NCT02033941

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

Terminated Phase 2 Last updated 15 October 2024

What this trial tests

Phase 2 trial testing Meganatural-Az Grapeseed Extract in Alzheimer's Disease in 10 participants. Terminated before completion.

Timeline

3 July 2018

Primary endpoint
4 October 2019

4 October 2019

Quick facts

Lead sponsor	Hillel Grossman
Phase	Phase 2
Status	Terminated
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	10
Start date	3 July 2018
Primary completion	4 October 2019
Estimated completion	4 October 2019
Sites	1 location across United States

Drugs / interventions tested

• Meganatural-Az Grapeseed Extract — full drug profile →
• Placebo

Conditions studied

• Alzheimer's Disease — all drugs for Alzheimer's Disease →

Sponsor

Hillel Grossman — full company profile →

Who can join

Eligibility, any sex, with Alzheimer's Disease. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Alzheimer's disease drug development pipeline: 2019.
   Cummings J, Lee G, Ritter A, Sabbagh M, et al · · 2019 · cited 485× · PMID 31334330 · DOI 10.1016/j.trci.2019.05.008
2. Alzheimer's disease drug development pipeline: 2022.
   Cummings J, Lee G, Nahed P, Kambar MEZN, et al · · 2022 · cited 369× · PMID 35516416 · DOI 10.1002/trc2.12295
3. Alzheimer's disease drug development pipeline: 2020.
   Cummings J, Lee G, Ritter A, Sabbagh M, et al · · 2020 · cited 350× · PMID 32695874 · DOI 10.1002/trc2.12050
4. Alzheimer's disease drug development pipeline: 2021.
   Cummings J, Lee G, Zhong K, Fonseca J, et al · · 2021 · cited 312× · PMID 34095440 · DOI 10.1002/trc2.12179
5. Pathological mechanisms and therapeutic strategies for Alzheimer's disease.
   Ju Y, Tam KY. · · 2022 · cited 260× · PMID 34380884 · DOI 10.4103/1673-5374.320970
6. The Potential Use of Plant Natural Products and Plant Extracts with Antioxidant Properties for the Prevention/Treatment of Neurodegenerative Diseases: In Vitro, In Vivo and Clinical Trials.
   Pohl F, Kong Thoo Lin P. · · 2018 · cited 159× · PMID 30544977 · DOI 10.3390/molecules23123283
7. Oxidative Stress, Neuroinflammation, and NADPH Oxidase: Implications in the Pathogenesis and Treatment of Alzheimer's Disease.
   Ganguly U, Kaur U, Chakrabarti SS, Sharma P, et al · · 2021 · cited 86× · PMID 33953837 · DOI 10.1155/2021/7086512
8. Roles of Oxidative Stress in Synaptic Dysfunction and Neuronal Cell Death in Alzheimer's Disease.
   Plascencia-Villa G, Perry G. · · 2023 · cited 84× · PMID 37627623 · DOI 10.3390/antiox12081628