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NCT05269394 · ClinicalTrials.gov registry record · Phase 2
Dominantly Inherited Alzheimer Network Trial: An Opportunity to Prevent Dementia. A Study of Potential Disease Modifying Treatments in Individuals With a Type of Early Onset Alzheimer's Disease Caused by a Genetic Mutation (DIAN-TU)
A Phase 2 study of Dementia and Alzheimers Disease, sponsored by Washington University School of Medicine.
- Active
- Registry status
- Phase 2
- Development phase
- 197
- Enrollment target
- 20
- Study locations
NCT05269394: Active Phase 2 study of Dementia and Alzheimers Disease, sponsored by Washington University School of Medicine.
NCT05269394 is a Phase 2 study of Dementia and Alzheimers Disease that is active but no longer recruiting, run by Washington University School of Medicine. The registered enrollment target is 197 participants, below the 7,722-participant average among 199 other Dementia trials with a reported enrollment target (97% lower). The trial reports 20 study locations across 16 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05269394, a Phase 2 study of Dementia and Alzheimers Disease, is active but no longer recruiting, sponsored by Washington University School of Medicine.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 197 participants
- Enrollment target
- 20
- Study locations
Study Summary
To assess the safety, tolerability, biomarker, cognitive, and clinical efficacy of investigational products in participants with an Alzheimer's disease-causing mutation by determining if treatment with the study drug improves disease-related biomarkers and slows the rate of progression of cognitive or clinical impairment.
Primary Outcome
To determine whether E2814 is superior to placebo, when each is concurrently administered with lecanemab, in the change from Week 24 to Week 104 (interim analysis) and Week 208 (final analysis) in tau spread as measured by tau PET in the symptomatic population (Cohort 1).
Conditions Studied
Interventions
- DRUG Lecanemab
- DRUG E2814
- DRUG Matching Placebo (E2814)
Study Locations (20)
Other
- Instituto de Investigaciones Neurologicas Raul Carrea, FLENI - Ciudad Autonoma de Buenos Aire
- Hospital das Clínicas da Faculdade de Medicina da USP - São Paulo
- CHU de Quebec - Hôpital de l' Enfant Jésus - Québec
- Grupo de Neurociencias Sede de la Universidad de Antioquia - Medellín
California
- University of California San Diego Medical Center - La Jolla
- USC Keck School of Medicine - Los Angeles
Alabama
- University of Alabama in Birmingham - Birmingham
Connecticut
- Yale University School of Medicine - New Haven
Georgia
- Emory University - Atlanta
Illinois
- Advocate Lutheran General Hospital - Park Ridge
Indiana
- Indiana University School of Medicine - Indianapolis
Missouri
- Washington University in St. Louis - St Louis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 197 participants |
| Start Date | 2021-12-22 |
| Est. Completion | 2028-07 |
| Phase | Phase 2 |
What the registry record for NCT05269394 still lists
NCT05269394 is an interventional study that assigns participants to a tested intervention. The registered 197 participants enrollment target is mid-sized for trials with a published cap, below the 7,722-participant average among 199 other Dementia trials with a reported enrollment target (97% lower).
The record links to 3 conditions, with Dementia appearing as the primary indexed condition, and to 3 interventions - of which Lecanemab is the first listed.
NCT05269394 names 20 study sites across 16 states, led by Other, California, Alabama.
Frequently Asked Questions
What is clinical trial NCT05269394 about?
NCT05269394 is a clinical study titled "Dominantly Inherited Alzheimer Network Trial: An Opportunity to Prevent Dementia. A Study of Potential Disease Modifying Treatments in Individuals With a Type of Early Onset Alzheimer's Disease Caused by a Genetic Mutation (DIAN-TU)". To assess the safety, tolerability, biomarker, cognitive, and clinical efficacy of investigational products in participants with an Alzheimer's disease-causing mutation by determining if treatment with the study drug improves disease-related biomarkers and slows the rate of progression of cognitive ...
What is the current status of trial NCT05269394?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 197 participants. The study started on 2021-12-22. Estimated completion is 2028-07.
What conditions does trial NCT05269394 study?
This clinical trial studies the following conditions: Dementia, Alzheimers Disease, Alzheimers Disease, Familial.
What interventions are being tested in trial NCT05269394?
The interventions under investigation include: Lecanemab (DRUG), E2814 (DRUG), Matching Placebo (E2814) (DRUG).
Who is sponsoring clinical trial NCT05269394?
This trial is sponsored by Washington University School of Medicine, which has 1,502 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05269394 being conducted?
This trial has 20 study locations across Alabama, California, Connecticut, Georgia, Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Dementia
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.
Where NCT05269394's enrollment target sits among peer trials
197 93rd of 199 higher than 107 of 199 other Dementia trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Dementia trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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