Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT04777396 · ClinicalTrials.gov registry record · Phase 3
A Research Study Investigating Semaglutide in People With Early Alzheimer's Disease (EVOKE)
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
NCT04777396: Active Phase 3 study of Early Alzheimer's Disease, sponsored by Novo Nordisk A/S.
NCT04777396 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 3 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04777396, 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.
Primary Outcome
Score on scale (0 to 18) Measures the impact of cognitive decline on daily function using the following six domains commonly affected in Alzheimer's disease: * Cognitive domains: memory, orientation, and judgement and problem solving * Function domains: community affairs, home and hobbies, and personal care Based on clinical information obtained from the subject and informant, an individual box score ranging from 0 to 3 is determined that represents "none" to "severe" impairment for each of th
Conditions Studied
Interventions
- DRUG Placebo (semaglutide)
- DRUG Semagludtide
Study Locations (20)
California
- Advanced Research Center, Inc. - Anaheim
- Fullerton Neurology and Headache Center - Fullerton
- Pacific Research Network - Lemon Grove
- 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
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,840 participants |
| Start Date | 2021-05-18 |
| Est. Completion | 2026-01-23 |
| Phase | Phase 3 |
What the registry record for NCT04777396 still lists
NCT04777396 is an interventional study that assigns participants to a tested intervention. Its 1,840 participants enrollment target places it among the larger protocols in the corpus, above the 839-participant average among 7 other Early Alzheimer's Disease trials with a reported enrollment target (119% higher).
The record links to 1 condition, with Early Alzheimer's Disease appearing as the primary indexed condition, and to 2 interventions - of which Placebo (semaglutide) is the first listed.
NCT04777396 names 20 study sites across 3 states, led by California, Arizona, Colorado.
Frequently Asked Questions
What is clinical trial NCT04777396 about?
NCT04777396 is a clinical study titled "A Research Study Investigating Semaglutide in People With Early Alzheimer's Disease (EVOKE)". 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 NCT04777396?
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 NCT04777396 study?
This clinical trial studies the following conditions: Early Alzheimer's Disease.
What interventions are being tested in trial NCT04777396?
The interventions under investigation include: Placebo (semaglutide) (DRUG), Semagludtide (DRUG).
Who is sponsoring clinical trial NCT04777396?
This trial is sponsored by Novo Nordisk A/S, which has 431 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04777396 being conducted?
This trial has 20 study locations across Arizona, California, Colorado. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Early Alzheimer's Disease
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
-
A Double-blind Dual Study Assessing Safety and Efficacy of Buntanetap in Participants With Early AD
RECRUITING · Phase 3
-
A Study to Confirm Safety and Efficacy of Lecanemab in Participants With Early Alzheimer's Disease
ACTIVE NOT RECRUITING · Phase 3
-
Long-term Extension of Phase 3 Study of ALZ- 801 in APOE4/4 Early AD Subjects
ACTIVE NOT RECRUITING · Phase 3
-
A Research Study Investigating Semaglutide in People With Early Alzheimer's Disease (EVOKE Plus)
ACTIVE NOT RECRUITING · Phase 3
-
An Efficacy and Safety Study of ALZ-801 in APOE4/4 Early AD Subjects
COMPLETED · Phase 3
-
A Clinical Study of MK-2214 in People With Early Alzheimer's Disease (MK-2214-004)
RECRUITING · Phase 2
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT06740630 · 1,840 participants · Phase 3
A Study on the Immune Response and Safety of an Investigational Chickenpox Vaccine When Given to Healthy Children 12 to 15 Months of Age
- NCT07104240 · 1,836 participants · NA
A Vaccine Promotion Package (TweenVax) to Improve Adolescent HPV Vaccination, TweenVax Trial
- NCT06465810 · 1,850 participants
Non-interventional Study of Patients With Transthyretin (ATTR) Amyloidosis
- NCT06580080 · 1,850 participants · NA
Evaluation of Are You Ready?
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI