Impact of Nilotinib on Safety, Biomarkers and Clinical Outcomes in Mild to Moderate Alzheimer's Dā¦ (NCT02947893) | Clinical Trial Compass
CompletedPhase 2
Impact of Nilotinib on Safety, Biomarkers and Clinical Outcomes in Mild to Moderate Alzheimer's Disease
United States37 participantsStarted 2017-01
Plain-language 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.
Who can participate
Age range50 Years ā 85 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
ā. Age ā„ 50
ā. Fluent in English
ā. Biomarker confirmed AD with CSF level of Abeta42 \<600ng/mL
ā. Able to ingest oral medications
ā. Diagnosis of mild to moderate AD according to dementia criteria outlined by McKhann et al.
ā. Neuroimaging (MRI or CT) consistent with the diagnosis of AD within the past year
ā. MMSE between 17 and 24 (inclusive) at screening
ā. Modified Hachinski score ā¤ 4
Exclusion criteria
ā. Non-AD dementia, probable AD with Down syndrome, APP, PS-1, or PS-2 mutations (known familial AD), LBD and Fronto-temporal dementia (FTD)
ā. History of clinically significant stroke
ā
What they're measuring
1
Safety will be measured by number of participants experiencing the occurrence of adverse events and/or abnormal laboratory values
. Current evidence or history in past two years of epilepsy, focal brain lesion, head injury with loss of consciousness or DSM-IV criteria for any major psychiatric disorder including psychosis, major depression, bipolar disorder, alcohol or substance abuse
ā. Sensory impairment that would preclude participation/cooperation with the protocol
ā. Patients with hypokalemia, hypomagnesaemia, or long QTc syndrome.
ā. Concomitant drugs known to prolong the QTc interval (\>461ms) and history of cardiovascular disease, including myocardial infarction or cardiac failure, angina, arrhythmia
ā. Prescribed strong CYP3A4 inhibitors or a medical history of liver or pancreatic disease
ā. Evidence of any significant clinical disorder or laboratory finding that renders the participant unsuitable for receiving an investigational drug including clinically significant or unstable hematologic, hepatic, cardiovascular, pulmonary, gastrointestinal, endocrine, metabolic, renal or other systemic disease or laboratory abnormality