Dominantly Inherited Alzheimer Network Trial: An Opportunity to Prevent Dementia (DIAN TU)
Dominantly Inherited Alzheimer Network Trial: An Opportunity to Prevent Dementia (DIAN TU)
Overall Status:
Recruiting
Brief Description:
This study will assess the safety, tolerability, and biomarker efficacy of the drugs gantenerumab and solanezumab in individuals who have a genetic mutation for autosomal-dominant Alzheimer's disease.
Patient Qualifications:
| Min Age | Max Age | Gender | Healthy Volunteers |
|---|---|---|---|
18 Years | 80 Years | Both | Yes |
Inclusion Criteria:
- Individuals who know they have a genetic mutation that causes Alzheimer's disease or are unaware of their genetic status and have a 50 percent chance of having an autosomal-dominant Alzheimer's disease mutation (parent or sibling has a known Alzheimer's-causing mutation)
- Age within 15 years before to 10 years after parent's age of symptom onset
- Cognitively normal or with mild cognitive impairment or mild dementia; Clinical Dementia Rating of 0-1 (inclusive)
- Able to undergo magnetic resonance imaging, lumbar puncture, positron emission tomography and to complete all study-related testing and evaluations
- Women of childbearing potential must agree to use effective contraceptive measures if partner is not sterilized; men must agree to use effective contraceptive measures
- Adequate seeing and hearing ability to perform all cognitive and functional assessments
- Study partner who can provide accurate information about the subject's cognitive and functional abilities at study visits and who signs the necessary consent form
Exclusion Criteria:
- History or presence of brain MRI scans indicative of significant abnormality other than Alzheimer's disease
- Presence of pacemakers, aneurysm clips, artificial heart valves, ear implants, or foreign metal objects in the eyes, skin, or body
- History or presence of clinically significant cardiovascular disease, hepatic/renal disorders, infectious diseases or immune disorders, or metabolic/endocrine disorders
- Taking anticoagulants; low-dose aspirin (325 mg or less) is acceptable
- Exposed to a monoclonal antibody-targeting beta-amyloid peptide within the past 6 months
- History of cancer within the last 5 years, except basal cell carcinoma, nonsquamous skin carcinoma, prostate cancer, or carcinoma in situ with no significant progression over the past 2 years
- Positive urine or serum pregnancy test or plans to become pregnant during the course of the trial
Detailed Description:
This Phase II/III study will target individuals who are either known to have a genetic mutation that causes autosomal-dominant Alzheimer's disease or who are unaware of their genetic status but have a parent or sibling with a known genetic mutation. Many of these high-risk participants will not yet have any symptoms of Alzheimer's. Investigators will test two experimental drugs, gantenerumab and solanezumab, to assess their safety, side effects, and effect on imaging and fluid biomarkers. Subtle, early changes in cognition will also be evaluated, though participants at this disease stage are unlikely to have more than minimal changes in cognitive measures during the study.
Because many at-risk individuals decide not to know whether they have an Alzheimer's-associated genetic mutation, some of the participants in this study will not have the disease-causing mutations. These "mutation-negative" individuals will be assigned to the placebo group. Other participants will receive one of two different therapies, gantenerumab or solanezumab. Gantenerumab is a monoclonal antibody that will be given subcutaneously (via an injection under the skin) every 4 weeks. Solanezumab is another monoclonal antibody, which will be given as an intravenous infusion every 4 weeks.
Participants and study staff will know which treatment group each participant has been assigned to. However, they will be blinded as to whether participants receive an active drug or a placebo. At the end of the study period, the sponsors will consider developing an extension study that would allow participants to continue a longer therapeutic trial with cognitive endpoints.
Although there are differences between dominantly inherited 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 sporadic Alzheimer's.
Locations:
| Map Marker | City | State | Zip Code | Status | Primary Contact | |
|---|---|---|---|---|---|---|
Geolocation is 38.6212468, -90.2526163 | Washington University | Saint Louis | Missouri | 63110 | Recruiting |
Lead Sponsor:
| Agency |
|---|
Washington University School of Medicine |
Collaborator Sponsor:
| Agency |
|---|
Eli Lilly and Company |
Hoffmann-La Roche |
Alzheimer's Association |
Facility Investigators:
| Name | Role | Affiliation |
|---|---|---|
Randall J. Bateman, MD | Study Director | Washington University in St Louis |
Study Contact:
| Name | Phone | |
|---|---|---|
Denise Levitch | 800-747-2979 |
Locations
ClinicalTrials.gov ID
NCT01760005 (follow link to view full record on ct.gov in new window)
Official Title:
A Phase II/III Randomized, Double-Blind, Placebo-Controlled Multi-Center Study of 2 Potential Disease Modifying Therapies in Individuals at Risk for and With Dominantly Inherited Alzheimer's Disease
Study Start Date:
December 2012
Study End Date:
December 2016
Disease Stage:
Pre-clinical
Early
Enrollment:
210
Trial References:
