Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT04623242 | Dominantly Inherited Alzheimer Network Trial: An Opportunity to Prevent Dementia. A Study of Potential Disease Modifying Treatments in Individuals at Risk for or With a Type of Early Onset Alzheimer's Disease Caused by a Genetic Mutation. | PHASE2 | COMPLETED | 194 | — | — | Dec 1, 2012 | Mar 6, 2020 | Sep 22, 2022 | 25 | United States, Australia +6 |
| NCT01760005 | Dominantly Inherited Alzheimer Network Trial: An Opportunity to Prevent Dementia. A Study of Potential Disease Modifying Treatments in Individuals at Risk for or With a Type of Early Onset Alzheimer's Disease Caused by a Genetic Mutation. Master Protocol DIAN-TU-001 | PHASE2 | ACTIVE NOT_RECRUITING | 490 | — | — | Dec 1, 2012 | Jul 1, 2028 | Feb 13, 2026 | 38 | United States, Argentina +13 |
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...