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Tyrosine Kinase Inhibitor

Group 2 (treated) for Alzheimer's Disease (AD Trial)

Phase 2
Waitlist Available
Led By Raymond S. Turner, MD, PhD
Research Sponsored by Georgetown University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months
Awards & highlights

AD Trial 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.

Eligible Conditions
  • Alzheimer's Disease

AD Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Safety will be measured by number of participants experiencing the occurrence of adverse events and/or abnormal laboratory values
Secondary outcome measures
Effects of Nilotinib treatment on measurement of Nilotinib in the CSF

AD Trial Design

2Treatment groups
Active Control
Placebo Group
Group I: Group 2 (treated)Active Control1 Intervention
Out of 42 total participants with mild to moderate AD (MMSE=17-24 inclusive) and their study partners that will be recruited and 1:1 randomized, 21 (twenty-one) will be assigned to group 2 treated with 1 capsule (150mg Nilotinib) once a day by mouth for the first 6 months followed by dose escalation to 2 capsules (300mg Nilotinib) once daily by mouth for the subsequent 6 months, every time taken without a meal, for the total study duration of 12 months.
Group II: Group 1 (placebo)Placebo Group1 Intervention
Out of 42 total participants with mild to moderate AD (MMSE=17-24 inclusive) and their study partners that will be recruited and 1:1 randomized, 21 (twenty-one) will be assigned to group 1 and given 1 capsule of a placebo drug by mouth every day for the first 6 months followed by 2 capsules once daily for the subsequent 6 months, every time taken without a meal, for the total duration of the study for 12 months.

Find a Location

Who is running the clinical trial?

Georgetown UniversityLead Sponsor
343 Previous Clinical Trials
136,460 Total Patients Enrolled
Charbel E Moussa, MD, PhDStudy DirectorGeorgetown University
Raymond S. Turner, MD, PhDPrincipal InvestigatorGeorgetown University
1 Previous Clinical Trials
119 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Impact of Nilotinib on Safety, Biomarkers and Clinical Outcomes in Mild to Moderate Alzheimer's Disease
R. Scott Turner 2017. "Impact of Nilotinib on Safety, Biomarkers and Clinical Outcomes in Mild to Moderate Alzheimer's Disease". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02947893.
~5 spots leftby May 2025
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