Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Gantenerumab · 3 trials · 1 indication
An 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 an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. SAE is any adverse event that is fatal or which requires or prolongs inpatient hospitalization or results in persistent or significant disability/incapacity or causes congenital anomaly/birth defect or results in a significant medical event in the investigator's judgment.
Participants were considered positive or negative for ADA based on their baseline and post-baseline sample results. The number and percentage of participants with confirmed positive ADA levels were determined for participants previously (in part 1) on Gantenerumab and Placebo. The prevalence of ADA at baseline was calculated as the percentage of participants with confirmed positive ADA levels at baseline relative to the total number of participants with a sample available at baseline. The incidence of treatment-emergent ADAs was determined as the percentage of participants with confirmed post-baseline positive ADAs relative to the total number of participants that had at least one post-baseline sample available for ADA analysis.
Percentage of participants with adverse events leading to discontinuation from treatment were reported.
The CDR (Clinical Dementia Rating) is obtained through semi-structured interviews of participants and informants, and cognitive functioning is rated in six domains of functioning: memory, orientation, judgement and problem solving, community affairs, home and hobbies, and personal care. Each domain is rated on a five-point scale of functioning as follows: 0, no impairment; 0.5, questionable impairment; 1, mild impairment; 2, moderate impairment; and 3, severe impairment. The CDR-SOB (Clinical Dementia Rating-Sum of Boxes) is based on summing each of the domain box scores with total scores ranging from 0-18, where lower total scores represent better outcomes and higher total scores represent worse outcomes.
An Adverse Event 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 an abnormal laboratory finding, for example), 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 |
|---|---|---|
| Part 1 (Double Blind treatment): Placebo | PLACEBO_COMPARATOR | Participants received matching placebo by subcutaneous (SC) injection every 4 weeks (Q4W) up to 100 weeks during Part 1 of the study. |
| Part 1 (Double Blind treatment): Gantenerumab | EXPERIMENTAL | Participants received 105 mg Gantenerumab by SC injection Q4W for 24 weeks and if eligible 225 mg SC injection Q4W from weeks 28-100 during Part 1 of the study. |
| Part 2 (Open-Label Extension [OLE] treatment): Placebo switched to Gantenerumab Up to 1200 mg | PLACEBO_COMPARATOR | Participants who had received Placebo in Part 1, received Gantenerumab at doses up to 1200 mg by SC injection Q4W for up to 2 years. Additionally, participants were given the option to continue receiving open-label gantenerumab treatment for 3 years. |
| Part 2 (OLE treatment): Gantenerumab up to 1200 mg | EXPERIMENTAL | Participants who had received Gantenerumab in Part 1, received treatment at doses up to 1200 mg by SC injection Q4W for up to 2 years. Additionally, participants were given the option to continue receiving open-label gantenerumab treatment for 3 years. |
| Placebo (Parts 1 and 2) | PLACEBO_COMPARATOR | Participants with Alzheimer's disease received Placebo by SC injection every 4 weeks (Q4W) for 104 weeks or approximately 2 years during Part 1 of the study. Participants who completed the Week 104 visit were given an option to continue the treatment received during Part 1, for 2 additional years in Part 2. |
| Gantenerumab 105 mg (Parts 1 and 2) | EXPERIMENTAL | Participants with Alzheimer's disease received Gantenerumab 105 mg by SC injection every 4 weeks (Q4W) for 104 weeks or approximately 2 years during Part 1 of the study. Participants who completed the Week 104 visit were given an option to continue the treatment received during Part 1, for 2 additional years in Part 2. |
| Gantenerumab 225 mg (Parts 1 and 2) | EXPERIMENTAL | Participants with Alzheimer's disease received Gantenerumab 225 mg by SC injection every 4 weeks (Q4W) for 104 weeks or approximately 2 years during Part 1 of the study. Participants who completed the Week 104 visit were given an option to continue the treatment received during Part 1, for 2 additional years in Part 2. |
| Placebo (Parts 1 and 2) switched to Gantenerumab Up to 1200mg (Part 3 Open-Label Extension [OLE]) | PLACEBO_COMPARATOR | Participants with Alzheimer's disease who had received Placebo by SC injection in Part 1 or Part 2, now received Gantenerumab at doses up to 1200 mg by SC injection every 4 weeks (Q4W) for up to 5 additional years. |
| Gantenerumab Up to 1200 mg (Part 3 Open-Label Extension [OLE]) | EXPERIMENTAL | Participants with Alzheimer's disease who had received Gantenerumab by SC injection in Part 1 or Part 2, now received Gantenerumab at doses up to 1200 mg by SC injection every 4 weeks (Q4W) for up to 5 additional years. |
| 1 | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| Placebo | DRUG | Participants received Placebo SC injection Q4W. |
| Gantenerumab | DRUG | Participants received Gantenerumab at 105 mg , 225 mg, or at doses up to 1200 mg SC injection Q4W. |
Inclusion Criteria: * Clinical diagnosis of probable mild Alzheimer disease (AD) based on National Institute of Neurological and Communicative Disorders and Stroke/Alzheimer's Disease and Related Disorders Association (NINCDS/ADRDA) criteria or major NCD based whether or not receiving AD approved m...
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Gantenerumab is an investigational monoclonal antibody being studied for the treatment of Alzheimer's disease. It has been evaluated in clinical trials involving participants with mild Alzheimer's disease and prodromal Alzheimer's disease. It is not approved for any indication.
Gantenerumab targets amyloid precursor protein (APP). It is a monoclonal antibody designed to bind APP, the protein from which amyloid beta is derived. This mechanism is intended to address amyloid pathology associated with Alzheimer's disease. The target class is a binding agent.
Gantenerumab is being developed by Roche Holding AG, which trades under the ticker RHHBY. Roche is the sponsor of the clinical trials evaluating the drug in Alzheimer's disease.
Gantenerumab has been studied in Phase 3 clinical trials for Alzheimer's disease. Three trials are listed, all completed, including two Phase 3 studies and one Phase 1 study. The drug remains investigational and is not approved for any indication.
Gantenerumab has been evaluated in three completed clinical trials: NCT02051608, a Phase 3 study in mild Alzheimer's disease with 389 participants; NCT01224106, a Phase 3 study in prodromal Alzheimer's disease with 799 participants; and NCT00531804, a Phase 1 multiple ascending dose study with 60 participants.
Yes, Gantenerumab was previously known as R1450. The Phase 1 multiple ascending dose study NCT00531804 was conducted under the name R1450 in patients with Alzheimer's disease. Gantenerumab is the current name for this monoclonal antibody.