A Novel Therapeutic Target for Alzheimer's Disease in Men and Women 50-85 Years of Age.
NCT03752294 · Status: WITHDRAWN · Phase: PHASE1 · Type: INTERVENTIONAL
Last updated 2025-04-17
Summary
A randomized-control, double-blind, multi-center, delayed-start, pilot trial evaluating the disease modifying effects of a 150mg once-a-day dose vs. placebo of dabigatran in men and women, between the ages of 50-85 years, confirmed with MCI probably due to AD and mild Alzheimer's Disease.
Conditions
- Mild Cognitive Impairment
- Mild Alzheimer's Disease
Interventions
- DRUG
-
Dabigatran
At the end of a 9-month randomized-control, double-blind treatment all study participants will cross-over to the 12-month open-label phase with a 3-month non-treatment follow-up.
- DRUG
-
Placebo - Cap
At the end of a 9-month randomized-control, double-blind treatment all study participants will cross-over to the 12-month open-label phase with a 3-month non-treatment follow-up
Sponsors & Collaborators
-
Alzheimer's Drug Discovery Foundation
collaborator OTHER - collaborator INDUSTRY
-
University of Rhode Island
lead OTHER
Principal Investigators
-
Paula Grammas, PhD · Executive Director of the Ryan Institute for Neuroscience
-
John Stoukides, MD · Medical Director, Rhode Island Mood & Memory Research Institute
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- QUADRUPLE
- Model
- CROSSOVER
Eligibility
- Min Age
- 50 Years
- Max Age
- 85 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2019-05-31
- Primary Completion
- 2022-05-31
- Completion
- 2022-05-31
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