Skip to main content

Dominantly Inherited Alzheimer Network Trial Unit (DIAN-TU)

Recruiting

This ongoing study is assessing the safety, tolerability, and efficacy of investigational treatments in people who have a genetic mutation for autosomal-dominant Alzheimer's disease. If no treatment group is enrolling, the study offers an observational component until enrollment is available.

Minimum Age Maximum Age Gender Healthy Volunteers
18 Years 80 Years All Yes
December 2012
March 2021
490

  • Have a genetic mutation that causes Alzheimer's disease or are a family member with an autosomal-dominant Alzheimer's disease mutation
  • No more than 10 years after the predicted or actual age of cognitive symptom onset
  • Cognitively normal or with mild cognitive impairment or mild dementia (Clinical Dementia Rating score of 0 to 1)
  • Fluency in trial-approved language and adequate intellectual functioning (aside from mild impairment)
  • Able to undergo magnetic resonance imaging (MRI), lumbar puncture, and positron emission tomography and to complete all study-related testing and evaluations
  • Females of childbearing potential must agree to use effective contraception if partner is not sterile
  • Visual and hearing abilities adequate to complete cognitive and functional assessments
  • Study partner who can attend visits and provide information on participant's cognitive and functional abilities

  • Evidence of significant abnormality on brain MRI scans
  • Alcohol or drug dependence within past year
  • Pacemakers, aneurysm clips, artificial heart valves, ear implants, or foreign metal objects in the eyes, skin, or body that would prevent MRI
  • History or presence of significant cardiovascular disease, liver/kidney disorders, infectious disease or immune disorder, or metabolic/endocrine disorders
  • Taking anticoagulants; low-dose aspirin (325 mg or less) is allowed
  • Exposed to a monoclonal antibody-targeting beta-amyloid peptide within past 6 months
  • Cancer in last 5 years, except basal cell carcinoma, nonsquamous skin carcinoma, prostate cancer, or carcinoma in situ with no significant progression in past 2 years
  • Positive pregnancy test or plans to become pregnant during the trial period

Mutations in presenilin 1 (PSEN1), presenilin 2 (PSEN2), and amyloid precursor protein (APP) genes are associated with dominantly inherited Alzheimer's disease. This Phase II/III study will target individuals who are either known to have one of these disease-causing mutations or who are unaware of their genetic status but have a parent or sibling with a known genetic mutation. Investigators will be testing several different therapies for their potential to slow cognitive impairment and improve disease-related biomarkers

Although there are differences between early-onset familial Alzheimer's disease and the more common age-associated sporadic disease, the results of this study will have implications for future studies and treatments in late-onset Alzheimer's.

For more information about this study or study sites, visit the study website, call 1-844-342-6397, or email dianexr@wustl.edu.

Name City State Zip Status Primary Contact
University of Alabama in Birmingham
Birmingham Alabama 35294 Active, not recruiting

University of California San Diego Medical Center
La Jolla California 92037 Active, not recruiting

USC Keck School of Medicine
Los Angeles California 90033 Not yet recruiting

Yale University School of Medicine
New Haven Connecticut 06510 Active, not recruiting

Emory University
Atlanta Georgia 30329 Recruiting

Advocate Lutheran General Hospital
Park Ridge Illinois 60068 Recruiting

Indiana University School of Medicine
Indianapolis Indiana 46202 Recruiting

Washington University in St. Louis
Saint Louis Missouri 63110 Recruiting

Columbia University
New York New York 10032 Active, not recruiting

University of Pittsburgh
Pittsburgh Pennsylvania 15213 Active, not recruiting

Butler Hospital
Providence Rhode Island 02096 Recruiting

Texas Health Hospital
Arlington Texas 76011 Recruiting

University of Washington
Seattle Washington 98195 Recruiting

UBC Hospital
Vancouver British Columbia V6T 2B5 Active, not recruiting

Sunnybrook Health Sciences Centre
Toronto Ontario M4N 3M5 Active, not recruiting

CHU de Quebec - Hôpital de l' Enfant Jésus
Québec City Quebec G1J 1Z4 Active, not recruiting

McGill Center for Studies in Aging
Verdun Quebec H4H 1R3 Active, not recruiting

Instituto Nacional de Neurologia y Neurocirugia Manuel Velasco Suarez
Mexico City México 14269 Not yet recruiting

Washington University School of Medicine

  • Eli Lilly and Company
  • Hoffmann-La Roche
  • Alzheimer's Association
  • National Institute on Aging (NIA)
  • Avid Radiopharmaceuticals
  • Accelerating Medicines Partnership (AMP)
  • Janssen, LP

Name Role Affiliation
Randall J Bateman, MD Study Director Washington University School of Medicine

Name Phone Email
Ellen Ziegemeier, MA 844-DIANEXR (342-6397) dianexr@wustl.edu
Jennifer Petranek 844-DIANEXR (342-6397) dianexr@wustl.edu

NCT01760005

A Phase II/III Randomized, Double-Blind, Placebo-Controlled, Cognitive Endpoint, Multi-Center Study of Potential Disease Modifying Therapies in Individuals at Risk for and With Dominantly Inherited Alzheimer's Disease