RecruitingPhase 2Phase 3NCT06647498

A Study of a Potential Disease Modifying Treatment 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 of this research study is to test the study drug, referred to as remternetug, to determine its effectiveness for the study treatment of asymptomatic (at risk) Alzheimer disease in individuals with AD-causing mutations. This study will also investigate the effects of remternetug on biomarkers (measures of the disease including brain scans, blood and spinal fluid tests), examine safety data to identify any potential benefits or risks, and examine how well participants can tolerate remternetug. Stage 1 will determine if treatment with the study drug prevents or reverses amyloid beta (Aβ) accumulation compared with placebo in participants with dominantly inherited Alzheimer's disease (DIAD). Stage 2 will evaluate the effect of early anti-amyloid treatment on downstream biomarkers of AD in treated participants compared to external control groups.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a potential disease-modifying treatment for a rare inherited form of early-onset Alzheimer's disease (called Dominantly Inherited Alzheimer's Disease or DIAD), which is caused by specific gene mutations and typically causes memory problems earlier in life than the common form of Alzheimer's. **You may be eligible if...** - You are 18 years or older - You carry a known mutation in the APP, PSEN1, or PSEN2 gene associated with DIAD, OR you do not yet know your status but have a strong family history of this mutation - You are estimated to be 11–25 years before your predicted age of symptom onset - Your memory and thinking are currently completely normal (CDR score of 0) - You are fluent in a language for which the study assessments have been validated **You may NOT be eligible if...** - You already have cognitive symptoms or memory problems - You test negative for the family mutation during the study (you would be withdrawn) - You are pregnant or breastfeeding, or unwilling to use contraception during the study 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

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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