KeifeRx, LLC
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.
Alzheimer Disease
Nilotinib BE 84mg
Nilotinib BE 112 mg
Placebo
Phase 3
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.}}
Study Type : | Interventional |
Estimated Enrollment : | 1275 participants |
Masking : | Quadruple |
Masking Description : | Double-Blind |
Primary Purpose : | Treatment |
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) |
Actual Study Start Date : | February 1, 2022 |
Estimated Primary Completion Date : | December 31, 2025 |
Estimated Study Completion Date : | June 1, 2026 |
Arm | Intervention/treatment |
---|---|
Placebo Comparator: Arm A: Placebo 425 subjects will be randomized to the placebo group. |
Drug: Placebo |
Active Comparator: Arm B: Experimental Low Dose 425 subjects to each of the Nilotinib BE, 84mg. |
Drug: Nilotinib BE 84mg |
Active Comparator: Arm C: Experimental High Dose 425 subjects to each of the Nilotinib BE, 112mg. |
Drug: Nilotinib BE 112 mg |
Ages Eligible for Study: | 55 Years to 85 Years |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Accepts Healthy Volunteers |
Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.