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DNL628

Phase 1

Alzheimer Disease, Early Onset | Small molecule | Neurology |Denali Therapeutics Inc.|Last Updated: Jul 1, 2026

Success Probability
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Market & Valuation
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Trial Design
RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment68
FDA Designations
No designations recorded
Clinical trial landscape

DNL628 · 1 trial · 1 indication

Phase 1 1
NCT07328451A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of DNL628 in Participants With Early Alzheimer's DiseaseAlzheimer Disease, Early Onset
RECRUITING68 Analytics
PHASE1RECRUITING
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of DNL628 in Participants With Early Alzheimer's Disease
Alzheimer Disease, Early Onset
NCT0732845168
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Study Endpoints
Primary Endpoints
Incidence and severity of treatment-emergent adverse events (TEAEs) throughout the double-blind period
37 weeks
Secondary Endpoints
PK parameter: Maximum concentration (Cmax) of DNL628 in plasma
37 weeks
PK Parameter: Time to reach maximum concentration (tmax) of DNL628 in plasma
37 weeks
PK Parameter: Minimum concentration (Cmin) of DNL628 in plasma
37 weeks
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelSEQUENTIAL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Experimental ArmEXPERIMENTAL -
Placebo ArmPLACEBO_COMPARATOR -
Interventions
NameTypeDescription
DNL628DRUGMultiple ascending doses
PlaceboDRUGMultiple ascending doses
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Eligibility Criteria
Age Range18 Years to 75 Years
SexALL
Healthy VolunteersNo
Study Sites4

Key Inclusion Criteria: * BMI of ≥18 to \< 32 kg/m2 and body weight of ≥45 kg * Have a diagnosis of probable AD dementia based on NIA AA 2011 criteria, including amnestic or nonamnestic presentation at screening * Have supportive evidence of AD pathology via historical records or laboratory testing...

Countries:NetherlandsUnited Kingdom
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Recent Changes (Last 90 Days)
LOWJul 2, 2026NCT07328451lastUpdatePostDate: changed
LOWJul 2, 2026NCT07328451lastUpdatePostDate: changed
LOWJul 2, 2026NCT07328451lastUpdatePostDate: changed
LOWJul 2, 2026NCT07328451lastUpdatePostDate: changed
LOWMay 26, 2026NCT07328451primaryCompletionDate: changed
LOWMay 24, 2026NCT07328451studyFirstPostDate: changed