A Research Study Investigating Semaglutide in People With Early Alzheimer's Disease (EVOKE Plus)

Conditions

• Early Alzheimer´s Disease

Eligibility Criteria

Sex

ALL

Age

55 Years - 85 Years

Healthy Volunteers

Not accepted

Interventions

• Semaglutide — 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

Study Details

This study is done to find out whether the medicine, semaglutide, has a positive effect on early Alzheimer's disease. Participants will either get semaglutide or placebo (a "dummy" medicine which does not contain any study medicine) - which treatment participants get is decided by an equal chance. The study will last for up to 173 weeks (about 3 years and 4 months). Participants will have 17 clinic visits and 1 phone call with the study doctor. The study includes various tests and scans. At 10 of the clinic visits participants will have blood samples taken. Participants must have a study partner, who is willing to take part in the study. Women cannot take part if pregnant, breastfeeding or plan to become pregnant during the study period. A cerebrospinal fluid (CSF) sub-study will be performed as a part of the study. The sub-study will be performed on a selection of sites based on their experience with CSF sampling and willingness to participate in this sub-study. The endpoints related to this sub-study are exploratory only.

Key Dates

Start date

May 18, 2021

Status verified

Mar 2026

Primary completion

Sep 15, 2025

Completion

Jan 30, 2026

Study Design

Enrollment

1,840 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Oral semaglutide
  Participants are given oral semaglutide once daily
• Placebo Comparator: Placebo (semaglutide)
  Participants are given oral placebo once daily

Primary Outcome Measure

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

Locations (107)

Related coverage on Hipa.ai

• Semaglutide EVOKE Plus Trial for Early Alzheimer's Disease Reaches Primary…
  Semaglutide · Sep 15, 2025 · ClinicalTrials.gov

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