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Gantenerumab · 2 trials · 3 indications
Multivariate Disease Progression Model adjusted for Estimated Years to Onset (EYO)and includes all timepoints up to treatment discontinuation. The treatment effect is reported relative to the mutation positive placebo arm. Multivariate Cognitive Endpoint comprising: (i) Wechsler Memory Scale-Revised Logical Memory Delayed Recall Test (MEMUNITS), (ii) Wechsler Adult Intelligence Scale Digit Symbol Substitution Test (WAIS), (iii) Mini-Mental State Examination (MMSE), and (iv) International Shopping List Task (ISLT). Measurements for each test were normalized using the mean (SD) at DIAN-TU-001 baseline for mutation negative subjects. Higher scores indicate more favourable cognitive performance.
The DIAN-Multivariate Cognitive Endpoint (DIAN-MCE) consists of 4 cognitive measures: Wechsler Memory Scale-Revised Logical Memory Delayed Recall Test, Wechsler Adult Intelligence Sale Digit Symbol Substitution Test (WAIS), International Shopping List Task (ISLT), Mini-Mental State Examination (MMSE)
| Arm | Type | Description |
|---|---|---|
| Gantenerumab | EXPERIMENTAL | - |
| Solanezumab | EXPERIMENTAL | - |
| Matching placebo (Gantenerumab) | PLACEBO_COMPARATOR | - |
| Matching Placebo (Solanezumab) | PLACEBO_COMPARATOR | - |
| Cognitive Run-in | NO_INTERVENTION | This arm is completed and closed. |
| Gantenerumab Open Label Extension | ACTIVE_COMPARATOR | Subcutaneously every 4 weeks at escalating doses. This arm is completed and closed. |
| E2814 plus lecanemab | EXPERIMENTAL | Symptomatic Population (Cohort 1) At Week 0, participants will receive open-label lecanemab administered intravenously for the full treatment period. At Week 24, participants randomized to E2814 will receive intravenously in a blinded fashion for the remainder of their treatment period. Asymptomatic Population (Cohort 2) At Week 0, participants randomized to E2814 will receive intravenously in a blinded fashion for the full treatment period. At Week 52, all participants will initiate open-label lecanemab administered intravenously for the remainder of their treatment period. |
| Matching placebo (E2814) plus lecanemab | EXPERIMENTAL | Symptomatic Population (Cohort 1) At Week 0, participants will receive open-label lecanemab administered intravenously for the full treatment period. At Week 24, participants randomized to E2814 placebo will receive placebo intravenously in a blinded fashion for the remainder of their treatment period. Asymptomatic Population (Cohort 2) At Week 0, participants randomized to E2814 placebo will receive placebo intravenously in a blinded fashion for the full treatment period. At Week 52, all participants will initiate open-label lecanemab administered intravenously for the remainder of their treatment period. |
| Name | Type | Description |
|---|---|---|
| Gantenerumab | DRUG | Subcutaneously every 4 weeks at escalating doses |
| Solanezumab | DRUG | Intravenous infusion every 4 weeks at escalating doses |
| Matching Placebo (Gantenerumab) | DRUG | Subcutaneous injection of placebo every 4 weeks |
| Matching Placebo (Solanezumab) | DRUG | Intravenous infusion of placebo every 4 weeks |
| E2814 | DRUG | Administered intravenously in a blinded fashion |
| Lecanemab | DRUG | Administered intravenously |
| Matching Placebo (E2814) | DRUG | Placebo administered intravenously in a blinded fashion. |
Inclusion Criteria: * Between 18-80 years of age * Individuals who know they have an Alzheimer's disease-causing mutation or are unaware of their genetic status and have dominantly inherited Alzheimer's disease (DIAD) mutation in their family. * Are within -15 to + 10 years of the predicted or actu...
Gantenerumab is an investigational antibody being studied for Alzheimer's disease, including familial early-onset Alzheimer's caused by genetic mutations. It is in Phase 2 clinical development and is not yet approved. The drug is being evaluated in trials enrolling adults aged 18 years and older.
Gantenerumab is a monoclonal antibody, indicated by its -mab suffix. It is designed to target and bind to amyloid beta proteins in the brain, which are implicated in Alzheimer's disease pathology. This mechanism aims to clear these proteins and potentially slow disease progression.
Gantenerumab is being developed by Eli Lilly and Company, a pharmaceutical company listed on the stock exchange under the ticker LLY. The company is conducting clinical trials to evaluate the drug's safety and efficacy in Alzheimer's disease.
Gantenerumab is currently in Phase 2 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities. The ongoing trials are designed to assess its potential as a disease-modifying treatment for Alzheimer's disease.
Gantenerumab is being studied in two Phase 2 trials. NCT01760005 is an active, not recruiting study with 490 participants, and NCT04623242 is a completed study with 194 participants. Both trials focus on Alzheimer's disease, including familial forms, and are placebo-controlled, double-blind, and randomized.
Gantenerumab is a distinct monoclonal antibody developed by Eli Lilly. It is not the same as other Alzheimer's treatments, as it specifically targets amyloid beta. Its development is focused on early-onset familial Alzheimer's disease, differentiating it from other investigational therapies.