Dominantly Inherited Alzheimer Network Trial Unit (DIAN-TU)

What Is This Study About?

This ongoing study is testing the safety and effectiveness of several experimental drugs to slow the progression of cognitive impairment in people with an inherited Alzheimer's disease-causing gene mutation. Specifically, mutations in presenilin 1 (PSEN1), presenilin 2 (PSEN2), and amyloid precursor protein (APP) genes are associated with inherited Alzheimer's disease. All participants will be tested to determine if they have one of the mutations. Participants found to have one of the mutations will be randomly assigned to receive injections of one of the study drugs. Those participants who do not have a mutation will be randomly assigned to receive injections of either a study drug or a placebo. Injections will be given every four weeks for up to 208 weeks. Researchers will measure changes in cognition, blood and spinal fluid biomarkers, abnormal amyloid and tau protein in the brain, and brain glucose metabolism. Measurements will be done at the start of the study and then again at weeks 52, 104, 156, and 208. The study, called DIAN-TU, will test several different study drugs, starting with gantenerumab and solanezumab.

Do I Qualify To Participate in This Study?

Must have:

• Have a genetic mutation that causes Alzheimer's disease or are a family member with an dominantly inherited Alzheimer's disease (DIAD) 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

Must NOT have:

• 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

If I Qualify, Who Do I Contact?

Contact study personnel listed either under the general study contact or the location nearest you.

 

Who Is the General Study Contact?

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

Where Is This Study Located?

Alabama
University of Alabama in Birmingham Birmingham, AL 35294 Recruiting
California
University of California San Diego Medical Center La Jolla, CA 92037 Recruiting
USC Keck School of Medicine Los Angeles, CA 90033 Recruiting
Georgia
Emory University Atlanta, GA 30329 Recruiting
Illinois
Advocate Lutheran General Hospital Park Ridge, IL 60068 Recruiting
Indiana
Indiana University School of Medicine Indianapolis, IN 46202 Recruiting
Missouri
Washington University in St. Louis Saint Louis, MO 63110 Recruiting
Pennsylvania
University of Pittsburgh Pittsburgh, PA 15213 Recruiting
Rhode Island
Butler Hospital Providence, RI 02096 Recruiting
Texas
Texas Health Hospital Arlington, TX 76011 Recruiting
Washington
University of Washington Seattle, WA 98195 Recruiting

Who Sponsors This Study?

Lead: Washington University School of Medicine

Collaborator Sponsor

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

Source: ClinicalTrials.gov ID: NCT01760005