Dominantly Inherited Alzheimer Network Trial: An Opportunity to Prevent Dementia
A Study of Potential Disease Modifying Treatments in Individuals at Risk for or With a Type of Early Onset Alzheimer's Disease Caused by a Genetic Mutation (Protocol #DIAN-TU-001)
Description: A study designed to assess Gantenerumab and Solanezumab in individuals who have an autosomal dominant Alzheimer's disease (ADAD) mutation.
Enrollment Period: December 2012 through July 2014 (approximately)
Study Participation/Requirement Summary:- Monthly visits: drug administration (in-home or at DIAN site)
- Every 3 months: MRI
- Every 6 months: brief cognitive testing & Electrocardiograph (ECG)
- Annual visit (initial, year 1, year 2): ~4 day visit including cognitive testing, brain scans, blood, and CSF collection at a DIAN site.
Inclusion (eligibility) Criteria for the trial:
- - Individuals at risk of having an autosomal dominant Alzheimer's disease (ADAD) mutation (e.g. parent or sibling with a known AD-causing mutation). Note, a participant does not need to know their mutation status.
- Cognitively normal or with mild cognitive impairment or mild dementia
- For women of childbearing potential, effective contraceptive measures must be used if partner is not sterilized. Men must agree to use effective contraceptive measures.
- Has a Study Partner, who agrees to provide information for the study visits.
This study is sponsored by Washington University School of Medicine in collaboration with Eli Lilly Company, Hoffmann-La Roche, and the Alzheimer’s Association.
Additional information regarding this study can be found at Clinicaltrials.gov (ID#: NCT01760005) or through the following link: http://clinicaltrials.gov/ct2/show/NCT01760005