A Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of DNL921 in Healthy Participants and Participants With Alzheimer's Disease

This is a Phase 1/1b, multicenter, randomized, placebo-controlled, double-blind study to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of single and multiple doses of DNL921 in healthy participants and participants with Alzheimer's disease (AD). The principal aim of this study is to obtain safety and tolerability data. This information, together with PK and PD data, will inform dose selection and design of future studies.

NCT Number	NCT07758595
Lead Sponsor	Denali Therapeutics Inc.
Conditions	Alzheimer's Disease, Healthy Participants
Enrollment	178 participants
Start Date	2026-08
Primary Completion	2030-04 (estimated)
Study Completion	2030-04 (estimated)
Updated on ClinicalTrials.gov	2026-08-11