Asymptomatic Alzheimer’s Disease Anti-Amyloid Trial

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Summary

  • Study director: Adam Boxer, MD, PhD
  • Sponsor: Eli Lilly & Company and National Institute on Aging (NIA)
  • Recruiting?: Yes
  • Official study title: Anti-Amyloid Treatment in Asymptomatic Alzheimer’s Disease (A4 Study)
  • ClinicalTrials.gov identifier: NCT02008357
  • Conditions studied: Older individuals who may be at risk for memory loss
  • Intervention Drugs: Solanezumab and placebo control. Study drug (solanezumab or placebo) is administered as an intravenous infusion, every 4 weeks for 168 weeks.
  • Phase: Phase 3
  • Purpose: The purpose of this study is to test whether an investigational drug called solanezumab can slow the progression of memory problems associated with brain amyloid (the protein that forms plaques in the brains of people with Alzheimer’s disease) as compared with placebo in subjects with preclinical AD.
  • Duration of participation: Up to 90 day screening period and 168 week treatment period

Eligibility

  • Inclusion criteria: Subjects must be between 65–85 years of age (inclusive) and at screening have a Mini Mental State Examination (MMSE) score of 27–30 for subjects with high educational attainment (13 or more years of education) or 25–30 for subjects with low educational attainment (12 or fewer years of education). Subjects must have a Florbetapir PET scan at screening that shows evidence of brain amyloid pathology. Subjects must be on a stable dose of permitted medications for 6 weeks prior to the first infusion. Subjects must have a study partner who is willing to participate as a source of information and has at least weekly contact with the subject.
  • Exclusion criteria: Subjects must not be receiving acetylcholinesterase inhibitors (AChEI) and/or memantine at screening. Subjects must not lack good venous access. Subjects must not have any current serious or unstable illness including cardiovascular, hepatic, renal, respiratory, neurologic, psychiatric, or other conditions that could interfere with the study. Subjects must not have a history within the last 5 years of a serious infectious disease affecting the brain or head trauma resulting in loss of consciousness. History within the past 5 years of chronic alcohol or drug abuse and history within the past 2 years of major depression or bipolar disorder. Subjects must not have a history of schizophrenia or be at a serious risk for suicide.

What is involved?

  • Testing: Brain MRIs, Florbetapir PET scans, lumbar punctures (optional), neurological and physical examinations, cognitive testing and neuropsychiatric assessments, ECGs, blood and urine specimen collection, vital signs
  • Frequency of visits:
    • Up to 90-day screening period
    • Visits once every 4 weeks for 168 weeks (“treatment period”)
    • Potential open-label treatment options following the treatment period
  • Materials needed prior to evaluation: No previous diagnosis of cognitive impairment
  • Costs: No costs will be charged for any of the study procedures. Parking will be validated for the UCSF public garages for all study visits, and subjects will be reimbursed between $75–200 depending on the kind of visit. Study partners will be paid $50 for each visit that they attend with the study subject.

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