Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
RO4602522 · 4 trials · 2 indications
| 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. |
| Part A: Placebo | PLACEBO_COMPARATOR | - |
| Part A: RO4602522 | EXPERIMENTAL | - |
| Part B: RO4602522 Multiple Doses | EXPERIMENTAL | - |
| Part B: RO4602522 Single Dose | EXPERIMENTAL | - |
| Part B: moxifloxacin Single Dose | EXPERIMENTAL | - |
| RO4602522 | ACTIVE_COMPARATOR | - |
| RO4602522 + ketoconazole | EXPERIMENTAL | - |
| Single Arm | EXPERIMENTAL | - |
| 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 |
| Placebo RO4602522 | OTHER | Daily oral doses |
| moxifloxacin | DRUG | 400 mg oral dose given on Day 1 or 11 |
| moxifloxacin placebo | OTHER | Dose given orally on Days 1 and/or 11 |
| ketoconazole | DRUG | Multiple oral doses |
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 being studied for Alzheimer's disease. It has been evaluated in a Phase 2 clinical trial in participants with moderate severity Alzheimer's disease who were on background Alzheimer's disease therapy. The drug has also been studied in healthy volunteers in earlier-phase trials.
RO4602522 is being developed by Roche Holding AG, which trades under the ticker RHHBY. Roche has sponsored clinical trials of the drug in healthy volunteers and in patients with Alzheimer's disease.
RO4602522 has completed a Phase 2 clinical trial for Alzheimer's disease. It is an investigational drug and remains in clinical development. Earlier Phase 1 trials in healthy volunteers have also been completed.
RO4602522 has been studied in three completed clinical trials. These include NCT01625806 and NCT01631422, which were Phase 1 studies in healthy male volunteers, and NCT01677754, a Phase 2 study in participants with moderate Alzheimer's disease. All three trials are completed.
RO4602522 is the drug name used in clinical trial records. No alternative names have been associated with this drug in the available information.