Impact of Nilotinib on Safety, Tolerability, Pharmacokinetics and Biomarkers in Dementia With Lew… (NCT04002674) | Clinical Trial Compass
CompletedPhase 2
Impact of Nilotinib on Safety, Tolerability, Pharmacokinetics and Biomarkers in Dementia With Lewy Bodies
United States43 participantsStarted 2019-07-01
Plain-language summary
Dementia with Lewy Bodies (DLB) is an alphasynucleinopathy and the second most common form of dementia in the elderly. DLB shares striking neuropathological and clinical similarities with both Parkinson's disease (PD) and Alzheimer's disease (AD). Nilotinib (Tasigna®, AMN107, Novartis, Switzerland) is approved by the FDA and is well tolerated for CML treatment at oral doses of 600-800mg daily. The Investigators propose to perform a phase II randomized, double blinded, placebo controlled study to evaluate the impact of Nilotinib in patients with DLB.
Who can participate
Age range25 Years – 90 Years
SexALL
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Inclusion criteria
✓. Written informed consent
✓. Capable of providing informed consent and complying with study procedures. Subjects who are unable to provide consent may use a Legally Authorized Representative (LAR).
✓. Clinical diagnosis of DLB according to McKeith et al (7) with both dementia MoCA≥18 and Parkinsonian defined as bradykinesia in combination with rest tremor, rigidity or both UPDRS I-III is less than 50 and/or UPDRS-III between 15 -40 on-state. Dementia and Parkinsonism must be present with at least one other symptom such as fluctuation, visual hallucinations or REM sleep behavioral disorder (RBD)
✓. 2.5 ≥Hoehn and Yahr stage ≤3
✓. MDS-UPDRS-III 15-40 on-state (or up to 70 on the off state)
✓. Abnormal DaTScan
✓. Stable concomitant medical and/or psychiatric illnesses in the judgement of the PI
✓. Patients between the age of 25-90 years, medically stable
Exclusion criteria
What they're measuring
1
Safety and Tolerability: Occurrence of Adverse Events (AEs)
. Patients with hypokalemia, hypomagnesaemia, or long QT syndrome- QTc≥461 ms
✕. Concomitant drugs known to prolong the QTc interval and history of any cardiovascular disease, including myocardial infraction or cardiac failure, angina, arrhythmia
✕. History or presence of cardiac conditions including:
✕. Cardiovascular or cerebrovascular event (e.g. myocardial infarction, unstable angina, or stroke)
✕. Congestive heart failure
✕. First, second- or third-degree atrioventricular block, sick sinus syndrome, or other serious cardiac rhythm disturbances
✕. Any history of Torsade de Pointes
✕. Treatment with any of the following drugs at the time of screening or the preceding 30 days, and/or planned use over the course of the trial: