Number of Subjects: Approximately 1275 subjects will be randomized 1:1:1 across Nilotinib BE, 84mg or 112mg or matching placebo~Number of Centers: Approximately 50 centers US-Wide~Duration of Study: Enrollment will be (competitive) opened for 3 years (36 months) and total study duration is approximately 5 years~Core Study: Approximately 425 subjects will be randomized to the placebo group (arm A) and 425 subjects to each of the Nilotinib BE, 84mg (arm B) and 112mg (arm C) groups.~Biomarker Sub-study: Approximately 180 subjects (60 subjects per group) will be randomized for the CSF biomarker sub-study at Baseline and 18 months (Week 72).~Approximately 164 subjects (48 per group) will be randomized to the imaging sub-studies, including amyloid PET, tau PET and vMRI, at Baseline and 18 months (week 72).~Eligible subjects are diagnosed with dementia due to AD according to the National Institute of Aging-Alzheimer's Association (NIA-AA) core clinical criteria for early AD. Participants must have a global CDR score of 0.5 to 1.0 and a CDR Memory Box score of 0.5 or greater at Screening and Baseline and/or MMSE score greater than or equal to 20 at Screening and Baseline and less than or equal to 27 at Screening and Baseline. Male or female subjects aged ≥55 and ≤ 85 years, at the time of IC.
This study will investigate the safety and efficacy of a Tyrosine Kinase Inhibitor (TKI) called Nilotinib BE (bioequivalent) in individuals with Early Alzheimer's disease (EAD). This is a multi-center double blinded, Phase 3 study, that will enroll patients for three years in approximately 50 centers nationwide. The total duration of the study will be for five years.