The Alzheimer's Clinical Trials Consortium (ACTC), established by the National Institute on Aging at the National Institutes of Health, is a clinical trials infrastructure designed to accelerate and expand studies for therapies in Alzheimer's disease (AD) and related dementias.
On 14 July, ACTC, Eisai and Biogen announced that a new Phase III clinical trial has been initiated in the US to evaluate the efficacy and safety of BAN2401, an anti-amyloid beta protofibril antibody, in people with preclinical AD. The AHEAD 3-45 Phase III clinical program includes two trials: the A45 trial and the A3 trial and will be conducted in the US, Japan, Canada, Australia, Singapore, and Europe. A total of 1,400 research participants will receive BAN2401 or placebo for 216 weeks. The A45 trial will enrol cognitively normal participants who have elevated levels of amyloid in the brain and the A3 trial will enrol cognitively unimpaired participants who have an intermediate amount of amyloid in the brain. The design of this new Phase III clinical trial was presented at the Alzheimer's Association International Conference (AAIC) from 27 to 31 July 2020.
In addition, Eisai presented the latest data from its Phase IIb open-label extension study of BAN2401 in early AD at AAIC. The preliminary findings showed a rapid decrease in amyloid levels in the brain after three months of treatment with BAN2401.
