None listed
Conditions
Brief summary
The Anti-Amyloid Treatment in Asymptomatic Alzheimer’s Disease study (the “A4 study”) is a clinical trial testing an anti-amyloid investigational drug (called solanezumab, also known as LY2062340) in older individuals who have evidence of elevated amyloid build-up in their brains, but who do not yet show symptoms of AD. The primary purpose of this study is to test whether solanezumab can slow possible AD-related damage in the brain and to delay progression of AD-related memory loss associated with brain amyloid.
Interventions
400 mg solanezumab/placebo per intravenous infusion, four weekly for 3 years. Safety assessments: blood, MRI, ECG at intervals throughout the study.
Sponsors
The FIL Foundation (FIL Investment Management Limited)
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
65 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
[1]Male or female ages 65 to 85 years old. [2] Has an MMSE score at screening of 25 to 30. [3] Has a global CDR score at screening of 0. [4] Has a Logical Memory II score at screening of 6 to 18. [5] Has a florbetapir PET scan that shows evidence of brain amyloid pathology at Visit 2. [6] In general, permitted medications should be stable for 6 weeks prior to baseline (visit 6)
Exclusion criteria
[1] Is receiving a prescription acetylcholinesterase inhibitor (AChEI) and/or memantine at screening (Visit 1) or baseline (Visit 6). [2] Lacks good venous access, such that intravenous drug delivery or multiple blood draws would be precluded. [3] Has current serious or unstable illness including cardiovascular, hepatic, renal, gastroenterologic, respiratory, endocrinologic, neurologic, psychiatric, immunologic, or hematologic disease or other conditions that, in the investigator’s opinion, could interfere with the analyses of safety and efficacy in this study. [4] Has had a history within the last 5 years of a serious infectious disease affecting the brain (including neurosyphilis, meningitis, or encephalitis) or head trauma resulting in protracted loss of consciousness. [5] Has had a history within the last 5 years of a primary or recurrent malignant disease with the exception of resected cutaneous squamous cell carcinoma in situ, basal cell carcinoma, cervical carcinoma in situ, or in situ prostate cancer with normal prostate-specific antigen posttreatment. [6] Has allergies to humanized monoclonal antibodies.
Outcome results
None listed