RecruitingPhase 1NCT07328451

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

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


Sponsor

Denali Therapeutics Inc.

Enrollment

68 participants

Start Date

Jan 30, 2026

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is testing an investigational drug called DNL628 in people with early-stage Alzheimer's disease. Researchers are evaluating how safe the drug is, how the body processes it, and how it interacts with the biological markers of Alzheimer's disease in the brain. **You may be eligible if...** - You have a diagnosis of probable Alzheimer's disease based on recognized criteria - Your Alzheimer's is at an early stage — mild cognitive impairment or early dementia (Clinical Dementia Rating global score of 0.5 or 1, and MMSE score of 20–30) - You have evidence of Alzheimer's amyloid pathology from historical records or screening tests - Your BMI is between 18 and 32 and you weigh at least 45 kg **You may NOT be eligible if...** - You have another neurological or cognitive condition besides Alzheimer's - You have significant psychiatric conditions - You have unstable or poorly controlled medical conditions (heart, lung, liver, kidney, or hormonal) - You have had another cancer within the past 5 years (with some exceptions for low-risk cancers) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGDNL628

Multiple ascending doses

DRUGPlacebo

Multiple ascending doses


Locations(1)

Clinical Site(s)

London, United Kingdom

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NCT07328451


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