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Dominantly Inherited Alzheimer Network Trial: An Opportunity to Prevent Dementia. A Study of Potential Disease Modifying Treatments in Individuals at Risk for or With a Type of Early Onset Alzheimer's Disease Caused by a Genetic Mutation. Master Protocol DIAN-TU-001
Sponsor: Washington University School of Medicine
Summary
The purpose of this study is 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 slows the rate of progression of cognitive/clinical impairment or improves disease-related biomarkers.
Official title: A Phase II/III Multicenter Randomized, Double-Blind, Placebo-Controlled Platform Trial of Potential Disease Modifying Therapies Utilizing Biomarker, Cognitive, and Clinical Endpoints in Dominantly Inherited Alzheimer's Disease
Key Details
Gender
All
Age Range
18 Years - 80 Years
Study Type
INTERVENTIONAL
Enrollment
490
Start Date
2012-12
Completion Date
2028-07
Last Updated
2026-02-13
Healthy Volunteers
Yes
Interventions
Gantenerumab
Subcutaneously every 4 weeks at escalating doses
Solanezumab
Intravenous infusion every 4 weeks at escalating doses
Matching Placebo (Gantenerumab)
Subcutaneous injection of placebo every 4 weeks
Matching Placebo (Solanezumab)
Intravenous infusion of placebo every 4 weeks
Gantenerumab
Open-label administered Subcutaneously every 4 weeks at escalating doses
E2814
Administered intravenously in a blinded fashion
Lecanemab
Administered intravenously
Matching Placebo (E2814)
Placebo administered intravenously in a blinded fashion.
Locations (38)
University of Alabama in Birmingham
Birmingham, Alabama, United States
University of California San Diego Medical Center
La Jolla, California, United States
USC Keck School of Medicine
Los Angeles, California, United States
Yale University School of Medicine
New Haven, Connecticut, United States
Emory University
Atlanta, Georgia, United States
Advocate Lutheran General Hospital
Park Ridge, Illinois, United States
Indiana University School of Medicine
Indianapolis, Indiana, United States
Washington University in St. Louis
St Louis, Missouri, United States
University of Pittsburgh
Pittsburgh, Pennsylvania, United States
Butler Hospital
Providence, Rhode Island, United States
Kerwin Medical Center
Dallas, Texas, United States
University of Washington
Seattle, Washington, United States
Instituto de Investigaciones Neurologicas Raul Carrea, FLENI
Ciudad Autonoma de Buenos Aire, Argentina
Neuroscience Research Australia
Randwick, New South Wales, Australia
Alzheimer's Research Australia
Melbourne, Victoria, Australia
The McCuster Foundation of Alzheimer's Disease Research
Nedlands, Western Australia, Australia
Hospital das Clínicas da Faculdade de Medicina da USP
São Paulo, Brazil
UBC Hospital
Vancouver, British Columbia, Canada
Sunnybrook Health Sciences Centre
Toronto, Ontario, Canada
McGill Center for Studies in Aging
Verdun, Quebec, Canada
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, France
Hopital Roger Salengro - CHU Lille
Lille, Nord, France
Groupe Hospitalier Pitie-Salpetriere
Paris, Paris, France
Hopital Neurologique Pierre Wertheimer
Bron, Rhone, France
CHU de Rouen - Hôpital Charles Nicolle
Rouen, Seine Maritime, France
Universitaetsklinikum Tubingen
Tübingen, Baden-Wurttemberg, Germany
LMU-Campus Grosshadern
Munich, Bavaria, Germany
St Vincent's University Hospital
Dublin, Ireland
IRCCS Centro San Giovanni di Dio Fatebenefratelli
Brescia, Italy
Azienda Ospedaliera Universitaria Careggi
Florence, Italy
Niigata University Medical & Dental Hospital
Niigata, Niigata, Japan
University of Tokyo Hospital
Bunkyō City, Tokyo-To, Japan
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, United Kingdom