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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02033941
Recruitment Status : Unknown
Verified December 2020 by Hillel Grossman, Icahn School of Medicine at Mount Sinai.
Recruitment status was:  Active, not recruiting
First Posted : January 13, 2014
Last Update Posted : December 23, 2020
Sponsor:
Collaborator:
National Center for Complementary and Integrative Health (NCCIH)
Information provided by (Responsible Party):
Hillel Grossman, Icahn School of Medicine at Mount Sinai

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Alzheimer's Disease Drug: Meganatural-Az Grapeseed Extract Drug: Placebo Phase 2

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Phase II Grape Seed Extract as Anti-Oligomerization Agent in Alzheimer's Disease
Study Start Date : November 2014
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : December 2021

Resource links provided by the National Library of Medicine


Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. pharmacokinetic analysis [ Time Frame: up to 22 months ]
    the pharmacokinetics and effects of Meganatural-Az® on tau and abnormally phosphorylated tau CSF concentrations

  2. primary safety evaluations [ Time Frame: up to 22 months ]
    adverse effects reporting


Secondary Outcome Measures :
  1. AD Biomarkers [ Time Frame: up to 22 months ]
    β-amyloid (Aβ) in plasma and in cerebral spinal fluid (CSF) specimens

  2. cognitive and functional assessments [ Time Frame: up to 22 months ]
    cognitive and functional assessments including the ADAS-cog, ADCS CGIC, MMSE, and ADL.


Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02033941


Locations
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United States, New York
Mount Sinai Alzheimer's Disease Research Center
New York, New York, United States, 10029
Sponsors and Collaborators
Hillel Grossman
National Center for Complementary and Integrative Health (NCCIH)
Investigators
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Principal Investigator: Hillel Grossman, MD Mount Sinai School of Medcine
Principal Investigator: Samuel Gandy, MD/PhD Icahn School of Medicine at Mount Sinai
More Information
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Additional Information:

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Responsible Party: Hillel Grossman, Associate Professor, Icahn School of Medicine at Mount Sinai
ClinicalTrials.gov Identifier: NCT02033941    
Other Study ID Numbers: GCO 09-0307
5R21AT005510 ( U.S. NIH Grant/Contract )
First Posted: January 13, 2014    Key Record Dates
Last Update Posted: December 23, 2020
Last Verified: December 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Hillel Grossman, Icahn School of Medicine at Mount Sinai:
Alzheimer's Disease
Grapeseed Extract
Clinical Trial
Meganatural-AZ
 anti-oligomerization
Phase 2
Dietary Supplement
Nutraceutical
Additional relevant MeSH terms:
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Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
 Mental Disorders
Phenol
Anti-Infective Agents, Local
Anti-Infective Agents
Disinfectants
Sclerosing Solutions
Pharmaceutical Solutions