with AD will be given either Resveratrol or placebo for 12 months to determine whether daily resveratrol therapy is beneficial in delaying or altering the deterioration of memory and daily functioning. Subjects age 50 and above with a diagnosis of probable AD may qualify for participation in this study. A small group of 15 participants will be asked to take part in a more detailed 24-hour Pharmacokinetic (PK) sub-study that will measure resveratrol levels over a 24 hour period.
Eligibility Criteria
Inclusion Criteria
- Diagnosis of probable AD (NINDS-ADRDA criteria).
- Age must be 50 years or older.
- Able to ingest oral medications.
- Caregiver/Study Partner who has direct contact with the participant more than 2 days per week to accompany participant to all visits.
- MMSE score between 14 and 26 (inclusive).
- Modified Hachinski score of less than or equal to 4.
- Able to abstain from ingesting large quantities of resveratrol-containing foods (including red wine). 1-2 glasses of red wine or red grape juice daily acceptable; 1 serving of red grapes daily acceptable.
- Able to abstain from ingesting herbal/natural preparations or dietary supplements containing resveratrol.
Exclusion Criteria
- Non-AD dementia.
- Probable AD with Down syndrome.
- History of clinically significant stroke.
- Current evidence or history in past two years of epilepsy, focal brain lesion, head injury with loss of consciousness or DSM-IV criteria for any major psychiatric disorder including psychosis, major depression, bipolar disorder, alcohol or substance abuse.
- Sensory impairment that would preclude the participant from participating in or cooperating with the protocol.
- Use of investigational agent within two months of Screening.
- Evidence of any significant clinical disorder or laboratory finding that renders the participant unsuitable for receiving an investigational drug including clinically significant or unstable hematologic, hepatic, cardiovascular, pulmonary, gastrointestinal, endocrine, metabolic, renal or other systemic disease or laboratory abnormality.
- Active neoplastic disease, history of cancer five years prior to screening, including breast cancer (history or skin melanoma or stable prostate cancer are not excluded).
- History of seizure within past five years.
- Pregnancy or possible pregnancy.
- Use of resveratrol containing supplements.
Data sourced from ClinicalTrials.gov (NCT01504854). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.