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NCT03752294 · Status: WITHDRAWN · Phase: PHASE1 · Type: INTERVENTIONAL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

No results posted yet for this study

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

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
  • Boehringer Ingelheim

    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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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03752294 on ClinicalTrials.gov