Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
RO4602522 · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| Placebo | PLACEBO_COMPARATOR | Participants will receive placebo as add-on to a background therapy of AChEI (donepezil, rivastigmine, or galantamine) alone or in combination with memantine. |
| RO4602522 1 milligram (mg) | EXPERIMENTAL | Participants will receive RO4602522 1 mg as add-on to a background therapy of AChEI (donepezil, rivastigmine, or galantamine) alone or in combination with memantine. |
| RO4602522 5 mg | EXPERIMENTAL | Participants will receive RO4602522 5 mg as add-on to a background therapy of AChEI (donepezil, rivastigmine, or galantamine) alone or in combination with memantine. |
| Name | Type | Description |
|---|---|---|
| RO4602522 | DRUG | Participants will receive RO4602522 orally once daily for 12 months. |
| Placebo | DRUG | Participants will receive placebo for RO4602522 orally once daily for 12 months. |
| Donepezil | DRUG | Stable dose as background medication |
| Memantine | DRUG | Stable dose as background medication in combination with AChEIs |
| Rivastigmine | DRUG | Stable dose as background medication |
| Galantamine | DRUG | Stable dose as background medication |
Inclusion Criteria: * Probable Alzheimer disease, based on the National Institute of Neurological and Communicative Disorders and Stroke (NINCDS)/Alzheimer's Disease and Related Disorders Association (ADRDA) and Diagnostic and Statistical Manual of Mental Disorders-Fourth Edition (DSM-IV-TR) criter...
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RO4602522 is an investigational small molecule developed by Roche Holding AG for Alzheimer's disease. It is a Phase 2 candidate that has been studied in a completed placebo-controlled trial in participants with moderate severity Alzheimer's disease who were on background Alzheimer's disease therapy.
RO4602522 is being developed for the treatment of Alzheimer's disease. Its only reported clinical trial enrolled participants with moderate severity Alzheimer's disease who were receiving background Alzheimer's disease therapy, and it has not been approved for any use.
RO4602522 is made by Roche Holding AG, which trades under the ticker RHHBY. Roche is the developer of the compound and sponsored the Phase 2 clinical trial that evaluated it in Alzheimer's disease.
RO4602522 is in Phase 2 development. Its single reported trial, NCT01677754, was a Phase 2 study that has been completed. The drug is investigational and has not been approved by the FDA or any other regulatory agency.
RO4602522 has been studied in one clinical trial, NCT01677754, titled A Study of RO4602522 in Participants With Moderate Severity Alzheimer Disease on Background Alzheimer Disease Therapy. It was a completed Phase 2, randomized, double-blind, placebo-controlled trial that enrolled 542 participants across the United States, Australia, Canada, Czechia, France, Germany, Italy, Poland, South Korea, Spain, Sweden, and the United Kingdom.