A Phase 2 Study to Evaluate Efficacy and Safety of AL002 in Participants With Early Alzheimer's Disease

Summary

A phase 2 randomized, double blind, placebo controlled study evaluating the efficacy and safety of AL002 in participants with Early Alzheimer's Disease.

Timeline

Start

2021-01-22

Primary completion

2024-08-19

Completion

2024-09-12

Outcome

Missed primary endpoint

paper The study did not meet the primary endpoint of change from baseline in the Clinical Dementia Rating-Sum of Boxes score (versus placebo) PMID 41787076 ↗

registry AL002 Dose 3: 60 mg/kg vs Placebo; p = 0.7975; Mean Difference (Final Values) -0.17 (95% CI -1.49 to 1.15) NCT04592874 ↗

Publications

• Mummery CJ, Mayorga AJ, Simmons A, Chow TW, Burgess B, Nguyen T, Gao J, Budda B, Park LQ, Gupta R, Li C, Shi L, Kenkare-Mitra S, Rosenthal A, Paul R, Ward M, Purcell DD, Salloway S, Grundman M, Romano G, Salvadore G. The TREM2 agonistic antibody AL002 in early Alzheimer's disease: a phase 2 randomized trial. Nat Med. 2026 May;32(5):1708-1716. doi: 10.1038/s41591-026-04273-1. Epub 2026 Mar 5.
• Shao Q, Chen S, Zheng Y, Xu W, Chen J, Shao W, Wang Q, Li C, Wang X. Crucial role of microglia-mediated myelin sheath damage in vascular dementia: Antecedents and consequences. Neural Regen Res. 2026 Mar 1;21(3):1000-1012. doi: 10.4103/NRR.NRR-D-24-01109. Epub 2025 Mar 25.
• De Deyn L, Sleegers K. The impact of rare genetic variants on Alzheimer disease. Nat Rev Neurol. 2025 Mar;21(3):127-139. doi: 10.1038/s41582-025-01062-1. Epub 2025 Feb 4.
• Brodtmann A, Darby D, Oboudiyat C, Mahoney CJ, Le Heron C, Panegyres PK, Brew B. Assessing preparedness for Alzheimer disease-modifying therapies in Australasian health care systems. Med J Aust. 2023 Apr 3;218(6):247-249. doi: 10.5694/mja2.51880. Epub 2023 Mar 19. No abstract available.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	AL002	Monoclonal antibody	15 mg/kg	Intravenous
Subject	AL002	Monoclonal antibody	40 mg/kg	Intravenous
Subject	AL002	Monoclonal antibody	60 mg/kg	Intravenous

Indications