NCT02033941

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Jul 2018

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 9, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 13, 2014

Completed
4.5 years until next milestone

Study Start

First participant enrolled

July 3, 2018

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 4, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 4, 2019

Completed
Last Updated

October 15, 2024

Status Verified

October 1, 2024

Enrollment Period

1.3 years

First QC Date

January 9, 2014

Last Update Submit

October 11, 2024

Conditions

Alzheimer's Disease

Keywords

Alzheimer's DiseaseGrapeseed ExtractClinical TrialMeganatural-AZanti-oligomerizationPhase 2Dietary SupplementNutraceutical

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (2)

  • AD Biomarkers

    up to 22 months

  • cognitive and functional assessments

    up to 22 months

Study Arms (2)

Meganatural-Az Grapeseed Extract

ACTIVE COMPARATOR

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

Drug: Meganatural-Az Grapeseed Extract

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

Meganatural-Az Grapeseed ExtractDRUG

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

Also known as: Grapeseed Polyphenolic Extract, Grapeseed Phenol Extract, GSPE
Meganatural-Az Grapeseed Extract
PlaceboDRUG

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

Placebo

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • Current use of drugs with significant anticholinergic or antihistaminic properties

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mount Sinai Alzheimer's Disease Research Center

New York, New York, 10029, United States

Location

MeSH Terms

Conditions

Alzheimer Disease

Condition Hierarchy (Ancestors)

DementiaBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesTauopathiesNeurodegenerative DiseasesNeurocognitive DisordersMental Disorders

Study Officials

  • Hillel Grossman, MD

    Mount Sinai School of Medcine

    PRINCIPAL INVESTIGATOR

  • Samuel Gandy, MD/PhD

    Icahn School of Medicine at Mount Sinai

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

January 9, 2014

First Posted

January 13, 2014

Study Start

July 3, 2018

Primary Completion

October 4, 2019

Study Completion

October 4, 2019

Last Updated

October 15, 2024

Record last verified: 2024-10

Data Sharing

IPD Sharing
Will not share

Locations

US(1)