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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT04777396 | A Research Study Investigating Semaglutide in People With Early Alzheimer's Disease (EVOKE) | PHASE3 | COMPLETED | 1,840 | — | — | May 18, 2021 | Jan 30, 2026 | Apr 9, 2026 | 444 | United States, Argentina +35 |
Score on scale (0 to 18) Measures the impact of cognitive decline on daily function using the following six domains commonly affected in Alzheimer's disease: * Cognitive domains: memory, orientation, and judgement and problem solving * Function domains: community affairs, home and hobbies, and personal care Based on clinical information obtained from the subject and informant, an individual box score ranging from 0 to 3 is determined that represents "none" to "severe" impairment for each of the six domains. The CDR-Sum of Boxes (CDR-SB) score will be derived by adding the individual scores of the six domains at a given time point. The total CDR-SB score ranges from 0 to 18 with higher scores representing greater impairment.
| Arm | Type | Description |
|---|---|---|
| Oral Semaglutide | EXPERIMENTAL | Participants are given oral semaglutide once daily |
| Placebo (semagludtide) | PLACEBO_COMPARATOR | Participants are given oral placebo once daily |
| Name | Type | Description |
|---|---|---|
| Semagludtide | DRUG | Oral semaglutide once-daily, dose gradually increased to 14 mg. The study will last for up to 173 weeks |
| Placebo (semaglutide) | DRUG | Oral placebo (semaglutide) once-daily, The study will last for up to 173 weeks |
Inclusion Criteria: * Male or female, aged 55-85 years (both inclusive) at the time of signing informed consent. * MCI (mild cognitive impairment) or mild dementia of the Alzheimer's type according to the NIA-AA (National Institute of Aging-Alzheimer's Association) 2018 criteria. * CDR (Clinical De...