Evaluating the Efficacy and Safety of Nilotinib BE in Subjects With Early Alzheimer's Disease (NILEAD)

Evaluating the Efficacy and Safety of Nilotinib BE in Subjects With Early Alzheimer's Disease (NILEAD)

ClinicalTrials.gov ID: NCT05143528
Sponsor: KeifeRx, LLC
Information provided by: KeifeRx, LLC (Responsible Party)
Last Update Posted: 2021-12-03

Brief Summary:
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.

Detailed Description:
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.

Official Title:
A Multicenter, Phase III, Randomized, Double Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Nilotinib BE in Subjects With Early Alzheimer's Disease (NILEAD)

Intervention / Treatment:
- Drug: Nilotinib BE 84mg
- Drug: Nilotinib BE 112 mg
- Drug: Placebo

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