A randomized phase 1b/2 trial of ABBV-916 in adults with early Alzheimer's disease

ABBV-916, an anti-amyloid immunotherapy, was evaluated in patients with early Alzheimer's disease (AD).

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.

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.

Amyloid clearance rate and safety of ABBV-916 were generally comparable to approved anti-amyloid AD therapies.

NCT05291234.