A randomized phase 1b/2 trial of ABBV‐916 in adults with early Alzheimer's disease
Shau Yu Lynch, Yamin Wang, Deli Wang, Sagar S Bachhav, Hao Xiong, Joey Boiser, Edwin Stage, Anthony W Bannon, Ole Graff, Hana FlorianAbstract
INTRODUCTION
ABBV‐916, an anti‐amyloid immunotherapy, was evaluated in patients with early Alzheimer's disease (AD).
METHODS
This phase 1b/2, double‐blind, placebo‐controlled study consisted of two stages: multiple ascending dose (Stage A) and dose expansion (Stage B). In Stage A, patients were randomized to one of six planned cohorts to receive intravenous ABBV‐916 (10 mg to 3000 mg) or placebo monthly through week 24. Assessments included amyloid PET, blood‐based biomarkers, pharmacokinetics (PK), and safety. Dose selection for Stage B was to be based on results from Stage A.
RESULTS
One hundred six patients were randomized to ABBV‐916 or placebo. The 3000 mg dose was reduced to 2000 mg and subsequently to 900 mg after safety review. Dose‐proportional PK were observed, and amyloid reduction was observed over 24 weeks at doses ≥300 mg. Most adverse events were non‐serious amyloid‐related imaging abnormalities. The program ended before dose expansion due to business considerations.
DISCUSSION
Amyloid clearance rate and safety of ABBV‐916 were generally comparable to approved anti‐amyloid AD therapies.
CLINICAL TRIAL REGISTRATION INFORMATION
NCT05291234