BENITIONSClinical Trial Intelligence

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

Phase 2 Completed NCT02947893

ConditionAlzheimer's Disease
PhasePhase 2
SponsorGeorgetown University
StatusCompleted
Enrollment37 participants
InterventionsPlacebo Capsule(s) Once a Day by Mouth, Nilotinib Capsule(s) Once a Day by Mouth
Start dateJan, 2017
Completion dateDec, 2020
Results postedJul 23, 2026

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.

Safety Will be Measured by Number of Participants Experiencing the Occurrence of Adverse Events and/or Abnormal Laboratory Values

12 months · events

Group 1 (Placebo)2 events
Group 2 (Treated)0 events
Group 1 (Placebo)1 events
Group 2 (Treated)1 events
Group 1 (Placebo)1 events
Group 2 (Treated)0 events

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