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Also known as MTAU9937A, RO7105705
Semorinemab · 2 trials · 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. |
| Multiple Dose Placebo IV | PLACEBO_COMPARATOR | Healthy participants or participants with Alzheimer's disease will receive multiple doses of matching placebo IV QW, a total of 4 doses. |
| Multiple Dose RO7105705 IV | EXPERIMENTAL | Healthy participants or participants with Alzheimer's disease will receive multiple doses of RO7105705 IV QW, a total of 4 doses. |
| Single Dose RO7105705 SC | EXPERIMENTAL | Healthy participants will receive a single dose of RO7105705 SC on Day 1. |
| Single dose Placebo IV | PLACEBO_COMPARATOR | Healthy participants will receive a single dose of placebo IV on Day 1. |
| Single dose RO7105705 IV | EXPERIMENTAL | Healthy participants will receive a single dose of RO7105705 IV on Day 1. |
| 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. |
| RO7105705 | DRUG | Participants will receive single or multiple doses of RO7105705 IV or SC. |
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 monoclonal antibody being studied for the treatment of Alzheimer's disease. It was evaluated in a Phase 2 clinical trial in patients with moderate Alzheimer's disease. Semorinemab is not approved for any indication and remains in clinical development.
Semorinemab targets MAPT, the gene encoding the tau protein. It is designed as an inhibitor of tau, a protein that forms neurofibrillary tangles in Alzheimer's disease. By targeting tau, semorinemab aims to interfere with tau pathology, though its clinical benefit has not been established.
Semorinemab is being developed by Roche Holding AG, which trades under the ticker RHHBY. Roche conducted the clinical development of semorinemab for Alzheimer's disease.
Semorinemab is in Phase 2 development. A Phase 2 trial in moderate Alzheimer's disease has been completed. Semorinemab is investigational and has not been approved by the FDA or any regulatory agency for any indication.
Semorinemab was evaluated in a completed Phase 2 trial, NCT03828747, titled A Study of Semorinemab in Patients With Moderate Alzheimer's Disease. The trial enrolled 272 participants across the United States, France, Poland, and Spain. It was randomized, double-blind, and placebo-controlled.