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Also known as RO7126209, RG6102
Trontinemab · 5 trials · 2 indications
An Adverse Event (AE) is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An Adverse Event can therefore be any unfavorable and unintended sign (including abnormal laboratory values or abnormal clinical test results), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as Adverse Events.
| Arm | Type | Description |
|---|---|---|
| Trontinemab | EXPERIMENTAL | Participants will receive intravenous (IV) trontinemab. |
| Placebo | PLACEBO_COMPARATOR | Participants will receive IV placebo. |
| Part 1 (Dose Finding) Cohort 1: Dose Level 1 of RO7126209 | EXPERIMENTAL | Participants will receive multiple doses of RO7126209 at dose level 1 once every 4 weeks (Q4W) for 28 weeks followed by a 28-week safety follow-up period. |
| Part 1 (Dose Finding) Cohort 1: Placebo | PLACEBO_COMPARATOR | Participants will receive matching placebo to dose level 1 Q4W for 28 weeks followed by a 28-week safety follow-up period. |
| Part 1 (Dose Finding) Cohort 2: Dose Level 2 of RO7126209 | EXPERIMENTAL | Participants will receive multiple doses of RO7126209 at dose level 2, Q4W, for 28 weeks followed by a 28-week safety follow-up period. |
| Part 1 (Dose Finding) Cohort 2: Placebo | PLACEBO_COMPARATOR | Participants will receive matching placebo to dose level 2, Q4W, for 28 weeks followed by a 28-week safety follow-up period. |
| Part 1 (Dose Finding) Cohort 3: Dose Level 3 of RO7126209 | EXPERIMENTAL | Participants will receive multiple doses of RO7126209 at dose level 3, Q4W, for 28 weeks followed by a 28-week safety follow-up period. |
| Part 1 (Dose Finding) Cohort 3: Placebo | PLACEBO_COMPARATOR | Participants will receive matching placebo to dose level 3, Q4W, for 28 weeks followed by a 28-week safety follow-up period. |
| Part 1 (Dose Finding) Cohort 4: Dose Level 4 of RO7126209 | EXPERIMENTAL | Participants will receive multiple doses of RO7126209 at dose level 4, Q4W, for 28 weeks followed by a 28-week safety follow-up period. |
| Part 1 (Dose Finding) Cohort 4: Placebo | PLACEBO_COMPARATOR | Participants will receive matching placebo to dose level 4, Q4W, for 28 weeks followed by a 28-week safety follow-up period. |
| Part 1 (Dose Finding) Cohort 5: Dose Level 5 of RO7126209 | EXPERIMENTAL | Participants will receive a total of 2 doses of RO7126209 at dose level 5 Q4W, for 28 weeks followed by an 8-week safety follow-up period. |
| Part 1 (Dose Finding) Cohort 5: Placebo | PLACEBO_COMPARATOR | Participants will receive a total of 2 doses of matching placebo to dose level 5 Q4W, for 28 weeks followed by an 8-week safety follow-up period. |
| Part 2 (Expansion) Cohort 1: Dose Level 3 of RO7126209 | EXPERIMENTAL | Participants will receive multiple doses of RO7126209 at dose level 3, Q4W, for 28 weeks followed by a 28-week safety follow-up period. |
| Part 2 (Expansion) Cohort 1: Placebo | PLACEBO_COMPARATOR | Participants will receive matching placebo to dose level 3, Q4W, for 28 weeks followed by a 28-week safety follow-up period. |
| Part 2 (Expansion) Cohort 2: Dose Level 4 of RO7126209 | EXPERIMENTAL | Participants will receive multiple doses of RO7126209 at dose level 4, Q4W, for 28 weeks followed by a 28-week safety follow-up period. |
| Part 2 (Expansion) Cohort 2: Placebo | PLACEBO_COMPARATOR | Participants will receive matching placebo to dose level 4, Q4W, for 28 weeks followed by a 28-week safety follow-up period. |
| Part 2 (Expansion) Cohort 3: Dose Level 5 of RO7126209 | EXPERIMENTAL | Participants will receive a total of 2 doses of RO7126209 at dose level 5, Q4W, for 28 weeks followed by an 8-week safety follow-up period. |
| Part 2 (Expansion) Cohort 3: Placebo | PLACEBO_COMPARATOR | Participants will receive a total of 2 doses of matching placebo to dose level 5, Q4W, for 28 weeks followed by an 8-week safety follow-up period. |
