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RO7812653 · 1 trial · 1 indication
C-SSRS measures 4 constructs as follows: severity of ideation, intensity of ideation, behavior, and lethality of actual suicide attempts. Binary (yes/no) data are collected for 10 categories. Numeric ratings are provided for intensity of ideation (if present), from 1 to 5, with 1 being the least severe and 5 being the most severe.
| Arm | Type | Description |
|---|---|---|
| RO7812653 | EXPERIMENTAL | Participants will receive a dose of RO7812653 |
| Placebo | PLACEBO_COMPARATOR | Participants will receive a dose of placebo |
| Name | Type | Description |
|---|---|---|
| RO7812653 | DRUG | Participants will receive RO7812653 as per the schedule in the protocol |
| Placebo | DRUG | Participants will receive placebo as per the schedule in the protocol |
Inclusion Criteria: * Probable AD dementia (consistent with National Institute on Aging and Alzheimer's Association (NIA-AA) core clinical criteria for probable AD dementia) \[McKhann et al 2011\] or Mild Cognitive Impairment (MCI) due to AD (consistent with the NIA-AA core clinical criteria for mi...
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RO7812653 is an investigational small molecule being developed for the treatment of early symptomatic Alzheimer's Disease (eAD). It is currently in Phase 1 clinical development and is not yet approved by regulatory authorities. The drug is being studied to evaluate its safety, tolerability, pharmacokinetics, and pharmacodynamics in patients with this condition.
RO7812653 is being developed by Roche Holding AG, a multinational healthcare company. Roche's stock is traded under the ticker symbol RHHBY on the OTC market. The company is conducting clinical trials to investigate the potential of RO7812653 as a treatment for early symptomatic Alzheimer's Disease.
RO7812653 is currently in Phase 1 clinical development. It is an investigational drug, meaning it has not been approved by the FDA or other regulatory agencies. The ongoing Phase 1 trial is designed to assess the safety, tolerability, pharmacokinetics, and pharmacodynamics of RO7812653 in participants with early symptomatic Alzheimer's Disease.
RO7812653 is being studied in one active Phase 1 clinical trial with the identifier NCT07234942. This trial is titled 'A Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of RO7812653 in Participants With Early Symptomatic Alzheimer's Disease (eAD)'. The study is currently active but not recruiting participants, with an enrollment of 6 patients.
No, RO7812653 is not FDA approved. It is an investigational drug currently in Phase 1 clinical development for early symptomatic Alzheimer's Disease. The drug is being evaluated in a randomized, double-blind, placebo-controlled trial to assess its safety, tolerability, pharmacokinetics, and pharmacodynamics. Regulatory approval has not been granted.