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Semagludtide · 1 trial · 1 indication
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...
Semaglutide is being studied as a potential treatment for early Alzheimer's disease. It is an investigational therapy in Phase 3 development for this neurology indication, and it has not been approved for Alzheimer's disease. The clinical program enrolled 1,840 participants aged 55 years and older with early Alzheimer's disease.
Semaglutide is a peptide in the -tide class. In the early Alzheimer's disease program it was evaluated as a placebo-controlled, double-blind, randomized treatment in biomarker-selected participants. The Phase 3 study was designed to assess its effects in people with early Alzheimer's disease compared with placebo.
Semaglutide is developed by Novo Nordisk A/S, which trades under the ticker NVO. Novo Nordisk sponsored the Phase 3 clinical program evaluating semaglutide in early Alzheimer's disease, including the EVOKE study.
Semaglutide is in Phase 3 development for early Alzheimer's disease. The program includes one completed Phase 3 trial, and no trials in this indication are currently active. Semaglutide is investigational for Alzheimer's disease and is not approved for this use.
Semaglutide was evaluated in the Phase 3 EVOKE study, registered as NCT04777396, titled A Research Study Investigating Semaglutide in People With Early Alzheimer's Disease. The trial enrolled 1,840 participants, was randomized, double-blind, and placebo-controlled, and has completed. It included sites across the United States, Europe, Asia, Latin America, and other regions.