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Nilotinib BE

Phase 3

Alzheimer Disease | Small molecule | Neurology |Lantheus Holdings, Inc.|Last Updated: Dec 3, 2021

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedDouble-BlindPLACEBO_CONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment1,275
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT05143528Evaluating the Efficacy and Safety of Nilotinib BE in Subjects With Early Alzheimer's DiseasePHASE3 NOT YET_RECRUITING 1,275Feb 1, 2022Jun 1, 2026Dec 3, 2021 -
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Study Endpoints
Primary Endpoints
Changes From Baseline in Clinical Dementia Rating Scale - Sum of Boxes (CDR-SB) Score at Week 72 [ Time Frame: Baseline, Week 72]
72 weeks

CDR-SB integrates assessments from 3 domains of cognition (memory, orientation, judgment/problem-solving) and 3 domains of function (community affairs, home/hobbies, personal care). Following a systematic patient examination, the rater assigns a score describing the participant's current performance level in each of these domains of life functioning. Prespecified severity anchors range from none = 0, questionable = 0.5, mild = 1, moderate = 2 to severe = 3 (the personal care domain omits the 0.5 score). "Sum of boxes" scoring methodology sums the score for each of the 6 domains and provides a value ranging from 0 to 18 that can change in increments of 0.5 or greater. Higher scores indicate greater disease severity. A positive change from baseline indicates clinical decline.

Secondary Endpoints
Change From Baseline in Alzheimer's Disease Assessment Scale-Cognitive Subscale (14 Items) (ADAS-Cog 14) at Week 72
72 weeks
Change From Baseline in Mini Mental State Examination (MMSE) Score at Week 72
72 weeks
Change From Baseline in Alzheimer's Disease Cooperative Study-Activities of Daily Living Inventory (Mild Cognitive Impairment Version) (ADCS-ADL-MCI) Score at Week 72
72 weeks
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Study Design & Arms
AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Arm A: PlaceboPLACEBO_COMPARATOR425 subjects will be randomized to the placebo group.
Arm B: Experimental Low DoseACTIVE_COMPARATOR425 subjects to each of the Nilotinib BE, 84mg.
Arm C: Experimental High DoseACTIVE_COMPARATOR425 subjects to each of the Nilotinib BE, 112mg.
Interventions
NameTypeDescription
Nilotinib BE 84mgDRUG84 mg capsule
Nilotinib BE 112 mgDRUG112 mg capsule
PlaceboDRUGplacebo capsule
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Eligibility Criteria
Age Range55 Years — 85 Years
SexALL
Healthy VolunteersYes

Inclusion Criteria: * 1- Diagnosis of dementia due to AD 2- Meet the National Institute of Aging-Alzheimer's Association (NIA-AA) core clinical criteria for dementia due to AD 3- 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 4-...

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Recent Changes (Last 90 Days)
LOWMay 24, 2026NCT05143528studyFirstPostDate: changed