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Also known as Semorinemab, RG6100, MTAU9937A
RO7105705 · 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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RO7105705 is an investigational small molecule being developed for the treatment of Alzheimer's Disease. It is currently in Phase 1 clinical development and has not been approved by regulatory authorities. The drug is being studied in patients with mild-to-moderate Alzheimer's Disease, as well as in healthy participants.
RO7105705 is being developed by Roche Holding AG, which trades under the ticker RHHBY. The company is conducting clinical trials to evaluate the safety and tolerability of this investigational small molecule for Alzheimer's Disease. Roche is responsible for the drug's development program.
RO7105705 is in Phase 1 clinical development. A Phase 1 study has been completed, which evaluated the drug in healthy participants and participants with mild-to-moderate Alzheimer's Disease. The drug is investigational and has not been approved for any use.
RO7105705 has one completed clinical trial registered as NCT02820896, titled "A Study of RO7105705 in Healthy Participants and Participants With Mild-to-Moderate Alzheimer's Disease." This Phase 1 study enrolled 74 participants in the United States and was a randomized, double-blind, placebo-controlled trial.
RO7105705 is not FDA approved. It is an investigational drug currently in Phase 1 clinical development for Alzheimer's Disease. The completed Phase 1 trial was designed to assess safety and tolerability, and further studies would be needed before any regulatory approval could be considered.