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 launched in December 2017. This network of 35 sites across the US is designed to accelerate and expand studies for therapies in Alzheimer's disease (AD) and related dementias.
ACTC has recently announced that Elenbecestat and BAN2401, two potential anti-amyloid therapies currently being evaluated as treatments for early AD, have been selected for two upcoming clinical studies targeting primary prevention (A3 Study) and secondary prevention (A45 Study) of AD. Being jointly developed by Eisai and Biogen, both studies are expected to start early next year. The A3 study will test whether a BACE inhibitor can slow brain amyloid accumulation at the very early stage of the disease. It will be a global, multicenter, double-blind and randomised trial comparing the effects of two doses of Elenbecestat in cognitively normal participants who have non-elevated amyloid levels but are at high risk for further Aβ accumulation.
The A45 study is designed to target the preclinical (pre-symptomatic) stage of AD and plans to enrol clinically normal participants with no/minor cognitive impairment who have elevated levels of amyloid in the brain and are at high risk for progression to mild cognitive impairment and AD dementia. It will be a global, multicenter, double-blinded, placebo-controlled and randomised trial evaluating the combination’s ability of BAN2401 and Elenbecestat to prevent cognitive decline and delay biomarkers of pathological progression.
"The A3 and A45 Studies should provide critically important answers about the optimal time to intervene with anti-amyloid therapy, with the hope that starting treatment much earlier in the disease process may be advantageous in preventing future cognitive decline," said Dr. Sperling, Director, Center for Alzheimer Research and Treatment at Brigham and Women's Hospital and co-Principal Investigator, ACTC.
