Alzheimer's DiseasePhase 2NCT02033941
Phase 2 Study to Examine Grape Seed Extract as an Anti-Oligomerization Agent in Alzheimer's Disease (AD)
A Phase 2 study testing Meganatural-Az Grapeseed Extract in people with Alzheimer's Disease, run by Hillel Grossman at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Alzheimer's Disease
- What is being tested?
- Meganatural-Az Grapeseed Extract
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Jul 2018to 4 Oct 2019
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Mount Sinai Alzheimer's Disease Research Center
New York, New York, 10029
About this study
Official title: 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.
Read the 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.
- Conditions
- Alzheimer's Disease
- Being tested
- Meganatural-Az Grapeseed Extract, Placebo
- Keywords
- Alzheimer's Disease, Grapeseed Extract, Clinical Trial, Meganatural-AZ, anti-oligomerization, Phase 2, Dietary Supplement, Nutraceutical
- Medical subject headings
- Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Meganatural-Az Grapeseed ExtractDrug
Also called Grapeseed Polyphenolic Extract, Grapeseed Phenol Extract, GSPE
Meganatural-Az® doses: 30mg / day for 2 weeks; 4 weeks of 600 mg/day, 4 weeks 1000mg / day
PlaceboDrug
Subjects receive capsules identical in appearance to the active agent with the same incremental schedule
| Study group | Role | What they receive |
|---|---|---|
| Meganatural-Az Grapeseed Extract | Active comparator | Meganatural-Az® doses: 30mg / day for 2 weeks; 4 weeks of 600 mg/day, 4 weeks 1000mg / day Receives: Drug: Meganatural-Az Grapeseed Extract |
| Placebo | Placebo comparator | Subjects receive capsules identical in appearance to the active agent with the same incremental schedule Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
pharmacokinetic analysis
the pharmacokinetics and effects of Meganatural-Az® on tau and abnormally phosphorylated tau CSF concentrations
Measured: up to 22 months
primary safety evaluations
adverse effects reporting
Measured: up to 22 months
Secondary outcomes (2)
AD Biomarkers
β-amyloid (Aβ) in plasma and in cerebral spinal fluid (CSF) specimens
Measured: up to 22 months
cognitive and functional assessments
cognitive and functional assessments including the ADAS-cog, ADCS CGIC, MMSE, and ADL.
Measured: up to 22 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2014 (estimated)
- Study start3 Jul 2018
- Primary completion4 Oct 2019
- Study completion4 Oct 2019
Why it stopped: difficulty with enrollment due to pandemic.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alzheimer's DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hillel Grossman
- Sponsor type
- University, hospital or other
- Collaborators
- National Center for Complementary and Integrative Health (NCCIH)
- Responsible party
- Sponsor-investigator, Hillel Grossman, Icahn School of Medicine at Mount Sinai
- Investigators
- Hillel Grossman, MD, Principal investigator, Mount Sinai School of MedcineSamuel Gandy, MD/PhD, Principal investigator, Icahn School of Medicine at Mount Sinai
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02033941
- Sponsor's protocol ID
- GCO 09-0307
- Other IDs
- 5R21AT005510
- Status last verified
- Oct 2024
- First submitted
- 9 Jan 2014
- Last updated
- 15 Oct 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Grape Seed Extract as Anti-Oligomerization Agent in Alzheimer's Disease
- ClinicalTrials.gov ID
- NCT02033941
- Acronym / sponsor ID
- GCO 09-0307
- Conditions
- Alzheimer's Disease
- Keywords
- Alzheimer's Disease, Grapeseed Extract, Clinical Trial, Meganatural-AZ, anti-oligomerization, Phase 2, Dietary Supplement, Nutraceutical
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: difficulty with enrollment due to pandemic.
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Hillel GrossmanUniversity, hospital or other
- Collaborators
- National Center for Complementary and Integrative Health (NCCIH)
- Study start
- 3 Jul 2018 (actual)
- Primary completion
- 4 Oct 2019 (actual)
- Study completion
- 4 Oct 2019 (actual)
- First posted
- 13 Jan 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Meganatural-Az Grapeseed Extract | Active comparator | Drug: Meganatural-Az Grapeseed ExtractMeganatural-Az® doses: 30mg / day for 2 weeks; 4 weeks of 600 mg/day, 4 weeks 1000mg / day |
| Placebo | Placebo comparator | Drug: PlaceboSubjects receive capsules identical in appearance to the active agent with the same incremental schedule |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (11 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Meganatural-Az Grapeseed ExtractAlso: Grapeseed Polyphenolic Extract, Grapeseed Phenol Extract, GSPEMeganatural-Az® doses: 30mg / day for 2 weeks; 4 weeks of 600 mg/day, 4 weeks 1000mg / day | Drug | Meganatural-Az Grapeseed Extract |
| PlaceboSubjects receive capsules identical in appearance to the active agent with the same incremental schedule | Drug | Placebo |
Primary outcome
pharmacokinetic analysis
Time frame: up to 22 months
the pharmacokinetics and effects of Meganatural-Az® on tau and abnormally phosphorylated tau CSF concentrations
primary safety evaluations
Time frame: up to 22 months
adverse effects reporting
2 secondary outcomes
AD Biomarkers
Time frame: up to 22 months
cognitive and functional assessments
Time frame: up to 22 months
Results and safety
The study was stopped early (reason given: difficulty with enrollment due to pandemic.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hillel Grossman, MD principal investigator
Mount Sinai School of Medcine
Samuel Gandy, MD/PhD principal investigator
Icahn School of Medicine at Mount Sinai
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Meganatural-Az Grapeseed Extract in people with Alzheimer's Disease, run by Hillel Grossman at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 15 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: difficulty with enrollment due to pandemic.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
pharmacokinetic analysis (time frame: up to 22 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2024.