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COMPLETED
NCT02947893
PHASE2

Impact of Nilotinib on Safety, Biomarkers and Clinical Outcomes in Mild to Moderate Alzheimer's Disease

Sponsor: Georgetown University

View on ClinicalTrials.gov

Summary

The investigators hypothesize that Nilotinib will be safe in individuals with mild to moderate AD. Specifically, investigators hypothesize that low daily oral doses of Nilotinib will lead to CSF penetration, CNS Abl inhibition, and stabilization of CSF total Tau and p-Tau231/181 and Abeta42/40 levels. The investigators hypothesize that Nilotinib will decrease brain load of amyloid using amyloid positron emission tomography (PET). The investigators also predict that Nilotinib will reduce CSF markers of cell death, including neuron specific enolase (NSE) and S100B.

Official title: A Randomized, Double Blind, Placebo-controlled Study to Evaluate the Impact of Low Doses of Nilotinib (Tasigna®) on Safety, Biomarkers and Clinical Outcomes in Subjects With Mild to Moderate Alzheimer's Disease

Key Details

Gender

All

Age Range

50 Years - 85 Years

Study Type

INTERVENTIONAL

Enrollment

37

Start Date

2017-01

Completion Date

2021-03

Last Updated

2026-07-23

Healthy Volunteers

No

Interventions

DRUG

Placebo Capsule(s) Once a Day by Mouth

1 capsule of Placebo once a day for 6 months followed by 2 capsules of Placebo for another 6 months

DRUG

Nilotinib Capsule(s) Once a Day by Mouth

1 capsule of Nilotinib 150 mg once a day for 6 months followed by 2 capsules of Nilotinib (150 mg each capsule = 300 mb total) for the subsequent 6 months

Locations (1)

Georgetown University Medical Center

Washington D.C., District of Columbia, United States