Full results & analysis
Available in the Gosset platform where reported.
Trial intelligence / Profile preview
IDENTITY-2: Semagacestat in Alzheimer's Disease
NCT00762411Phase 3
Key facts
- Status
- Completed
- Start
- Sep 2008
- Primary completion
- Apr 2011
- Countries
- 18
- Sponsor
- Eli Lilly and Company
- Modality
- Peptides, Small Molecules
- Drugs
- semagacestat
- Conditions
- Alzheimer's disease (AD)
01
Overview
Phase 3, randomised, double-blind trial in Alzheimer's disease (AD) comparing LY450139 with Placebo (2 arms). Primary endpoints: Alzheimer's Disease Assessment Scale-Cognitive Subscale (11 items) and Alzheimer's Disease Cooperative Study Activities of Daily Living Inventory. Started Sep 2008; status: completed.
02
Design
2 arms- Study design
- RandomizedDouble-blind
LY450139
Semagacestat 60mg -> 100mg -> 140mg daily.
Placebo
Placebo daily for 76 weeks, then Semagacestat 140mg daily.
03
Who it enrols
Patients with mild to moderate Alzheimer's disease (MMSE 16-26), post-menopausal females, capable of swallowing, with a reliable caregiver. Excludes serious unstable illnesses, chronic alcohol/drug abuse, and prior AD vaccination.
04
Endpoints
Primary
Alzheimer's Disease Assessment Scale-Cognitive Subscale (11 items)
Alzheimer's Disease Cooperative Study Activities of Daily Living Inventory
Secondary
Clinical Dementia Rating Sum of Boxes
Neuropsychiatric Inventory
Resource Utilization in Dementia-Lite
EuroQol 5-Dimensional Health-Related Quality of Life Scale Proxy Version Visual Analog Scale
Quality of Life in Alzheimer's Disease
Mini Mental State Examination
Amyloid Beta 1-42 Plasma Concentration
Positron Emission Tomography Using Fluorine-18 Fluorodeoxyglucose
05
Results
Not all primary endpoints met
Beyond the preview
Go deeper on NCT00762411.
Full results, competitive context and analysis are in the Gosset platform.
Competitive context
Available in the Gosset platform where reported.
Bring the full picture into focus.
See how Gosset can support your research on NCT00762411.