NCT07328451 A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of DNL628 in Participants With Early Alzheimer's Disease
| NCT ID | NCT07328451 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Denali Therapeutics Inc. |
| Condition | Alzheimer Disease, Early Onset |
| Study Type | INTERVENTIONAL |
| Enrollment | 68 participants |
| Start Date | 2026-01-30 |
| Primary Completion | 2027-02 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 68 participants in total. It began in 2026-01-30 with a primary completion date of 2027-02.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
Key Inclusion Criteria: * 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) Key Exclusion Criteria: * 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 * 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
Contact & Investigator
Medical Monitor
STUDY DIRECTOR
Denali Therapeutics
Frequently Asked Questions
Who can join the NCT07328451 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Alzheimer Disease, Early Onset. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07328451 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT07328451 currently recruiting?
Yes, NCT07328451 is actively recruiting participants. Contact the research team at clinical-trials@dnli.com for enrollment information.
Where is the NCT07328451 trial being conducted?
This trial is being conducted at 's-Hertogenbosch, Netherlands, Amsterdam, Netherlands, Zwolle, Netherlands, London, United Kingdom.
Who is sponsoring the NCT07328451 clinical trial?
NCT07328451 is sponsored by Denali Therapeutics Inc.. The principal investigator is Medical Monitor at Denali Therapeutics. The trial plans to enroll 68 participants.
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