Twelve-Month Study of Pomegranate Extract in Normal Aging

Inclusion Criteria:

• Agreement to participate in the 12-month double-blind, placebo-controlled clinical trial of pomegranate extract.
• Nondemented subjects either those with normal cognition or with amnestic Mild Cognitive Impairment will be included.
• Age 50 to 75 years.
• No significant cerebrovascular disease: modified Ischemic Score of < 4 (Rosen et al, 1980).
• Adequate visual and auditory acuity to allow neuropsychological testing.
• Screening laboratory tests and EKG without significant abnormalities that might interfere with the study.

Exclusion Criteria:

• Diagnosis of probable Alzheimer's disease (AD) or any other dementia (e.g., vascular, Lewy body, frontotemporal) (McKhann et al, 1984). Evidence of other neurological or physical illness that can produce cognitive deterioration. Volunteers with a history of stroke, TIA, carotid bruits, or lacunes on MRI scans will be excluded. Determination of dementia will be based on the clinical evaluation including assessment of functional abilities, and cognitive screening.
• Contraindication to the MRI including claustrophobia, metal in body, surgery within 60 days, certain implants or previous abnormal MRI results.
• Evidence of Parkinson's disease as determined by the motor examination (items 18-31) of the Unified Parkinson's Disease Rating Scale (Fahn et al, 1987).
• History of myocardial infarction within the previous year, or unstable cardiac disease.
• Uncontrolled hypertension (systolic BP > 170 or diastolic BP > 100).
• History of significant liver disease, clinically-significant pulmonary disease, diabetes, or cancer.
• Current diagnosis of any major psychiatric disorder according to the DSM-IV TR criteria (APA, 2000).
• Current diagnosis or history of alcoholism or substance addiction.
• Regular use of any medication that may affect cognitive functioning including: centrally active beta-blockers, narcotics, Clonidine, anti-Parkinsonian medications, antipsychotics, benzodiazepines, systemic corticosteroids, medications with significant cholinergic or anticholinergic effects, anti-convulsants, or Warfarin. Occasional chloral hydrate use will be allowed, but discouraged, for insomnia.
• Use of more than one multivitamin per day. Vitamins other than the standard multivitamin supplement will not be allowed.
• Use of cognitive enhancing supplements (e.g. Ginkgo biloba).
• Use of any medications metabolized by 2C9 including: fluconazole, amiodarone, fenofibrate, fluvastatin, fluvoxamine, isoniazid, lovastatin, phenylbutazone, probenecid, sertraline, sulfamethoxazole, sulfaphenazole
• teniposide, voriconazole, and zafirlukast.
• Use of more than one daily baby aspirin (81mg) and/or use of any supplement containing pomegranate.
• Use of any investigational drugs within the previous month or longer, depending on drug half-life.
• Pregnancy.