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

StatusRecruiting
PhasePhase 1
Started
View on ClinicalTrials.gov ↗

Record History

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  1. Trial sites expanded: 1 → 4 locationsv4
  2. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 1
    • Start date changed from estimate of Jan 2026 to Jan 30, 2026
    v3
  3. Eligibility criteria revised
    • Primary endpoint revised
    v2
  4. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT07328451
Lead Sponsor Denali Therapeutics Inc.
Conditions
(from sponsor)		 Alzheimer Disease, Early Onset
Related terms Alzheimer Disease
Enrollment 68 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov