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NCT04777409 · ClinicalTrials.gov registry record · Phase 3

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

A Phase 3 study of Early Alzheimer's Disease, sponsored by Novo Nordisk A/S.

Active
Registry status
Phase 3
Development phase
1,840
Enrollment target
20
Study locations

NCT04777409 is a Phase 3 study of Early Alzheimer's Disease that is active but no longer recruiting, run by Novo Nordisk A/S. The registered enrollment target is 1,840 participants, above the 839-participant average among 7 other Early Alzheimer's Disease trials with a reported enrollment target (119% higher). The trial reports 20 study locations across 4 states.

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The verdict

NCT04777409, a Phase 3 study of Early Alzheimer's Disease, is active but no longer recruiting, sponsored by Novo Nordisk A/S.

ACTIVE NOT RECRUITING
Registry status
Phase 3
Development phase
1,840 participants
Enrollment target
20
Study locations

Study Summary

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.

Conditions Studied

Early Alzheimer's Disease

Interventions

  • DRUG Semaglutide
  • DRUG Placebo (semaglutide)

Study Locations (20)

California

  • Advanced Research Center, Inc. - Anaheim
  • Torrance Clin Res Inst, Inc. - Lomita
  • ASCLEPES Research Centers, - Long Beach
  • Cedars-Sinai Medical Center - Los Angeles
  • UCLA_Los Angeles - Los Angeles
  • Wr-Pri, Llc - Newport Beach
  • Well Care Medical Center - Panorama City
  • Cedars-Sinai Medical Center - Pasadena
  • Sharp Neurocog Res Ctr - San Diego
  • Syrentis Clinical Research - Santa Ana
  • Calfornia Neurosc Resrch Med - Sherman Oaks
  • Southern California Research LLC - Simi Valley

Arizona

  • Banner Alzheimer's Institute - Phoenix
  • Imaging Endpoints - Scottsdale
  • Banner Sun Health Research Institute - Sun City
  • Tucson Neuroscience Research - Tucson

Colorado

  • Mountain Neurological Research Center, Inc. - Basalt
  • Denver Neurological Research - Denver
  • Mile High Research Center - Denver

Connecticut

  • Nuvance Health, Associtd Neuro - Danbury

Trial Details

FieldValue
Enrollment Target 1,840 participants
Start Date 2021-05-18
Est. Completion 2026-01-23
Phase Phase 3

Sponsor

Novo Nordisk A/S

431 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT04777409

The ClinicalTrials.gov registry entry for NCT04777409 describes a study currently listed as active not recruiting, categorized as Phase 3. The registered enrollment target is 1,840 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 839-participant average among 7 other Early Alzheimer's Disease trials with a reported enrollment target (119% higher). The listed sponsor is Novo Nordisk A/S, which has 431 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Early Alzheimer's Disease appearing as the primary indexed condition, and to 2 interventions - of which Semaglutide is the first listed.

NCT04777409 reports 20 study locations spanning 4 distinct geographic areas - top geographies include California, Arizona, Colorado.

Frequently Asked Questions

What is clinical trial NCT04777409 about?

NCT04777409 is a clinical study titled "A Research Study Investigating Semaglutide in People With Early Alzheimer's Disease (EVOKE Plus)". 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. ...

What is the current status of trial NCT04777409?

This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 1,840 participants. The study started on 2021-05-18. Estimated completion is 2026-01-23.

What conditions does trial NCT04777409 study?

This clinical trial studies the following conditions: Early Alzheimer's Disease.

What interventions are being tested in trial NCT04777409?

The interventions under investigation include: Semaglutide (DRUG), Placebo (semaglutide) (DRUG).

Who is sponsoring clinical trial NCT04777409?

This trial is sponsored by Novo Nordisk A/S, which has 431 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT04777409 being conducted?

This trial has 20 study locations across Arizona, California, Colorado, Connecticut. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.