ClinicaliQ Trial Snapshot
- A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of DNL628 in Participants With Early Alzheimer’s Disease — Recruiting • Phase I • Respiratory / COPD / Asthma • NCT07328451.
- Drug Being Tested: DNL628 is a novel therapeutic agent undergoing Phase 1b evaluation for safety, tolerability, pharmacokinetics and pharmacodynamics in early Alzheimer's disease using a multiple ascending dose design in a randomized, placebo-controlled trial.
- Patient Eligibility: The trial enrolls participants with early Alzheimer's disease, specifically those with mild cognitive impairment or mild dementia stage disease, allowing assessment of the compound's effects in earlier disease pathology before significant neurodegeneration occurs.
Use This Page For
- Quick orientation before opening the registry record.
- Checking recruitment status, phase and sponsor at a glance.
- Connecting this trial to nearby guidelines, Drug Science and education.
What This Trial Is Studying
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 Snapshot
- 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
Use the source registry for the full inclusion and exclusion criteria before discussing referral or enrolment.