Trial record 2 of 3 for:    Dementia | Open Studies | Exclude Unknown | NCCAM

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

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified January 2014 by Mount Sinai School of Medicine
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Hillel Grossman, Mount Sinai School of Medicine
ClinicalTrials.gov Identifier:
NCT02033941
First received: January 9, 2014
Last updated: NA
Last verified: January 2014
History: No changes posted
  Purpose

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 Intervention Phase
Alzheimer's Disease
Drug: Meganatural-Az Grapeseed Extract
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Phase II Grape Seed Extract as Anti-Oligomerization Agent in Alzheimer's Disease

Resource links provided by NLM:


Further study details as provided by Mount Sinai School of Medicine:

Primary Outcome Measures:
  • pharmacokinetic analysis [ Time Frame: up to 22 months ] [ Designated as safety issue: Yes ]
    the pharmacokinetics and effects of Meganatural-Az® on tau and abnormally phosphorylated tau CSF concentrations

  • primary safety evaluations [ Time Frame: up to 22 months ] [ Designated as safety issue: Yes ]
    adverse effects reporting


Secondary Outcome Measures:
  • AD Biomarkers [ Time Frame: up to 22 months ] [ Designated as safety issue: No ]
    β-amyloid (Aβ) in plasma and in cerebral spinal fluid (CSF) specimens

  • cognitive and functional assessments [ Time Frame: up to 22 months ] [ Designated as safety issue: No ]
    cognitive and functional assessments including the ADAS-cog, ADCS CGIC, MMSE, and ADL.


Estimated Enrollment: 20
Study Start Date: January 2014
Estimated Study Completion Date: November 2015
Estimated Primary Completion Date: November 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02033941

Contacts
Contact: Emily Exter, BA 212-241-8329 emily.exter@mssm.edu
Contact: Hillel Grossman, MD 212-241-8329 hillel.grossman@mssm.edu

Locations
United States, New York
Mount Sinai Alzheimer's Disease Research Center Not yet recruiting
New York, New York, United States, 10029
Contact: Emily Exter, BA    212-241-8329    emily.exter@mssm.edu   
Contact: Amanda Burden, BA    212-241-8329    amanda.burden@mssm.edu   
Principal Investigator: Hillel T Grossman, MD         
Sponsors and Collaborators
Hillel Grossman
Investigators
Principal Investigator: Hillel Grossman, MD Mount Sinai School of Medcine
Principal Investigator: Samuel Gandy, MD/PhD Mount Sinai School of Medicine
  More Information

Additional Information:
No publications provided

Responsible Party: Hillel Grossman, Associate Professor, Mount Sinai School of Medicine
ClinicalTrials.gov Identifier: NCT02033941     History of Changes
Other Study ID Numbers: GCO 09-0307, 5R21AT005510, HSM 10-00115
Study First Received: January 9, 2014
Last Updated: January 9, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Mount Sinai School of Medicine:
Alzheimer's Disease
Grapeseed Extract
Clinical Trial
Meganatural-AZ
anti-oligomerization
Phase 2
Dietary Supplement
Nutraceutical

Additional relevant MeSH terms:
Delirium, Dementia, Amnestic, Cognitive Disorders
Dementia
Alzheimer Disease
Brain Diseases
Central Nervous System Diseases
Mental Disorders
Nervous System Diseases
Neurodegenerative Diseases
Tauopathies
Grape Seed Extract
Antineoplastic Agents
Antineoplastic Agents, Phytogenic
Antioxidants
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Protective Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014