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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)

NCT05269394 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 197

Last updated 2026-02-13

No results posted yet for this 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.

Conditions

  • Dementia
  • Alzheimers Disease
  • Alzheimers Disease, Familial

Interventions

DRUG

E2814

Administered intravenously in a blinded fashion

DRUG

Lecanemab

Administered intravenously

DRUG

Matching Placebo (E2814)

Placebo administered intravenously in a blinded fashion.

Sponsors & Collaborators

  • Alzheimer's Association

    collaborator OTHER

  • National Institute on Aging (NIA)

    collaborator NIH

  • Accelerating Medicines Partnership (AMP)

    collaborator OTHER

  • Eisai Inc.

    collaborator INDUSTRY

  • Washington University School of Medicine

    lead OTHER

Principal Investigators

  • Randall J Bateman, MD · Washington University School of Medicine

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-12-22
Primary Completion
2028-04-30
Completion
2028-07-31
FDA Drug
Yes

Countries

  • United States
  • Argentina
  • Australia
  • Brazil
  • Canada
  • Colombia
  • France
  • Germany
  • Ireland
  • Italy
  • Japan
  • Mexico
  • Netherlands
  • Puerto Rico
  • Spain
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05269394 on ClinicalTrials.gov