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.
• 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)