Clinical trialNCT05552157RecruitingPhase 2/PHASE3Interventional

A Study of Potential Disease Modifying Treatments in Individuals at Risk for or With a Type of Early Onset AD Caused by a Genetic Mutation

SponsorWashington University School of MedicineEnrollment280Alzheimers DiseaseAlzheimers Disease, FamilialDementia

View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

The purpose is to evaluate the biomarker effect, safety, and tolerability of investigational study drugs in participants who are known to have an Alzheimer's disease (AD)-causing mutation. Stage 1 will determine if treatment with the study drug prevents or slows the rate of amyloid beta (Aβ) pathological disease accumulation demonstrated by Aβ positron emission tomography (PET) imaging. Stage 2 will evaluate the effect of early Aβ plaque reduction/prevention on disease progression by assessing downstream non-Aβ biomarkers of AD (e.g., CSF total tau, p-tau, NfL) compared to an external control group from the DIAN-OBS natural history study and the DIAN-TU-001 placebo-treated participants.

clinicaltrials.gov ↗

Investigators

The overall officials registered on this study. Names that resolve to a findmyKOL profile link to it; the rest are shown as registered.

Eric M McDade, DO
Washington University School of Medicine
Study DirectorKOL profile →
clinicaltrials.gov ↗

A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

37 registered facilities, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

Argentina

Instituto de Investigaciones Neurologicas Raul Carrea, Fleni
Ciudad Autonoma de Buenos Aire, Argentina
Ricardo Allegri
Recruiting

Australia

Neuroscience Research Australia
Randwick, New South Wales, Australia
Emma Devenney
Recruiting
Alzheimer'S Research Australia
Melbourne, Victoria, Australia
Colin Masters
Recruiting

Canada

Ubc Hospital
Vancouver, British Columbia, Canada
Robin Hsiung
Recruiting
Sunnybrook Health Sciences Centre
Toronto, Ontario, Canada
Mario Masellis
Recruiting
Mcgill Center for Studies in Aging
Verdun, Quebec, Canada
Paola Vitali
Recruiting
Chu de Quebec - Hôpital de L' Enfant Jésus
Québec, Canada
Robert LaForce
Recruiting

Colombia

Grupo de Neurociencias Sede de la Universidad de Antioquia
Medellín, Colombia
David Fernando Aguillon Nino, M.D.
Recruiting

France

Chu de Toulouse - Hôpital Purpan
Toulouse, Haute Garonne, France
Jérémie Pariente
Not, yet, recruiting
Hopital Roger Salengro - Chu Lille
Lille, Nord, France
Adeline Rollin-Sillaire
Not, yet, recruiting
Groupe Hospitalier Pitie-Salpetriere
Paris, Paris, France
Nicolas Villian
Not, yet, recruiting
Hopital Neurologique Pierre Wertheimer
Bron, Rhone, France
Maité Formaglio
Not, yet, recruiting
Chu de Rouen - Hôpital Charles Nicolle
Rouen, Seine Maritime, France
David Wallon
Not, yet, recruiting

Germany

Universitaetsklinikum Tubingen
Tübingen, Baden-Wurttemberg, Germany
Cristoph Laske, M.D.
Recruiting
Lmu-Campus Grosshadern
Munich, Bavaria, Germany
Johannes Levin, M.D,
Not, yet, recruiting

Italy

Irccs Centro San Giovanni Di Dio Fatebenefratelli
Brescia, Italy
Barbara Borroni
Not, yet, recruiting
Azienda Ospedaliera Universitaria Careggi
Florence, Italy
Valentina Bessi, M.D.
Not, yet, recruiting

Mexico

Instituto Nacional de Neurologia Y Neurocirugia Manuel Velasco Suarez
Mexico City, Mexico City, Mexico
Ana Luisa Sosa Ortiz, M.D.
Not, yet, recruiting

Netherlands

Brain Research Center
Amsterdam, Netherlands
Jort Vijverberg, MD
Not, yet, recruiting

New Zealand

New Zealand Brain Research Institute
Christchurch, New Zealand
Campbell Le Heron, M.D.
Not, yet, recruiting

Puerto Rico

University of Puerto Rico, School of Medicine
San Juan, Puerto Rico
Ivonne Jimenez-Velazquez
Recruiting

South Korea

Asan Medical Center
Seoul, South Korea
Jae Sung Lim
Not, yet, recruiting

Spain

Hospital Clínic I Provincial de Barcelona
Barcelona, Spain
Raquel Sanchez Valle
Recruiting

United Kingdom

the National Hospital for Neurology and Neurosurgery
London, Greater London, United Kingdom
Catherine Mummery
Recruiting

United States

University of Alabama in Birmingham
Birmingham, Alabama, United States
Erik Roberson
Recruiting
University of California San Diego Medical Center
La Jolla, California, United States
Doug Galasko
Recruiting
University of Southern Califonria
Los Angeles, California, United States
John Ringman
Not, yet, recruiting
Yale University School of Medicine
New Haven, Connecticut, United States
Christopher Van Dyck
Recruiting
Emory University
Atlanta, Georgia, United States
James Lah
Recruiting
Advocate Lutheran General Hospital
Park Ridge, Illinois, United States
Darren Gitelman
Recruiting
Indiana University School of Medicine
Indianapolis, Indiana, United States
Jared Brosch
Recruiting
Washington University in St. Louis
St Louis, Missouri, United States
Barbara Snider
Recruiting
New York University Medical Center
New York, New York, United States
Thomas Wisniewski
Recruiting
University of Pittsburgh
Pittsburgh, Pennsylvania, United States
Sarah Berman
Recruiting
Butler Hospital
Providence, Rhode Island, United States
Edward Denmead Huey
Recruiting
Kerwin Research and Memory Center
Dallas, Texas, United States
Alka Khera
Recruiting
University of Washington
Seattle, Washington, United States
Suman Jayadev
Recruiting

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

The drug and biological interventions registered on this study, normalized to their RxNorm ingredient where possible.

Matching PlaceboRemternetug

Linked drugs open the directory filtered to KOLs working with them.clinicaltrials.gov ↗

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start: 22 Nov 2024
Primary completion: 30 Mar 2034
Completion: 30 Aug 2034
Last update posted: 27 Jul 2026
Registered enrollment: 280
Registry id: NCT05552157

clinicaltrials.gov ↗

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 24 Aug 2026. Registry facts are shown as registered by the study sponsor; findmyKOL does not interpret them.