RecruitingPhase 2Phase 3NCT05552157

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

A Phase II/III Multicenter Randomized, Double-Blind, Placebo-Controlled, Two-Stage Adaptive Design, Platform Trial of Investigational Treatments for Primary Prevention of Disease Progression in Dominantly Inherited Alzheimer's Disease

Sponsor

Washington University School of Medicine

Enrollment

280 participants

Start Date

Nov 22, 2024

Study Type

INTERVENTIONAL

Conditions

Dementia Alzheimers Disease Alzheimers Disease, Familial

Summary

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial is studying potential treatments for a rare, inherited form of early-onset Alzheimer's disease caused by a specific genetic mutation. It targets people who either carry the gene mutation (at risk) or have early signs of the disease. **You may be eligible if...** - You are at least 18 years old - You carry a genetic mutation known to cause early-onset familial Alzheimer's disease, or have been diagnosed with early-stage disease caused by such a mutation - You have a study partner (family member or close friend) who can assist with assessments - If you can become pregnant, you must agree to use effective contraception and not breastfeed during the study **You may NOT be eligible if...** - You have other significant brain or neurological conditions - You have serious heart, liver, or kidney disease - You are pregnant or planning to become pregnant during the study - You are unwilling or unable to comply with study requirements Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGRemternetug (SC)

Administered subcutaneously every 12 weeks

DRUGMatching Placebo (Remternetug)

Administered as subcutaneous injection of placebo every 12 weeks

Locations(35)

University of Alabama in Birmingham

Birmingham, Alabama, United States

University of California San Diego Medical Center

La Jolla, 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

New York University Medical Center

New York, New York, United States

University of Pittsburgh

Pittsburgh, Pennsylvania, United States

Butler Hospital

Providence, Rhode Island, United States

Kerwin Research and Memory 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

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

IRCCS Centro San Giovanni di Dio Fatebenefratelli

Brescia, Italy

Azienda Ospedaliera Universitaria Careggi

Florence, Italy

Instituto Nacional de Neurologia y Neurocirugia Manuel Velasco Suarez

Mexico City, Mexico City, Mexico

Brain Research Center

Amsterdam, Netherlands

New Zealand Brain Research Institute

Christchurch, New Zealand

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

View Full Details on ClinicalTrials.gov

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