A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of DNL628 in Participants With Early Alzheimer's Disease
Recruiting now · Phase 1 · Has a placebo group
Conditions studied: Alzheimer Disease, Early Onset
In brief
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.
Key facts
- Study ID
- NCT07328451
- Run by
- Denali Therapeutics Inc.
- People needed
- 68
- Starts
- 2026-01-30
- Expected to finish
- 2027-02-01
- Last updated by the study team
- 2026-07-01
Who can join
Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.
Where it is running
- Clinical Site(s) — London, United Kingdom (enrolling)
- Clinical Site(s) — 's-Hertogenbosch, Netherlands (enrolling)
- Clinical Site(s) — Amsterdam, Netherlands (enrolling)
- Clinical Site(s) — Zwolle, Netherlands (enrolling)
Full record on ClinicalTrials.gov
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