Actively Recruiting
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
Led by Denali Therapeutics Inc. · Updated on 2026-02-23
68
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating DNL628 in people with early Alzheimer's disease, including mild cognitive impairment or mild Alzheimer's with amyloid biomarker evidence. This Phase 1b, multicenter, randomized, placebo-controlled, and double-blind study aims to assess the safety, tolerability, pharmacokinetics, and pharmacodynamics of DNL628. The trial focuses on participants with early Alzheimer's defined by clinical dementia rating and cognitive test scores. Participants will receive multiple ascending doses of either DNL628 or a placebo during the double-blind period lasting 37 weeks. The study includes randomized assignment to experimental or placebo groups with careful monitoring throughout. The design allows comparison of drug effects and safety against placebo over time. During the 37 weeks, researchers will monitor treatment-emergent adverse events and measure drug levels in plasma to understand how DNL628 is processed by the body. They will also assess changes in biomarkers related to Alzheimer's disease in cerebrospinal fluid over 25 weeks. This comprehensive assessment includes clinical evaluations and laboratory tests to ensure participant safety and study integrity throughout the trial duration.
CONDITIONS
Brief 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...
- Age between 18 and 75 years
- Body mass index (BMI) of 18 to less than 32 kg/m2
- Body weight of at least 45 kg
- Diagnosis of probable Alzheimer's disease dementia based on NIA AA 2011 criteria, including amnestic or nonamnestic presentation
- Supportive evidence of Alzheimer's pathology with amyloid positivity via historical records or lab testing
- Alzheimer's severity defined by Clinical Dementia Rating global score of 0.5 or 1
- Mini-Mental State Examination score between 20 and 30 inclusive
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 significant medical conditions that may interfere with study assessments
- History of malignancy within 5 years before screening except fully resected basal cell carcinoma or low-risk malignancies agreed upon by investigator and medical monitor
- Previous anti-amyloid or anti-tau immunotherapy, including active immunization (except certain allowed passive immunotherapy with agreement)
- Previous exposure to gene therapy
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 37 weeks
Participants receive multiple ascending doses of the study drug or placebo to evaluate safety, tolerability, pharmacokinetics, and pharmacodynamics.
Regular visits during dosing period
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
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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