Tau Positron Emission Tomography in Autosomal Dominant Alzheimer Disease: Small Windows, Big Picture.
Eric McDade, Randall J Bateman
https://pubmed.ncbi.nlm.nih.gov/29435570Actively Recruiting
Phase 2
Phase 3
Age: 18Years +
All Genders
Healthy Volunteers
ID06647498
A Phase II/III Randomized, Double-Blind, Placebo-Controlled Trial of Remternetug for Primary Prevention in Dominantly Inherited Alzheimer's Disease
Led by Washington University School of Medicine · Updated on 2026-02-13
280
Participants Needed
35
Research Sites
21 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
Researchers are studying remternetug, a potential treatment for asymptomatic individuals who carry genetic mutations causing dominantly inherited Alzheimer's disease (DIAD). The study aims to evaluate the drug's effect on amyloid beta accumulation, biomarkers of the disease, safety, and tolerability. This trial includes two stages: the first to see if remternetug prevents or reverses amyloid buildup, and the second to assess its impact on other Alzheimer's-related biomarkers compared to control groups. Participants will receive remternetug or a matching placebo by subcutaneous injection every 12 weeks during Stage 1. After completing Stage 1, an open-label phase will begin where all participants may receive remternetug. The study uses a randomized, double-blind, placebo-controlled design to carefully evaluate treatment effects over time. During the study, participants undergo brain scans, blood and spinal fluid tests, and cognitive assessments to monitor disease markers and subtle cognitive changes. Researchers will measure amyloid levels using PET imaging and analyze changes in cerebrospinal fluid biomarkers and brain MRI volumes. Safety and tolerability will be closely monitored, and participants are involved for up to 192 weeks with regular evaluations throughout the trial.
CONDITIONS
Brief 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
Age: 18Years +
All Genders
Healthy Volunteers
Eligibility Criteria
You may qualify if you...
- Provide written informed consent and have a study partner who agrees to participate
- Be at least 18 years old
- For people who can become pregnant, have a negative pregnancy test at screening and agree to use effective contraception during the study
- Carry a mutation in APP, PSEN1, or PSEN2 gene linked to dominantly inherited Alzheimer's disease, or have a family mutation risk
- Be 11 to 25 years before predicted age of cognitive symptom onset
- Have normal cognitive status (Clinical Dementia Rating Sum of Boxes score 0)
- Be fluent in a study-approved language and able to complete cognitive and clinical assessments
- Have adequate vision and hearing for study assessments
- Be on stable medication doses for at least 30 days prior to baseline visit except for episodic conditions
- Agree not to donate blood during the study and for a defined period afterward
- Be able and willing to complete all study procedures
You will not qualify if you...
- Have significant neurological or psychiatric diseases affecting cognition or study participation, including recent severe head trauma or major psychiatric disorders
- Be at high risk for suicide or have current major depression
- Have history of stroke or significant vascular risk factors affecting cognition
- Have alcohol or substance use disorder within the past year
- Have brain MRI abnormalities such as microhemorrhages or aneurysms
- Have certain implanted medical devices that prevent MRI scans
- Have uncontrolled cardiovascular, hepatic, or renal conditions
- Have history of HIV, recent hepatitis B or untreated hepatitis C, or other CNS infections
- Have severe drug allergies or hypersensitivity reactions
- Have used immunosuppressive medications or chemotherapeutics recently
- Have clinically significant thyroid or vitamin B12 abnormalities
- Have unstable diabetes or morbid obesity affecting MRI
- Use anticoagulants other than low-dose aspirin
- Have prior exposure to amyloid-targeting monoclonal antibodies or investigational treatments recently
- Have insufficient venous access or abnormal blood test results
- Have history of high-risk cancer
- Have any other medical conditions or factors that may interfere with study or increase risk
- Have participated in another clinical study recently without approval
- Have the "Dutch" APP E693Q mutation
- Are investigator site personnel or employees related to the trial or their immediate families
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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2
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Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - Up to 192 weeks
Participants receive Remternetug or placebo by subcutaneous injection every 12 weeks to evaluate its effect on amyloid plaque and Alzheimer's disease progression.
Injections every 12 weeks with assessments at baseline, week 48, week 96, week 144, and week 192
Treatment
Duration - Duration following Stage 1 until study completion
Participants who complete Stage 1 may receive open-label Remternetug treatment to further evaluate effects on biomarkers and cognitive function.
Assessments at weeks 0, 48, 96, 144, and 192 during open-label treatment
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
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Research Team
J
Jamie Bartzel
E
Ellen Ziegemeier
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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