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ACTIVE NOT RECRUITING
NCT01760005
PHASE2/PHASE3

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

View on ClinicalTrials.gov

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

DRUG

Gantenerumab

Subcutaneously every 4 weeks at escalating doses

DRUG

Solanezumab

Intravenous infusion every 4 weeks at escalating doses

DRUG

Matching Placebo (Gantenerumab)

Subcutaneous injection of placebo every 4 weeks

DRUG

Matching Placebo (Solanezumab)

Intravenous infusion of placebo every 4 weeks

DRUG

Gantenerumab

Open-label administered Subcutaneously every 4 weeks at escalating doses

DRUG

E2814

Administered intravenously in a blinded fashion

DRUG

Lecanemab

Administered intravenously

DRUG

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