Study of Alzheimer’s Disease in Down Syndrome (LIFE-DSR)
This is an observational, multicenter, longitudinal cohort study to characterize adults with Down syndrome ages 25 years and above enrolled at specialized care centers. The aim is to assess changes in cognition, behavior, function, and health over approximately 24 months.
Blood will be collected for the development of plasma Alzheimer’s disease biomarkers useful in the Down syndrome population.
Phase 2 Study of BIIB092 in Participants With Early Alzheimer's Disease (TANGO)
The primary objective of the placebo-controlled period is 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. The secondary objectives of the placebo-controlled period are 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, and to evaluate the immunogenicity of BIIB092 after multiple doses in participants with MCI due to AD or with mild AD.
The primary objective of the long-term extension period is to evaluate the long-term safety and tolerability of BIIB092 in participants with MCI due to AD or with mild AD.
Safety, Tolerability and Immunogenicity of ACI-24 Vaccine in Adults With Down Syndrome (3 Star)
This is a prospective multi-center, placebo controlled, double-blind and randomized dose escalation study of 2 doses of ACI-24 versus Placebo over 24 months with a total of 21 visits.
All subjects will receive the study medication (ACI-24 or Placebo) 7 times via s.c. injection (12 months) and will be followed up for 12 months after the last dose with a final safety and efficacy assessment.
Safety and Efficacy Study of Gantenerumab in Participants With Early Alzheimer's Disease
This randomized, double-blind, placebo-controlled, parallel group study will evaluate the efficacy and safety of gantenerumab versus placebo in participants with early (prodromal to mild) AD. All participants must show evidence of beta-amyloid pathology.
Eligible participants will be randomized 1:1 to receive either subcutaneous (SC) injection of gantenerumab or placebo. The primary efficacy assessment will be performed at the end of the double blind period at week 104. Participants will then be offered to enter into an open-label extension (OLE). Participants not willing to go to the OLE will participate in a long term follow-up period for up to 50 weeks after the last gantenerumab dose.