Approval Probability
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Adjusted LOA
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Semorinemab · 1 trial · 1 indication
The Alzheimer's Disease Assessment Scale, Cognitive Subscale, 11-Item Version (ADAS-Cog11) is an 11 item cognitive subscale used to quantify the areas of cognitive function most often affected in Alzheimer's disease. The total score ranges from 0-70 with lower scores indicating better cognitive function.
The Alzheimer's Disease Cooperative Study-Daily Living Inventory (ADCS-ADL) is a scale used to quantify performance of activities of daily living (ADL). Scores on the ADCS-ADL range from 0-78, with higher scores indicating better ADL function.
| Arm | Type | Description |
|---|---|---|
| Semorinemab | EXPERIMENTAL | Semorinemab will be administered intravenously in the double-blind treatment period, and semorinemab will be administered intravenously in the optional open-label extension period. |
| Placebo | PLACEBO_COMPARATOR | Placebo will be administered intravenously in the double-blind treatment period and semorinemab will be administered intravenously in the optional open-label extension. |
| Name | Type | Description |
|---|---|---|
| Semorinemab | DRUG | Participants will receive semorinemab every 2 weeks (Q2W) for the first three doses of the double-blind treatment period and every 4 weeks (Q4W) thereafter during the double-blind treatment period. Semorinemab will be administered Q4W in the OLE period. |
| Placebo | DRUG | Participants will receive placebo every 2 weeks (Q2W) for the first three doses of the double-blind treatment period and every 4 weeks (Q4W) thereafter during the double-blind treatment period. |
| [18F]GTP1 | DRUG | \[18F\]GTP1 will be administered as a solution for intravenous (IV) use, as part of positron emission tomography (PET) imaging. |
Inclusion Criteria: * National Institute on Aging/Alzheimer's Association core clinical criteria for probable AD dementia * Evidence of the AD pathological process, by a positive amyloid assessment either on CSF Aβ1-42 as measured on Elecsys β-Amyloid(1-42) Test System OR amyloid PET scan * AD deme...
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Semorinemab is an investigational small molecule being studied for the treatment of Alzheimer's Disease. It is currently in Phase 2 clinical development and is not yet approved by regulatory authorities. The drug is being evaluated in patients with moderate Alzheimer's Disease.
Semorinemab is being developed by Roche Holding AG, a multinational healthcare company. Roche's stock is traded under the ticker symbol RHHBY. The company is conducting clinical trials to evaluate the safety and efficacy of Semorinemab in patients with Alzheimer's Disease.
Semorinemab is currently in Phase 2 clinical development. A Phase 2 study of the drug has been completed, involving 272 participants with moderate Alzheimer's Disease. The drug is investigational and has not yet received approval from regulatory agencies.
Semorinemab has one completed clinical trial registered under NCT03828747, titled 'A Study of Semorinemab in Patients With Moderate Alzheimer's Disease'. This Phase 2 study enrolled 272 participants across the United States, France, Poland, and Spain. The trial was randomized, double-blind, and placebo-controlled.
Semorinemab is not FDA approved. It is an investigational drug currently in Phase 2 clinical development for Alzheimer's Disease. A Phase 2 clinical trial has been completed, but the drug has not yet received regulatory approval and remains under investigation.