Open Label Extension Study Evaluating Safety and Tolerability of AAB-003 (PF-05236812) in Subject With Mild to Moderate Alzheimer's Disease

Phase 1 Completed 52 enrolled Pfizer JANSSEN Alzheimer Immunotherapy Research & Development, LLC · collab

Non-randomizedParallel-groupOpen-labelTreatment

Summary

This is a study to evaluate the safety and tolerability of multiple doses of AAB-003 (PF-05236812) in patients with mild to moderate Alzheimer's Disease. Patients who complete study B2601001 may participate in this trial and receive AAB-003 (PF-05236812). Each patient's participation will last approximately 52 weeks.

Timeline

Start: 2011-07
Primary completion: 2014-08
Completion: 2014-08

Publications

Delnomdedieu M, Duvvuri S, Li DJ, Atassi N, Lu M, Brashear HR, Liu E, Ness S, Kupiec JW. First-In-Human safety and long-term exposure data for AAB-003 (PF-05236812) and biomarkers after intravenous infusions of escalating doses in patients with mild to moderate Alzheimer's disease. Alzheimers Res Ther. 2016 Mar 1;8(1):12. doi: 10.1186/s13195-016-0177-y.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	AAB-003	Monoclonal antibody	0.5 mg/kg	Intravenous
Subject	AAB-003	Monoclonal antibody	1 mg/kg	Intravenous
Subject	AAB-003	Monoclonal antibody	2 mg/kg	Intravenous
Subject	AAB-003	Monoclonal antibody	4 mg/kg	Intravenous
Subject	AAB-003	Monoclonal antibody	8 mg/kg	Intravenous

Open Label Extension Study Evaluating Safety and Tolerability of AAB-003 (PF-05236812) in Subject With Mild to Moderate Alzheimer's Disease

Summary

Timeline

Publications

Drugs

Indications