Testing DNL628 for Safety in People With Early Alzheimer's Disease
Tests DNL628 against a placebo in adults with early Alzheimer's disease.
Plain-language title generated from the registry record
Registry title: A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of DNL628 in Participants With Early Alzheimer's Disease
Key facts
- Where
- 's-Hertogenbosch, Amsterdam, and Zwolle, NetherlandsSee the 3 sites
- Phase
- Phase 1
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 75 years old?
Source: NCT07328451, who can take part
Where in Netherlands
- Brain Research Center Den Bosch B.V.'s-Hertogenbosch, NetherlandsTaking people
- Brain Research Center Amsterdam B.V.Amsterdam, NetherlandsTaking people
- Brain Research Center Zwolle B.V.Zwolle, NetherlandsTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Denali Therapeutics Inc.
- Trial code
- NCT07328451EU 2025-523515-11-00
- Record updated
- 1 July 2026
- Original description
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.Read full original descriptionShow less
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
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.
Inclusion: BMI of ≥18 to < 32 kg/m2 and body weight of ≥45 kg; Have a diagnosis of probable AD dementia based on NIA AA 2011 criteria, including amnestic or nonamnestic presentation at screening; Have supportive evidence of AD pathology via historical records or laboratory testing at screening for amyloid positivity; Have AD severity defined as the following at screening:; A Clinical Dementia Rating global score of 0.5 or 1; A Mini-Mental State Examination score of 20 to 30 (inclusive).
Exclusion: Have had previous anti amyloid or anti tau immunotherapy (including active immunization); Note: ADAD participants who have participated in previous passive anti-amyloid immunotherapy > 6 months previously will be allowed, contingent on investigator and Sponsor agreement; Have had previous exposure to gene therapy; Have clinically significant neurological or cognitive disorders affecting the CNS other than AD, as determined by the investigator; Have clinically significant psychiatric conditions; Have any history of unstable or poorly controlled endocrine, pulmonary, cardiovascular, gastrointestinal, hepatic, hematological, or other significant medical condition that, in the opinion of the investigator, may interfere with the completion or interpretation of study assessment; Have had a malignancy within 5 years before screening, except fully resected basal cell carcinoma or other malignancies (such as prostate cancer) at low risk of recurrence, depending on investigator and medical monitor agreement.