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Bapineuzumab SC in mild to moderate Alzheimer's Disease
NCT01254773Phase 2
Key facts
- Status
- Completed
- Start
- Dec 2010
- Primary completion
- Jan 2013
- Countries
- 1
- Sponsor
- Janssen Pharmaceutical
- Modality
- Monoclonal Antibodies
- Drugs
- bapineuzumab
- Conditions
- Alzheimer's disease (AD)
01
Overview
Phase 2, randomised, double-blind trial of bapineuzumab in Alzheimer's disease (AD) (4 arms), sponsored by Janssen Pharmaceutical. Primary endpoint: Cerebral amyloid burden as measured by PET at 24 months. Started Dec 2010; status: completed.
02
Design
4 arms- Study design
- RandomizedDouble-blind
Bapineuzumab 2 mg
Bapineuzumab 2 mg SC monthly
Bapineuzumab 7 mg
Bapineuzumab 7 mg SC monthly
Bapineuzumab 20 mg
Bapineuzumab 20 mg SC monthly
Placebo
Placebo SC monthly
03
Who it enrols
Patients aged 50-89 with probable Alzheimer's disease, MMSE 18-26, and amyloid burden on PET scan. Excludes significant neurological/psychiatric disease, stroke/seizure history, and autoimmune disease.
04
Endpoints
Primary
Cerebral amyloid burden as measured by PET
Secondary
Safety and tolerability
Cognitive and functional endpoints
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