Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
RO5313534 · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| Placebo | PLACEBO_COMPARATOR | - |
| RO5313534 15mg | EXPERIMENTAL | - |
| RO5313534 1mg | EXPERIMENTAL | - |
| RO5313534 5mg | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| Placebo | DRUG | po daily for 24 weeks |
| RO5313534 | DRUG | 1mg po daily for 24 weeks |
Inclusion Criteria: * adult patients, \>/=50 years of age; * probable Alzheimer's disease; * MMSE score at screening of 13-22; * under stable donepezil treatment given at a fixed dose of 5 or 10mg daily for \>=4 months prior to baseline; * not requiring nursing home care, but looked after by a care...
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RO5313534 is an investigational small molecule developed by Roche Holding AG for Alzheimer's disease. It was studied as an add-on therapy to donepezil in patients with mild to moderate Alzheimer's disease. It is a Phase 2 clinical candidate and has not been approved for any indication.
RO5313534 was studied for the treatment of mild to moderate Alzheimer's disease, specifically as an add-on to existing donepezil treatment. The clinical program enrolled patients aged 50 years and older with a diagnosis of mild to moderate Alzheimer's disease across multiple countries.
RO5313534 is developed by Roche Holding AG, which trades under the ticker RHHBY. Roche sponsored the Phase 2 clinical study of the compound in Alzheimer's disease.
RO5313534 is in Phase 2 development. It is an investigational small molecule and is not FDA approved. The single Phase 2 trial in Alzheimer's disease has been completed, and no active trials are currently listed for this compound.
RO5313534 was evaluated in one Phase 2 trial, NCT00884507, titled A Study of RO5313534 as Add-on to Donepezil Treatment in Patients With Mild to Moderate Alzheimer's Disease. The trial enrolled 389 patients, was placebo controlled and double blind, and has been completed.
The Phase 2 trial of RO5313534, NCT00884507, was conducted across the United States, Argentina, Australia, Canada, France, Germany, Italy, Mexico, Poland, Romania, Slovakia, Spain, and the United Kingdom. It enrolled 389 patients aged 50 years and older with mild to moderate Alzheimer's disease.