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Phase 2 Study of BIIB092 in Participants With Early Alzheimer's Disease (TANGO)
||Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Assess the Safety, Tolerability, and Efficacy of BIIB092 in Subjects With Mild Cognitive Impairment Due to Alzheimer's Disease or With Mild Alzheimer's Disease
||Henry Querfurth, MD, PhD
To evaluate the safety and tolerability of BIIB092 in participants with mild cognitive impairment (MCI) due to Alzheimer's disease (AD) or with mild AD. To evaluate the efficacy of multiple doses of BIIB092 in slowing cognitive and functional impairment in participants with MCI due to AD or with mild AD. To evaluate the immunogenicity of BIIB092 after multiple doses in participants with MCI due to AD or with mild AD
- Must have a gradual and progressive change in memory function over more than 6 months.
- Must meet all of the clinical criteria for mild cognitive impairment (MCI) due to Alzheimer's disease (AD) or mild AD
- Must have objective evidence of cognitive impairment at Screening
- Clinically significant, unstable psychiatric illness
- Have had a stroke or Transient Ischemic Attack (TIA) or unexplained loss of consciousness in the past 1 year
- Indication of impaired renal or liver function
Three screening visits, followed by 22 study visits including IV infusions of the experimental agent, blood draws (at 11 of the 22 visits), and neurocognitive testing. 90 week participation total. Study includes 4 PET scans and 4 MRIs.