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RECRUITING
NCT07328451
PHASE1

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

Sponsor: Denali Therapeutics Inc.

View on ClinicalTrials.gov

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.

Official title: A Phase 1b, Multicenter, Randomized, Placebo-Controlled, Double-Blind Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of DNL628 in Participants With Early Alzheimer's Disease

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

68

Start Date

2026-01-30

Completion Date

2027-02

Last Updated

2026-02-23

Healthy Volunteers

No

Interventions

DRUG

DNL628

Multiple ascending doses

DRUG

Placebo

Multiple ascending doses

Locations (1)

Clinical Site(s)

London, United Kingdom