Multicenter Clinical Trial Site Set Up
LOCATION: 44 Adams Street #4, Braintree MA 02184 USA
Alzheimer’s disease (AD) is a fatal neurodegenerative disease that is manifested by progressive cognitive deficits including memory loss followed by loss of independent function as well as neuropsychiatric symptoms such as apathy, depression, anxiety, agitation and psychosis. Multicenter trials are ongoing using several humanized monoclonal anti-tau and anti-amyloid antibodies which binds to phosphorylated tau (P-tau) or amyloid in the brain to remove these proteins. We will evaluate whether these can slow cognitive decline in participants with Early AD with evidence of elevated brain tau (T+) and / or amyloid (A+) and assess its safety and tolerability. These studies typically consists of: screening period (13-25 weeks), double‑blind treatment period (36 to 232 weeks), and a follow‑up period (2 to 48 weeks). Safety and tolerability assessments will include adverse events (AEs), vital signs, electrocardiogram (ECG), early discontinuations, physical and neurological examinations, safety laboratory evaluations, suicidality risks (Columbia Suicide Severity Rating Scale [CSSRS]) and brain MRI will be performed during the protocol.