Actively Recruiting
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
Led by Washington University School of Medicine · Updated on 2026-02-13
280
Participants Needed
35
Research Sites
509 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 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.
CONDITIONS
Official Title
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
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
- Participant is at least 18 years old
- People who can become pregnant must have a negative pregnancy test at screening
- Agree not to become pregnant or breastfeed during the study until 5 half-lives after the last dose
- Agree to use effective contraception if applicable from screening until 5 half-lives after last dose
- Carrier of APP, PSEN1, or PSEN2 mutation linked to DIAD or at direct risk through family mutation
- Within 25 to 11 years before predicted age of cognitive symptom onset based on mutation or family history
- Normal cognitive status (CDR-SB 0)
- Fluent in DIAN-TU approved language with adequate premorbid intellectual functioning
- Adequate visual and hearing abilities for assessments
- Stable medication doses for non-excluded conditions for at least 30 days before baseline except episodic medications
- Has a study partner able to provide accurate cognitive and functional information and signs consent
- Agree not to donate blood or blood products during the study and for 5 half-lives after last dose
- Likely to comply and complete the study
- Able and willing to complete all study testing and procedures
You will not qualify if you...
- Significant neurologic or psychiatric diseases that affect cognition or study participation
- High risk for suicide or recent major depression
- History of stroke or significant stroke risk factors impacting cognition or study ability
- Alcohol or substance use disorder within past year
- Brain MRI showing significant abnormalities such as microhemorrhages or aneurysms
- Implanted medical devices incompatible with MRI
- Cardiovascular conditions interfering with study participation
- Liver or kidney problems interfering with study participation
- History of HIV, recent Hepatitis B or untreated Hepatitis C, or CNS infections
- Severe drug allergies or hypersensitivity reactions related to study drugs or imaging agents
- Recent immunosuppressive or chemotherapy treatments
- Thyroid abnormalities or significant vitamin B12 deficiency
- Unstable or poorly controlled diabetes
- Morbid obesity affecting MRI imaging
- Current use of anticoagulants except low dose aspirin
- Recent exposure to monoclonal antibodies targeting amyloid beta
- Recent use of other investigational drugs
- Insufficient venous access
- Abnormal hematology, coagulation, or clinical chemistry
- History of cancer with high risk of recurrence impacting participation
- Any other medical condition that may bias assessments or increase risk
- Recent participation in other clinical studies without approval
- Participants with the "Dutch" APP E693Q mutation
- Unable to complete baseline procedures with required cognitive and clinical scores
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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