Trial reportAlzheimer's & dementia : the journal of the Alzheimer's Association2026
A randomized phase 1b/2 trial of ABBV-916 in adults with early Alzheimer's disease.
Trial report in Alzheimer's & dementia : the journal of the Alzheimer's Association, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05291234 (A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Efficacy, Pharmacokinetics and Pharmacodynamics of ABBV-916 in Subjects With Early Alzheimer's Disease), which is not on this map. Not yet cited in PubMed.
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The trial behind it
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A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Efficacy, Pharmacokinetics and Pharmacodynamics of ABBV-916 in Subjects With Early Alzheimer's Disease
Who cites it
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Authors and funding
10 authors.
Funding
Abstract
introductionABBV-916, an anti-amyloid immunotherapy, was evaluated in patients with early Alzheimer's disease (AD).
methodsThis 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.
resultsOne 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.
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