Efficacy and safety of oral semaglutide 14 mg (flexible dose) in early-stage symptomatic Alzheimer's disease (evoke and evoke+): two phase 3, randomised, placebo-controlled trials - PubMed
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- #Alzheimer's disease
- #semaglutide
- #clinical trial
- The evoke and evoke+ trials investigated the efficacy and safety of oral semaglutide 14 mg in individuals with early-stage symptomatic Alzheimer's disease.
- Both trials were phase 3, randomized, double-blind, placebo-controlled studies conducted across 566 sites in 40 countries.
- Participants were aged 55-85 years with amyloid-confirmed Alzheimer's disease, mild cognitive impairment, or mild dementia.
- The primary endpoint was the change in Clinical Dementia Rating-Sum of Boxes (CDR-SB) score from baseline to week 104.
- Results showed no significant difference in CDR-SB score changes between semaglutide and placebo groups in both trials.
- Treatment-emergent adverse events were more common in the semaglutide group (91.2%) compared to placebo (84.8%).
- Five fatalities were reported, with one in the semaglutide group and four in the placebo group.
- The trials were discontinued due to negative clinical outcomes, concluding that oral semaglutide was not efficacious in slowing Alzheimer's disease progression.
- Safety and tolerability of semaglutide in early Alzheimer's disease were consistent with studies in other indications.