A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of DNL628 in Participants With Early Alzheimer's Disease
Condition(s) studied
Investigational drug(s) / intervention(s)
DNL628: Multiple ascending doses
Placebo: Multiple ascending doses
Study 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.
Note: In the Netherlands, this study includes an open-label extension.
Eligibility
Primary outcome measure(s)
- Incidence and severity of treatment-emergent adverse events (TEAEs) throughout the double-blind period — 37 weeks
Trial sites (4)
| Facility | City | Region | Status |
|---|---|---|---|
| Clinical Site(s) | 's-Hertogenbosch | Netherlands | Recruiting |
| Clinical Site(s) | Amsterdam | Netherlands | Recruiting |
| Clinical Site(s) | Zwolle | Netherlands | Recruiting |
| Clinical Site(s) | London | United Kingdom | Recruiting |
More Denali Therapeutics Inc. trials in the UK
Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT07328451 on ClinicalTrials.gov ↗ ← All trials in the UK