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A randomised double-blind placebo-controlled clinical trial investigating the effect and safety of oral semaglutide in subjects with early Alzheimer´s disease (EVOKE plus)

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2023-506918-45-00
Acronym
NN6535-4725
Enrollment
798
Registered
2024-02-16
Start date
2021-05-17
Completion date
Unknown
Last updated
2025-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Mild cognitive impairment (MCI) or mild dementia, both of the Alzheimer’s type

Brief summary

Change in the Clinical Dementia Rating – Sum of Boxes (CDR-SB) Score. From baseline (week 0) to week 104. Score on scale (0 to 18).

Detailed description

Change in the 24-item Alzheimer’s Disease Cooperative Study Activities of Daily Living Scale for MCI (ADCS-ADL-MCI) score. From baseline (week 0) to week 104. Score on scale (0 to 53)., Time to progression to CDR global score ≥1.0 among patients with CDR global score = 0.5 at baseline. From baseline (week 0) up to week 156.

Interventions

DRUGPlacebo (semaglutide) tablets

Sponsors

Novo Nordisk A/S
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
Change in the Clinical Dementia Rating – Sum of Boxes (CDR-SB) Score. From baseline (week 0) to week 104. Score on scale (0 to 18).

Secondary

MeasureTime frame
Change in the 24-item Alzheimer’s Disease Cooperative Study Activities of Daily Living Scale for MCI (ADCS-ADL-MCI) score. From baseline (week 0) to week 104. Score on scale (0 to 53)., Time to progression to CDR global score ≥1.0 among patients with CDR global score = 0.5 at baseline. From baseline (week 0) up to week 156.

Countries

Austria, Belgium, Bulgaria, Croatia, Czechia, Denmark, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Netherlands, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026