Actively Recruiting
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
Led by Washington University School of Medicine · Updated on 2026-02-13
280
Participants Needed
35
Research Sites
505 weeks
Total Duration
On this page
Sponsors
W
Washington University School of Medicine
Lead Sponsor
A
Alzheimer's Association
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Provide written informed consent signed by the participant and study partner or legally authorized representative
- Be at least 18 years old
- For people who can become pregnant: have a negative pregnancy test at screening, agree to avoid pregnancy and breastfeeding during the study, and agree to use effective contraception if partner is not sterilized
- Carry a mutation in APP, PSEN1, or PSEN2 gene linked to dominantly inherited Alzheimer's disease or have a family history of such mutation
- Be 11 to 25 years before predicted age of cognitive symptom onset based on mutation or family history
- Have normal cognitive status (CDR-SB 0)
- Be fluent in DIAN-TU approved languages and have adequate intellectual functioning
- Have adequate vision and hearing to complete assessments
- Be on stable medication doses for non-excluded conditions for at least 30 days before baseline
- Have a study partner able to provide information on cognitive and functional abilities and who signs consent
- Agree not to donate blood during the study and for 5 half-lives after last dose
- Be expected to comply with and complete all study procedures
- Be willing and able to complete all study-related testing and evaluations
You will not qualify if you...
- Have significant neurologic or psychiatric disease affecting cognition or study participation
- Be at high risk for suicide or have recent major depression
- Have history of stroke or significant stroke risk factors affecting cognition or study participation
- Currently have alcohol or substance use disorder
- Have brain MRI showing significant abnormalities or conditions interfering with MRI
- Have implanted medical devices preventing MRI
- Have cardiovascular, hepatic, or renal conditions interfering with study participation
- Have history of HIV, recent Hepatitis B or untreated Hepatitis C, or CNS spirochete infections
- Have history of severe drug allergies or hypersensitivity to study drugs or imaging agents
- Have recently used immunosuppressive medications or chemotherapy
- Have significant thyroid or vitamin B12 abnormalities
- Have unstable or poorly controlled diabetes
- Have morbid obesity with significant comorbidities
- Use anticoagulants (except low-dose aspirin)
- Have recent exposure to monoclonal antibodies targeting amyloid beta or investigational treatments
- Lack sufficient venous access or have abnormal lab results affecting participation
- Have history of high-risk cancer
- Have medical conditions likely to bias assessments or pose special risk
- Recently participated in another clinical study without approval
- Carry the "Dutch" APP E693Q mutation
- Unable to complete baseline procedures with required cognitive and clinical scores
- Have MRI showing ARIA-E, multiple microhemorrhages, or severe white matter disease
- Have recent exposure to other investigational amyloid lowering agents
- Are investigator site personnel or their immediate family, or employees of involved organizations with required exclusion
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 35 locations
1
University of Alabama in Birmingham
Birmingham, Alabama, United States, 35294
Actively Recruiting
2
University of California San Diego Medical Center
La Jolla, California, United States, 92037
Actively Recruiting
3
Yale University School of Medicine
New Haven, Connecticut, United States, 06510
Actively Recruiting
4
Emory University
Atlanta, Georgia, United States, 30329
Actively Recruiting
5
Advocate Lutheran General Hospital
Park Ridge, Illinois, United States, 60068
Actively Recruiting
6
Indiana University School of Medicine
Indianapolis, Indiana, United States, 46202
Actively Recruiting
7
Washington University in St. Louis
St Louis, Missouri, United States, 63110
Actively Recruiting
8
New York University Medical Center
New York, New York, United States, 10016
Actively Recruiting
9
University of Pittsburgh
Pittsburgh, Pennsylvania, United States, 15213
Actively Recruiting
10
Butler Hospital
Providence, Rhode Island, United States, 02096
Actively Recruiting
11
Kerwin Research and Memory Center
Dallas, Texas, United States, 75231
Actively Recruiting
12
University of Washington
Seattle, Washington, United States, 98195
Actively Recruiting
13
Instituto de Investigaciones Neurologicas Raul Carrea, FLENI
Ciudad Autonoma de Buenos Aire, Argentina, C1428AQK
Actively Recruiting
14
Neuroscience Research Australia
Randwick, New South Wales, Australia, 2031
Actively Recruiting
15
Alzheimer's Research Australia
Melbourne, Victoria, Australia, 3010
Not Yet Recruiting
16
UBC Hospital
Vancouver, British Columbia, Canada, V6T 2B5
Actively Recruiting
17
Sunnybrook Health Sciences Centre
Toronto, Ontario, Canada, M4N 3M5
Actively Recruiting
18
McGill Center for Studies in Aging
Verdun, Quebec, Canada, H4H 1R3
Not Yet Recruiting
19
CHU de Quebec - Hôpital de l' Enfant Jésus
Québec, Canada, G1J 1Z4
Actively Recruiting
20
Grupo de Neurociencias Sede de la Universidad de Antioquia
Medellín, Colombia
Actively Recruiting
21
CHU de Toulouse - Hôpital Purpan
Toulouse, Haute Garonne, France, 31059
Not Yet Recruiting
22
Hopital Roger Salengro - CHU Lille
Lille, Nord, France, 59037
Not Yet Recruiting
23
Groupe Hospitalier Pitie-Salpetriere
Paris, Paris, France, 69677
Not Yet Recruiting
24
Hopital Neurologique Pierre Wertheimer
Bron, Rhone, France, 69677
Not Yet Recruiting
25
CHU de Rouen - Hôpital Charles Nicolle
Rouen, Seine Maritime, France, 76031
Not Yet Recruiting
26
Universitaetsklinikum Tubingen
Tübingen, Baden-Wurttemberg, Germany, 72076
Not Yet Recruiting
27
LMU-Campus Grosshadern
Munich, Bavaria, Germany, 81377
Not Yet Recruiting
28
IRCCS Centro San Giovanni di Dio Fatebenefratelli
Brescia, Italy, 25125
Not Yet Recruiting
29
Azienda Ospedaliera Universitaria Careggi
Florence, Italy, 50134
Not Yet Recruiting
30
Instituto Nacional de Neurologia y Neurocirugia Manuel Velasco Suarez
Mexico City, Mexico City, Mexico, 14269
Not Yet Recruiting
31
Brain Research Center
Amsterdam, Netherlands, 1081 GM
Not Yet Recruiting
32
New Zealand Brain Research Institute
Christchurch, New Zealand, 8011
Not Yet Recruiting
33
University of Puerto Rico, School of Medicine
San Juan, Puerto Rico, 00936
Actively Recruiting
34
Hospital Clínic I Provincial de Barcelona
Barcelona, Spain, 8036
Not Yet Recruiting
35
The National Hospital for Neurology and Neurosurgery
London, Greater London, United Kingdom, WC1B 3BG
Actively Recruiting
Research Team
J
Jamie Bartzel
CONTACT
E
Ellen Ziegemeier
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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