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

Alzheimer's Disease Clinical Trial

Official title:

Phase II Grape Seed Extract as Anti-Oligomerization Agent in Alzheimer's Disease

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT02033941
• Other study ID #: GCO 09-0307
• Secondary ID: 5R21AT005510
• Status: Suspended
• Phase: Phase 2
• 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
• 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

Related Conditions & MeSH terms

• Alzheimer Disease
• Alzheimer's Disease

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

External Links

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