Phase 2 Study to Examine Grape Seed Extract as an Anti-Oligomerization Agent in Alzheimer's Disease (AD)

This study aims to establish the safety and pharmacokinetics of Meganatural-Az® GSPE in
subjects with Alzheimer's disease. As a secondary goal, clinical and biomarker indices of
therapeutic efficacy will also be evaluated. The proposed study will provide the essential
human data necessary to guide the design of future studies testing the efficacy of GSPE in
mitigating cognitive deterioration in AD patients.

Inclusion Criteria:

- NINCDS/ADRDA criteria for probable AD

- MMSE between 12-26

- Treatment with a cholinesterase inhibitor or an NMDA (N-methyl-D-asparate) antagonist
with stable dose for at least 12 weeks

- Home monitoring available for supervision of medications

- Caregiver available to accompany patient to all visits and willing to participate in
study as informant

- Fluent in English or Spanish

- Medical stability for this study as confirmed by review of records, internist's
physical exam, neurological exam, and laboratory tests

- Stable doses of non-excluded medication

- No evidence of hepatic insufficiency

- Able to swallow oral medications

- Ability to participate in the informed consent process

Exclusion Criteria:

- History of hypotension or unstable hypertension

- Active hepatic or renal disease

- Use of another investigational drug within the past two months

- History of clinically significant stroke

- History of seizure or head trauma with disturbance of consciousness within the past
two years

- Major mental illness including psychotic disorders, bipolar disorder, or major
depressive episode that is not in remission for less than 12 months

- Women of child-bearing age unless using effective birth control or at least one year
post-menopausal or surgically menopausal

- Any ferrous or metallic materials which are contraindicated for MRI

Medication Exclusions

- Current use of drugs with significant anticholinergic or antihistaminic properties