Clinical Trial

A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of DNL628 in Participants With Early Alzheimer's Disease

Recruiting Phase 1
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Summary
This is a Phase 1b, multicenter, randomized, placebo-controlled, double-blind, multiple ascending dose (MAD) study to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of DNL628 in participants with early Alzheimer's disease (AD), defined as mild cognitive impairment, or mild AD with biomarker evidence of amyloid positivity. Note: In the Netherlands, this study includes an open-label extension.
Protocol Amendment History 1 change
notable Trial sites expanded: 1 -> 4 locations 2026-07-02
Trial Details
NCT Number NCT07328451
Lead Sponsor Denali Therapeutics Inc.
Conditions Alzheimer Disease, Early Onset
Enrollment 68 participants
Start Date 2026-01-30
Primary Completion 2027-02 (estimated)
Study Completion 2027-02 (estimated)
Updated on ClinicalTrials.gov 2026-07-01