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CERE-110 in mild to moderate Alzheimer's disease
NCT00876863Phase 2
Key facts
- Status
- Completed
- Start
- Nov 2008
- Primary completion
- Aug 2015
- Countries
- 1
- Sponsor
- Sangamo Therapeutics
- Modality
- Gene Editing, Gene Silencing, Nucleic Acid Therapeutics
- Drugs
- CERE-110
- Conditions
- Alzheimer's disease (AD)
01
Overview
Phase 2, randomised, double-blind trial in Alzheimer's disease (AD) comparing CERE-110 with Placebo (2 arms). Primary endpoint: Alzheimer's Disease Assessment Scale - Cognitive Subscale at 24 months. Started Nov 2008; status: completed.
02
Design
2 arms- Study design
- RandomizedDouble-blind
CERE-110
CERE-110 injection
Placebo
Sham surgery
03
Who it enrols
Patients aged 55-80 with mild to moderate Alzheimer's disease, on stable approved medications for at least 3 months, and medically able to undergo neurosurgery.
04
Endpoints
Primary
Alzheimer's Disease Assessment Scale - Cognitive Subscale
Secondary
Neuropsychological Test Battery
Mini-Mental State Examination
Neuropsychiatric Inventory
Alzheimer's Disease Cooperative Study - Activities of Daily Living
05
Results
Not all primary endpoints met
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