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

Primary Purpose

Alzheimer's Disease

Status

Suspended

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

Meganatural-Az Grapeseed Extract

Placebo

About this trial

This is an interventional treatment trial for Alzheimer's Disease focused on measuring Alzheimer's Disease, Grapeseed Extract, Clinical Trial, Meganatural-AZ, anti-oligomerization, Phase 2, Dietary Supplement, Nutraceutical

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Mount Sinai Alzheimer's Disease Research Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Meganatural-Az Grapeseed Extract

Placebo

Arm Description

Meganatural-Az® doses: 30mg / day for 2 weeks; 4 weeks of 600 mg/day, 4 weeks 1000mg / day

Subjects receive capsules identical in appearance to the active agent with the same incremental schedule

Outcomes

Primary Outcome Measures

pharmacokinetic analysis

the pharmacokinetics and effects of Meganatural-Az® on tau and abnormally phosphorylated tau CSF concentrations

primary safety evaluations

adverse effects reporting

Secondary Outcome Measures

AD Biomarkers

β-amyloid (Aβ) in plasma and in cerebral spinal fluid (CSF) specimens

cognitive and functional assessments

cognitive and functional assessments including the ADAS-cog, ADCS CGIC, MMSE, and ADL.

Full Information

NCT ID

NCT02033941

First Posted

January 9, 2014

Last Updated

June 26, 2023

Sponsor

Hillel Grossman

Collaborators

National Center for Complementary and Integrative Health (NCCIH)

1. Study Identification

Unique Protocol Identification Number

NCT02033941

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

June 2023

Overall Recruitment Status

Suspended

Why Stopped

Study has been suspended for the duration of the pandemic. We hope to re-start enrollment later this year

Study Start Date

July 3, 2018 (Actual)

Primary Completion Date

March 2024 (Anticipated)

Study Completion Date

March 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Hillel Grossman

Collaborators

National Center for Complementary and Integrative Health (NCCIH)

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Alzheimer's Disease

Keywords

Alzheimer's Disease, Grapeseed Extract, Clinical Trial, Meganatural-AZ, anti-oligomerization, Phase 2, Dietary Supplement, Nutraceutical

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Meganatural-Az Grapeseed Extract

Arm Type

Active Comparator

Arm Description

Meganatural-Az® doses: 30mg / day for 2 weeks; 4 weeks of 600 mg/day, 4 weeks 1000mg / day

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Subjects receive capsules identical in appearance to the active agent with the same incremental schedule

Intervention Type

Drug

Intervention Name(s)

Meganatural-Az Grapeseed Extract

Other Intervention Name(s)

Grapeseed Polyphenolic Extract, Grapeseed Phenol Extract, GSPE

Intervention Description

Meganatural-Az® doses: 30mg / day for 2 weeks; 4 weeks of 600 mg/day, 4 weeks 1000mg / day

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Subjects receive capsules identical in appearance to the active agent with the same incremental schedule

Primary Outcome Measure Information:

Title

pharmacokinetic analysis

Description

the pharmacokinetics and effects of Meganatural-Az® on tau and abnormally phosphorylated tau CSF concentrations

Time Frame

up to 22 months

Title

primary safety evaluations

Description

adverse effects reporting

Time Frame

up to 22 months

Secondary Outcome Measure Information:

Title

AD Biomarkers

Description

β-amyloid (Aβ) in plasma and in cerebral spinal fluid (CSF) specimens

Time Frame

up to 22 months

Title

cognitive and functional assessments

Description

cognitive and functional assessments including the ADAS-cog, ADCS CGIC, MMSE, and ADL.

Time Frame

up to 22 months

10. Eligibility

Sex

All

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Hillel Grossman, MD

Organizational Affiliation

Mount Sinai School of Medcine

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Samuel Gandy, MD/PhD

Organizational Affiliation

Icahn School of Medicine at Mount Sinai

Official's Role

Principal Investigator

Facility Information:

Facility Name

Mount Sinai Alzheimer's Disease Research Center

City

New York

State/Province

New York

ZIP/Postal Code

10029

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Links:

URL

http://icahn.mssm.edu/research/adrc/research/clinical-trials

Description

Related Info

Learn more about this trial

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

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