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Clinical Trial Details — Status: Suspended

Administrative data

NCT number NCT02033941
Other study ID # GCO 09-0307
Secondary ID 5R21AT005510
Status Suspended
Phase Phase 2
First received
Last updated
Start date July 3, 2018
Est. completion date March 2024

Study information

Verified date June 2023
Source Icahn School of Medicine at Mount Sinai
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Description:

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.


Recruitment information / eligibility

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

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Meganatural-Az Grapeseed Extract
Meganatural-Az® doses: 30mg / day for 2 weeks; 4 weeks of 600 mg/day, 4 weeks 1000mg / day
Placebo
Subjects receive capsules identical in appearance to the active agent with the same incremental schedule

Locations

Country Name City State
United States Mount Sinai Alzheimer's Disease Research Center New York New York

Sponsors (2)

Lead Sponsor Collaborator
Hillel Grossman National Center for Complementary and Integrative Health (NCCIH)

Country where clinical trial is conducted

United States, 

Outcome

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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