Alzheimer's Disease Education and Referral Center

Nilotinib for Mild to Moderate Alzheimer's Disease

Nilotinib for Mild to Moderate Alzheimer's Disease

Overall Status: 
Recruiting
Brief Description: 
This study will test nilotinib (Tasigna®), a drug approved to treat chronic myeloid leukemia, a type of blood cancer, in people with mild to moderate Alzheimer's disease. The drug is thought to inhibit a specific molecular pathway that affects Alzheimer's biomarkers.
Patient Qualifications: 
Min AgeMax AgeGenderHealthy Volunteers
50 Years
85 Years
All
No
Inclusion Criteria: 
    • Diagnosis of mild to moderate Alzheimer's disease
    • Neuroimaging (MRI or CT scan) result consistent with Alzheimer's within the past year; Mini-Mental State Examination score of 17-24 inclusive
    • Able to take oral medications
    • Caregiver or study partner who has direct contact more than 2 days a week, can come to all visits, and can supervise participant taking study medication
    • Stable medical conditions for 3 months prior to screening; stable medications for 4 weeks prior to screening
    • Stable use of the following medications for 3 months prior to screening is allowed: cholinesterase inhibitors, memantine, vitamin E, estrogens, aspirin, and cholesterol-lowering agents
    • Minimum of 6 years of education or work history sufficient to exclude mental retardation
    • Fluent in English
Exclusion Criteria: 
    • Non-Alzheimer's dementia, Alzheimer's disease with Down syndrome, or familial Alzheimer's disease
    • History of stroke, epilepsy, focal brain lesion, or head injury with loss of consciousness
    • Major psychiatric disorder, including psychosis, depression, or bipolar disorder
    • Alcohol or substance abuse
    • Sensory impairment that would preclude participation
    • Hypokalemia (low potassium), hypomagnesaemia (low magnesium), or long QT syndrome
    • Medications known to disturb how the heart conducts electricity (prolonged QT interval)
    • History of cardiovascular disease, including heart attack, heart failure, angina, and arrhythmia
    • Prescribed strong CYP3A4 inhibitors or history of liver or pancreatic disease
    • Benign or malignant growths or history of cancer within 5 years prior to screening (treated basal or squamous skin cancer or stable prostate cancer are allowed)
    • Contraindications to MRI or lumbar puncture (e.g., pacemaker or taking blood-thinning medication)
    • Evidence of more than four microhemorrhages and/or hemosiderosis
    • Low level of vitamin B12, unless follow-up labs indicate that it is not physiologically significant
    • Enrollment in another trial investigating experimental drug or therapy for Alzheimer's
    • Pregnancy or possible pregnancy
    • HIV-positive
Detailed Description: 

In this study, participants will be randomly assigned to take either nilotinib or a placebo as a capsule taken once a day for the first 6 months, followed by two capsules a day for the next 6 months. Based on preclinical evidence and previous trials of nilotinib for other neurodegenerative diseases, researchers are testing the drug to determine if it can safely inhibit Abl, a molecular pathway linked to Alzheimer's disease. They will also assess if the drug affects cerebrospinal fluid levels of amyloid-beta and tau, two proteins whose harmful forms are features of Alzheimer's, and if the drug can penetrate the blood-brain barrier.

Locations: 
Map Marker CityStateZip CodeStatusPrimary Contact

Geolocation is 38.9156487, -77.0737149

Georgetown University Medical Center
Washington
District of Columbia
20007
Recruiting
Ashot R. Shekoyan
202-687-7591
ars232@georgetown.edu
Charbel E. Moussa
202-687-7328
cem46@georgetown.edu
Lead Sponsor: 
Agency
Georgetown University
Collaborator Sponsor: 
Facility Investigators: 
NameRoleAffiliation
Raymond S. Turner, MD, PhD
Principal Investigator
Georgetown University
Charbel E. Moussa, MD, PhD
Study Director
Georgetown University
Study Contact: 
NamePhoneEmail
Raymond S. Turner, MD, PhD
202-687-7337
Ashot R. Shekoyan, MD, PhD
202-687-7591
Locations
 
 
ClinicalTrials.gov ID 
NCT02947893 (follow link to view full record on ct.gov in new window)
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
Study Start Date: 
January 2017
Study End Date: 
March 2019
Disease Stage: 
Early
Middle
Enrollment: 
42