Alzheimer’s Disease Trial of Solanezumab

  • Study Director: Adam Boxer, MD, PhD
  • Sponsor: Eli Lilly & Company
  • Recruiting? Not recruiting
  • Official Study Title: Effect of Passive Immunization on the Progression of Mild Alzheimer’s Disease: Solanezumab (LY2062430) Versus Placebo
  • ClinicalTrials.gov Identifier: NCT01900665
  • Conditions Studied: Mild Alzheimer’s disease
  • Intervention Drugs: Solanezumab (LY2062430) and placebo control. Study drug (Solanezumab or placebo) is administered as an intravenous infusion, once every 4 weeks.
  • Phase: Phase 3
  • Duration of Participation: Approximately 18 months

Purpose of the Study

The production and deposition of amyloid plaques in the brain are thought to contribute to the development and progression of Alzheimer’s disease (AD). Solanezumab is hypothesized to reduce accumulation of amyloid plaques and thus slow the progression of AD. The primary purpose of the study is to determine if Solanezumab will slow cognitive and functional decline in participants with mild AD.

Eligibility

Inclusion Criteria: Subjects must be between the ages of 55 and 90 years old, and meet diagnostic criteria for probable Alzheimer’s disease. Subjects must also have a Mini Mental State Examination (MMSE) score of 20 through 26 at the screening visit. Subjects must be willing and able to have brain MRIs, and have a florbetapir PET scan consistent with the presence of amyloid pathology at screening. Subjects must have a reliable caregiver who has at least 10 hours of contact with them per week and is willing to complete study-related questionnaires.

Exclusion Criteria: Subjects must not meet diagnostic criteria for vascular dementia, or have a current serious or unstable illness that could interfere with analyses of safety and efficacy of the study. Subjects must also not have a history of a serious infectious disease affecting the brain, head trauma resulting in protracted loss of consciousness, primary or recurrent malignant disease, human immunodeficiency virus or substance dependence. Subjects should not have allergies to humanized monoclonal antibodies, severe drug allergies or severe posttreatment hypersensitivity reactions. Subjects must not be currently enrolled in another clinical trial.

What to Expect

Testing: Brain MRIs, florbetapir PET scans, neurological and physical examinations, cognitive testing and neuropsychiatric assessments, ECGs, blood and urine specimen collection, vital signs, lumbar puncture (optional addendum study).

The Frequency of Visits:

  • 28-day screening period
  • Visits once every 4 weeks, for 76 weeks
  • One follow-up visit, 4 weeks after the end of the study treatment period

Materials Needed Before Evaluation: Diagnosis of probable Alzheimer’s disease according to the National Institute of Neurological and Communicative Disorders and Stroke/Alzheimer’s Disease and Related Disorders Association (NINCDS/ADRDA) criteria

Costs: No costs will be charged for any of the study procedures. Parking will be validated at the 1625 Owens Street Garage or 1630 Third Street Garage at the UCSF Mission Bay campus and at the China Basin campus for all study visits. Subjects will be reimbursed $50 per visit for meal and travel expenses.

Contact Information

Clinical Trials Nurse: Mary Koestler, RN, PhD, CCRC – Mary.Koestler@ucsf.edu, 415.476.0661