Trial Information

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.

Sponsor Information:
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