Alzheimer's Disease Clinical Trial
Official title:
Phase II Grape Seed Extract as Anti-Oligomerization Agent in Alzheimer's Disease
Verified date | June 2023 |
Source | Icahn School of Medicine at Mount Sinai |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Alzheimer Disease (AD) is a progressive brain disease generally known as senile dementia. Our proposed study will establish safety and pharmacokinetics of Meganatural-AZ GSPE in AD subjects. As secondary measures, we will also provide the essential human data to guide the design of future studies to test the efficacy of GSPE in mitigating cognitive deterioration in AD patients.
Status | Suspended |
Enrollment | 20 |
Est. completion date | March 2024 |
Est. primary completion date | March 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | Mount Sinai Alzheimer's Disease Research Center | New York | New York |
Lead Sponsor | Collaborator |
---|---|
Hillel Grossman | National Center for Complementary and Integrative Health (NCCIH) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | pharmacokinetic analysis | the pharmacokinetics and effects of Meganatural-Az® on tau and abnormally phosphorylated tau CSF concentrations | up to 22 months | |
Primary | primary safety evaluations | adverse effects reporting | up to 22 months | |
Secondary | AD Biomarkers | ß-amyloid (Aß) in plasma and in cerebral spinal fluid (CSF) specimens | up to 22 months | |
Secondary | cognitive and functional assessments | cognitive and functional assessments including the ADAS-cog, ADCS CGIC, MMSE, and ADL. | up to 22 months |
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