Resveratrol for Alzheimer's Disease
Condition: Alzheimer's Disease
MeSH terms: Alzheimer Disease
Intervention: Resveratrol; Placebo
Intervention description: The dosage will begin at 500 mg taken once daily and increase at 13 week intervals to 1 gram taken by mouth twice daily, supplied as 500 mg capsules (two capsules twice daily).; The matching placebo will begin at a capsule taken once daily and increase at 13 week intervals to two capsules twice daily.
Intervention MeSH terms: Resveratrol
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 119.0
Sex: All
Minimum age: 50 Years
Healthy volunteers: No
Keywords: Alzheimer's disease; Dementia; Brain diseases; Resveratrol; Memory problems; Mental disorders; Cognitive disorders

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.