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Clinical Trials in Ireland / NCT05269394
Active, not recruiting Phase 2/Phase 3

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 · tracked via the Priya Life Science Ireland tracker
Sponsor
Washington University School of Medicine
Phase
Phase 2/Phase 3
Started
2021-12-22
Last updated
2026-07-27

Condition(s) studied

Alzheimers DiseaseDementiaAlzheimers Disease, Familial

Investigational drug(s) / intervention(s)

E2814LecanemabMatching Placebo (E2814)

E2814: Administered intravenously in a blinded fashion

Lecanemab: Administered intravenously

Matching Placebo (E2814): Placebo administered intravenously in a blinded fashion.

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
80 Years
Healthy volunteers
No
Key Inclusion Criteria: * Between 18-80 years of age * Individuals who know they have an Alzheimer's disease-causing mutation. * Are within -10 to + 10 years of the predicted or actual age of cognitive symptom onset. * Cognitively normal or with mild cognitive impairment or mild dementia, Clinical Dementia Rating (CDR) of 0-1 (inclusive) * Fluency in DIAN-TU trial approved language and evidence of adequate premorbid intellectual functioning * Able to undergo Magnetic Resonance Imaging (MRI), Lumbar Puncture (LP), Positron Emission Tomography (PET), and complete all study related testing and evaluations. * For women of childbearing potential, if partner is not sterilized, participant must agree to use effective contraceptive measures (hormonal contraception, intra-uterine device, sexual abstinence, barrier method with spermicide). * Adequate visual and auditory abilities to perform all aspects of the cognitive and functional assessments. * Has a Study Partner who in the investigator's judgment is able to provide accurate information as to the subject's cognitive and functional abilities, who agrees to provide information at the study visits which require informant input for scale completion. Key Exclusion Criteria: * Significant neurologic disease (other than AD) or psychiatric disease that may currently or during the course of the study affect cognition or participant's ability to complete the study. * At high risk for suicide, e.g., significant suicidal ideation or attempt within last 12 months. Current stable mild depression or current use of antidepressant medications is not exclusionary. * History or presence of brain MRI scans indicative of any other significant abnormality * Substance or alcohol use disorder currently or within the past 1 year * Presence of pacemakers, aneurysm clips, artificial heart valves, ear implants, or foreign metal objects in the eyes, skin or body which would preclude MRI scan. * History or presence of clinically significant cardiovascular disease, hepatic/renal disorders, infectious disease or immune disorder, or metabolic/endocrine disorders * Anticoagulants except low dose (≤ 325 mg) aspirin. * Have been exposed to a monoclonal antibody targeting beta amyloid peptide within the past six months. * History of cancer within the last 5 years, except basal cell carcinoma, non-squamous skin carcinoma, prostate cancer or carcinoma in situ with no significant progression over the past 2 years. * Positive urine or serum pregnancy test or plans or desires to become pregnant during the course of the trial. * Subjects unable to complete all study related testing, including implanted metal that cannot be removed for MRI scanning, required anticoagulation and pregnancy.

Primary outcome measure(s)

Trial sites (36)

FacilityCityRegionStatus
University of Alabama in Birmingham Birmingham Alabama
University of California San Diego Medical Center La Jolla California
USC Keck School of Medicine Los Angeles California
Yale University School of Medicine New Haven Connecticut
Emory University Atlanta Georgia
Advocate Lutheran General Hospital Park Ridge Illinois
Indiana University School of Medicine Indianapolis Indiana
Washington University in St. Louis St Louis Missouri
University of Pittsburgh Pittsburgh Pennsylvania
Butler Hospital Providence Rhode Island
Kerwin Research Center, Dallas Texas
University of Washington Seattle Washington
Instituto de Investigaciones Neurologicas Raul Carrea, FLENI Ciudad Autonoma de Buenos Aire Argentina
Neuroscience Research Australia Randwick New South Wales
Alzheimer's Research Australia Melbourne Victoria
Hospital das Clínicas da Faculdade de Medicina da USP São Paulo Brazil
Sunnybrook Health Sciences Centre Toronto Ontario
McGill Center for Studies in Aging Verdun Quebec
CHU de Quebec - Hôpital de l' Enfant Jésus Québec Canada
Grupo de Neurociencias Sede de la Universidad de Antioquia Medellín Colombia
CHU de Toulouse - Hôpital Purpan Toulouse Haute Garonne
Hopital Roger Salengro - CHU Lille Lille Nord
Groupe Hospitalier Pitie-Salpetriere Paris Paris
Hopital Neurologique Pierre Wertheimer Bron Rhone
CHU de Rouen - Hôpital Charles Nicolle Rouen Seine Maritime
Universitaetsklinikum Tubingen Tübingen Baden-Wurttemberg
LMU-Campus Grosshadern Munich Bavaria
St Vincent's University Hospital Dublin Ireland
IRCCS Centro San Giovanni di Dio Fatebenefratelli Brescia Italy
Azienda Ospedaliera Universitaria Careggi Florence Italy
University of Tokyo Hospital Bunkyō City Tokyo-To
Instituto Nacional de Neurologia y Neurocirugia Manuel Velasco Suarez Mexico City Mexico City
Brain Research Center Amsterdam Netherlands
University of Puerto Rico, School of Medicine San Juan Puerto Rico
Hospital Clínic I Provincial de Barcelona Barcelona Spain
The National Hospital for Neurology and Neurosurgery London Greater London
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05269394 on ClinicalTrials.gov ↗ ← All trials in Ireland