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

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

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.

Study Overview

• Status: Terminated
• Conditions: Alzheimer's Disease
• Intervention / Treatment: Drug: Meganatural-Az Grapeseed Extract; Drug: Placebo

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 10
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10029
      • Mount Sinai Alzheimer's Disease Research Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Meganatural-Az Grapeseed Extract; Meganatural-Az® doses: 30mg / day for 2 weeks; 4 weeks of 600 mg/day, 4 weeks 1000mg / day	Drug: Meganatural-Az Grapeseed Extract; Meganatural-Az® doses: 30mg / day for 2 weeks; 4 weeks of 600 mg/day, 4 weeks 1000mg / day; Other Names: Grapeseed Polyphenolic Extract; Grapeseed Phenol Extract; GSPE
Placebo Comparator: Placebo; Subjects receive capsules identical in appearance to the active agent with the same incremental schedule	Drug: Placebo; Subjects receive capsules identical in appearance to the active agent with the same incremental schedule

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
pharmacokinetic analysis	the pharmacokinetics and effects of Meganatural-Az® on tau and abnormally phosphorylated tau CSF concentrations	up to 22 months
primary safety evaluations	adverse effects reporting	up to 22 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
AD Biomarkers	β-amyloid (Aβ) in plasma and in cerebral spinal fluid (CSF) specimens	up to 22 months
cognitive and functional assessments	cognitive and functional assessments including the ADAS-cog, ADCS CGIC, MMSE, and ADL.	up to 22 months

Collaborators and Investigators

• Sponsor: Hillel Grossman
• Collaborators: National Center for Complementary and Integrative Health (NCCIH)
• Investigators: Principal Investigator: Hillel Grossman, MD, Mount Sinai School of Medcine; Principal Investigator: Samuel Gandy, MD/PhD, Icahn School of Medicine at Mount Sinai

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start (Actual): July 3, 2018
• Primary Completion (Actual): October 4, 2019
• Study Completion (Actual): October 4, 2019

Study Registration Dates

• First Submitted: January 9, 2014
• First Submitted That Met QC Criteria: January 9, 2014
• First Posted (Estimated): January 13, 2014

Study Record Updates

• Last Update Posted (Actual): October 15, 2024
• Last Update Submitted That Met QC Criteria: October 11, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Keywords: Alzheimer's Disease; Clinical Trial; Nutraceutical; Phase 2; Dietary Supplement; Grapeseed Extract; Meganatural-AZ; anti-oligomerization
• Additional Relevant MeSH Terms: Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Neurodegenerative Diseases; Dementia; Tauopathies; Alzheimer Disease; Anti-Infective Agents, Local; Anti-Infective Agents; Pharmaceutical Solutions; Disinfectants; Sclerosing Solutions; Phenol
• Other Study ID Numbers: GCO 09-0307; 5R21AT005510 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No