Actively Recruiting
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of DNL628 in Participants With Early Alzheimer's Disease
Led by Denali Therapeutics Inc. · Updated on 2026-02-23
68
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of DNL628 in Participants With Early Alzheimer's Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- BMI of 6518 to < 32 kg/m2 and body weight of 6545 kg
- Diagnosis of probable Alzheimer's disease dementia based on NIA AA 2011 criteria
- Supportive evidence of Alzheimer's disease pathology through amyloid positivity at screening
- Alzheimer's disease severity defined by Clinical Dementia Rating global score of 0.5 or 1
- Mini-Mental State Examination score between 20 and 30 (inclusive) at screening
You will not qualify if you...
- Clinically significant neurological or cognitive disorders affecting the central nervous system other than Alzheimer's disease
- Clinically significant psychiatric conditions
- History of unstable or poorly controlled endocrine, pulmonary, cardiovascular, gastrointestinal, hepatic, hematological, or other major medical conditions that may interfere with study assessments
- History of malignancy within 5 years before screening, except fully removed basal cell carcinoma or other low-risk malignancies
- Previous anti-amyloid or anti-tau immunotherapy, including active immunization, except for prior passive anti-amyloid immunotherapy over 6 months ago with approval
- Previous exposure to gene therapy
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Clinical Site(s)
London, United Kingdom, WC1N 3BG
Actively Recruiting
Research Team
C
Clinical Trials at Denali Therapeutics
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
2
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