Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01035138 | A Study of Semagacestat for Alzheimer's Patients | PHASE3 | COMPLETED | 180 | — | — | Dec 1, 2009 | Apr 1, 2011 | Sep 25, 2014 | 71 | United States, Australia +12 |
The cognitive subscale of the ADAS (ADAS-Cog11) consists of 11 items assessing areas of function most typically impaired in Alzheimer's Disease (AD): orientation, verbal memory, language, and praxis. The scale ranges from 0 to 70, with higher scores indicating greater disease severity.
The ADCS-ADL is a 23-item inventory developed as a rater-administered questionnaire answered by the participant's caregiver. It measures both basic and instrumental activities of daily living. The total score ranges from 0 to 78, with lower scores indicating greater disease severity.
| Arm | Type | Description |
|---|---|---|
| Drug: semagacestat | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| semagacestat | DRUG | 140mg administered orally, once daily for 24 months; dose reduction to 100mg or 60 mg possible due to intolerability |
Inclusion Criteria: * Meets National Institute of Neurological and Communicative Disorders and Stroke/Alzheimer's Disease and Related Disorders Association (NINCDS/ADRDA) criteria for probable Alzheimer's Disease * Completed semagacestat study LFAN or study LFBC through 88 weeks * Must continue to ...