| Part 3 (Dose/Frequency/Pharmacodynamic (PD) Relationship): Dose Level 1: RO7126209 | EXPERIMENTAL | Participants will receive multiple doses of RO7126209 in an open-label treatment period at dose level 1, Q4W, for 24 weeks followed by a 28-week safety follow-up period. |
| Part 3 Dose/Frequency/PD Relationship: Dose Level 2: RO7126209 | EXPERIMENTAL | Participants will receive multiple doses of RO7126209 in an open-label treatment period at dose level 2, Q12W, for 24 weeks followed by a 28-week safety follow-up period. |
| Part 4: Open Label Extension (OLE) | EXPERIMENTAL | Participants who completed Part 1, 2, or 3 will receive RO7126209 for a maximum of 205 weeks. |
| RO7126209 (0.1 mg/kg) | EXPERIMENTAL | Healthy volunteers will be administered a single intravenous dose of RO7126209 (0.1 mg/kg). |
| RO7126209 (0.4 mg/kg) | EXPERIMENTAL | Healthy volunteers will be administered a single intravenous dose of RO7126209 (0.4 mg/kg). |
| RO7126209 (1.2 mg/kg) | EXPERIMENTAL | Healthy volunteers will be administered a single intravenous dose of RO7126209 (1.2 mg/kg). |
| RO7126209 (3.6 mg/kg) | EXPERIMENTAL | Healthy volunteers will be administered a single intravenous dose of RO7126209 (3.6 mg/kg). |
| RO7126209 (7.2 mg/kg) | EXPERIMENTAL | Healthy volunteers will be administered a single intravenous dose of RO7126209 (7.2 mg/kg). |
| Name | Type | Description |
|---|---|---|
| Trontinemab | DRUG | Participants will receive IV trontinemab. |
| Placebo | DRUG | Participants will receive IV placebo. |
| RO7126209 | DRUG | RO7126209 will be administered intravenously as specified in each treatment arm. |
Inclusion Criteria: * Body weight of 150 kg or less * Willingness and ability to complete all aspects of the study for the duration of the study * Adequate visual and auditory acuity, in the investigator's judgment, sufficient to perform the neuropsychological testing (eyewear and hearing aids are ...
Trontinemab is an investigational monoclonal antibody being developed for Alzheimer's disease. It is being studied in early symptomatic Alzheimer's disease and in cognitively unimpaired individuals at risk of progression to symptomatic Alzheimer's disease. It is not approved for any use and remains in clinical development.
Trontinemab is a monoclonal antibody, a targeted biologic designed to bind a specific molecular target. It is being developed for Alzheimer's disease, and its antibody format allows selective engagement of that target. The clinical program evaluates its safety, tolerability, pharmacokinetics, and pharmacodynamics in participants with Alzheimer's disease.
Trontinemab is being developed by Roche Holding AG, which trades under the ticker RHHBY. Roche is running the clinical program, including Phase 3 studies in early symptomatic Alzheimer's disease and in cognitively unimpaired individuals at risk of progression to symptomatic Alzheimer's disease.
Trontinemab is in Phase 3 clinical development for Alzheimer's disease. It has not been approved by the FDA or any other regulatory agency and is considered investigational. The Phase 3 program includes randomized, double-blind, placebo-controlled trials, and a Phase 1 multiple ascending dose study has also been conducted.
Trontinemab is being studied in several clinical trials. Phase 3 studies include NCT07717411 in cognitively unimpaired individuals at risk of progression to symptomatic Alzheimer's disease, plus NCT07170150 and NCT07169578 in early symptomatic Alzheimer's disease. The Phase 1 Brainshuttle AD study is NCT04639050. These trials together have enrolled about 4,038 participants.
Yes, Trontinemab is also known as RO7126209. RO7126209 is the internal Roche development code used in earlier studies, including the Phase 1 Brainshuttle AD trial NCT04639050. Both names refer to the same investigational monoclonal antibody being developed by Roche for Alzheimer's disease.