Alzheimer's Disease Education and Referral Center

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 international 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 AgeMax AgeGenderHealthy 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.

Central Contact Information: 

For more information about this trial, please contact Ellen Ziegemeier at 1-844-342-6397 or Dianexr@wustl.edu.

Locations: 
Map Marker CityStateZip CodeStatusPrimary Contact

Geolocation is 33.5075555, -86.8093239

Site
Birmingham
Alabama
35294
Recruiting
Name:
Phone:

Geolocation is 32.8328112, -117.2712717

Site
La Jolla
California
92037
Not yet recruiting
Name:
Phone:

Geolocation is 34.070264, -118.4440562

Site
Los Angeles
California
90095
Not yet recruiting
Name:
Phone:

Geolocation is 37.7748363, -122.3872576

Site
San Francisco
California
94158
Not yet recruiting
Name:
Phone:

Geolocation is 41.3052226, -72.9268626

Site
New Haven
Connecticut
06510
Recruiting
Name:
Phone:

Geolocation is 33.828105, -84.3279093

Site
Atlanta
Georgia
30329
Recruiting
Name:
Phone:

Geolocation is 39.7794767, -86.1700894

Site
Indianapolis
Indiana
46202
Recruiting
Name:
Phone:

Geolocation is 38.6212468, -90.2526163

Site
Saint Louis
Missouri
63110
Recruiting
Name:
Phone:

Geolocation is 40.8409822, -73.9447994

Site
New York
New York
10032
Recruiting
Name:
Phone:

Geolocation is 40.4379259, -79.9556424

Site
Pittsburgh
Pennsylvania
15213
Recruiting
Name:
Phone:

Geolocation is 41.8267223, -71.4074266

Site
Providence
Rhode Island
02096
Recruiting
Name:
Phone:

Geolocation is 49.2650543, -123.2459921

Site
Vancouver
British Columbia
V6T 2B5
Not yet recruiting
Name:
Phone:

Geolocation is 43.7215696, -79.3768256

Site
Toronto
Ontario
M4N 3M5
Not yet recruiting
Name:
Phone:

Geolocation is 45.4420201, -73.5800493

Site
Verdun
Quebec
H4H 1R3
Not yet recruiting
Name:
Phone:
Lead Sponsor: 
Agency
Washington University School of Medicine
Collaborator Sponsor: 
Agency
Eli Lilly and Company
Hoffmann-La Roche
Alzheimer's Association
National Institute on Aging
Avid Radiopharmaceuticals
Facility Investigators: 
NameRoleAffiliation
Randall J. Bateman, MD
Study Director
Washington University in St. Louis
Study Contact: 
NamePhoneEmail
Ellen Ziegemeier
844-342-6397
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: 
March 2017
Disease Stage: 
Pre-clinical
Early
Enrollment: 
210