LivingGLP1
Study S001717

A Randomised Double-blind Placebo-controlled Clinical Trial Investigating the Effect and Safety of Oral Semaglutide in Subjects With Early Alzheimer´s Disease (EVOKE)

Registration

Registration
NCT04777396
Acronym
EVOKE
Study type
INTERVENTIONAL
Allocation
RANDOMIZED
Phase
PHASE3
Masking
QUADRUPLE
Status
COMPLETED
Enrollment
1840
Start
2021-05-18
Primary completion
2025-09-16
Lead sponsor
Novo Nordisk A/S
Conditions
Early Alzheimer's Disease
Interventions
DRUG:Semagludtide; DRUG:Placebo (semaglutide)
Results posted
FALSE
Individual participant data sharing
YES
Secondary identifiers
OTHER:U1111-1259-2929; OTHER:2023-506919-18; NIH:2023

Registered primary outcomes

  • Change in the Clinical Dementia Rating - Sum of Boxes (CDR-SB) score [From baseline (week 0) to week 104]

Linked records (11)

Automatic links, confirmed or rejected during screening. A record citing this registration may be a secondary analysis, a commentary or a review that mentions the trial.
RecordTitleYearDesignIdentifiersLink basis
R0005459Baseline characteristics from evoke and evoke+: Two phase 3 randomized placebo-controlled trials of semaglutide in participants with early-stage symptomatic Alzheimer's disease.
Scheltens P, Alzheimer's & dementia (New York, N. Y.)
2026Randomized trialPMID 41522368DOIcites ClinicalTrials.gov:NCT04777396
R0010697Efficacy 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.
Cummings JL, Lancet (London, England)
2026Randomized trialPMID 41865758DOIcites ClinicalTrials.gov:NCT04777396; registry reference DERIVED:41865758
R0007201evoke and evoke+: design of two large-scale, double-blind, placebo-controlled, phase 3 studies evaluating efficacy, safety, and tolerability of semaglutide in early-stage symptomatic Alzheimer's disease.
Cummings JL, Alzheimer's research & therapy
2025Randomized trialPMID 39780249DOIcites ClinicalTrials.gov:NCT04777396; registry reference DERIVED:39780249
R0007283evoke and evoke+: design of two large-scale, double-blind, placebo-controlled, phase 3 studies evaluating efficacy, safety, and tolerability of semaglutide in early-stage symptomatic Alzheimer’s disease
Cummings JL, Research Square
2024Randomized trialDOIcites ClinicalTrials.gov:NCT04777396
R0017925Reasons for screening failure in the evoke and evoke+ trials of semaglutide for early AD
Sano M, Alzheimer's & dementia : the journal of the Alzheimer's Association
2024Randomized trialDOIcites ClinicalTrials.gov:NCT04777396
R0018118Investigating the effects of semaglutide in early Alzheimer’s disease using single‐cell transcriptomics and proteomics – rationale and design
Johannsen P, Alzheimer's & dementia : the journal of the Alzheimer's Association
2024ProtocolDOIcites ClinicalTrials.gov:NCT04777396
R0048823Baseline Characteristics from Evoke and Evoke+: Two Phase 3 Randomized Placebo-controlled Trials of Oral Semaglutide in Patients with Early Alzheimer’s Disease (P11-9.013)
Philip Scheltens, Neurology
2024Randomized trialPMID 39977949DOIcites ClinicalTrials.gov:NCT04777396
R0048854Preliminary baseline characteristics from evoke and evoke+: two phase 3 randomized placebo-controlled trials of oral semaglutide in patients with early Alzheimer’s disease
Philip Scheltens, Arquivos de Neuro-Psiquiatria
2024Randomized trialDOIcites ClinicalTrials.gov:NCT04777396
R0053377Regional differences in baseline demographic and clinical characteristics from the evoke and evoke+ trials of semaglutide for early Alzheimer’s disease
Wiesje M. van der Flier, Alzheimer s & Dementia
2024Randomized trialDOIcites ClinicalTrials.gov:NCT04777396
R0048974Investigating changes in fluid biomarkers in early Alzheimer’s disease: design of plasma biomarker analyses and a cerebrospinal fluid sub‐study in the evoke and evoke+ trials of semaglutide versus placebo
Jeffrey L. Cummings, Alzheimer s & Dementia
2022Randomized trialDOIcites ClinicalTrials.gov:NCT04777396
R0053617evoke and evoke+: design of two large‐scale, double‐blind, placebo‐controlled, phase 3 studies evaluating the neuroprotective effects of semaglutide in early Alzheimer’s disease
Alireza Atri, Alzheimer s & Dementia
2022Randomized trialDOIcites ClinicalTrials.gov:NCT04777396