Another new drug for Alzheimer's disease, Phase 3 clinically started.

On July 13th the Alzheimer's Clinical Trials Alliance (ACTC), Eisai and Biogen announced the launch of BAN2401, an anti β stylated protein antibody, for clinical use A new Clinical Phase 3 study (AHEAD 3-45) of individuals with moderate or higher levels of amyloid protein (A beta) in the brain is normal, but preclinical (asymptomatic) Alzheimer's disease (PRECLINICAL AD).
AHEAD 3-45 will be held in the United States, Japan, Canada, Australia, Singapore and Europe.
ban2401 is a humanized anti-β-amyloid protein (A beta) primary fiber antibody.
it can be selectively combined with soluble A-beta-raw fibers (protofibrils).
these primary fibers are fibrous complexes formed by A-beta protein aggregation, which is the intermediate stage in which A-beta proteins accumulate from soluble monogbodies into amyloid protein deposition.
dramatic reversal in the development of a new drug called BAN2401: BAN2401 did not show significant efficacy until 12 months of Phase 2 clinical trials.
, however, at the 18-month node, data analysis showed that BAN2401 not only reduced A-beta deposition in the patient's brain, but also improved cognitive decline in the patient.
launched Phase 3 clinical trials (Clarity AD) in March last year and expects to recruit 1,566 early AD patients to be treated with BAN2401 at a dose of 10 mg/kg.
AHEAD 3-45 is a Clinical Phase 3 study, conducted in collaboration with ACTC and Wes sources funded by the National Institutes of Aging (NIA), part of the National Institutes of Health (NIH).
In AHEAD 3-45, after a regular screening period, participants were included in one of two randomized, double-blind, placebo-controlled trials based on amyloid levels in the brain: the A45 trial and the A3 trial.
1,400 subjects will be included in the study and will be treated with BAN2401 for 216 weeks.
A45 trial will recruit undetagned cognitive participants with elevated amyloid levels in the brain, with the aim of preventing cognitive decline and inhibiting pathological progression in the brain through BAN2401.
endpoint of the A45 was a baseline change in the compound endpoint 5 (PACC5) of preclinical Alzheimer's disease after 216 weeks of treatment.
secondary endpoints were changes in brain amyloid levels compared to baselines measured by amyloid equipment emission fault scans (PET), as well as changes in brain tau protein levels measured by tau-PET and cognitive function indices.
A3 trial will recruit participants with moderate amounts of amyloid protein in the brain who are at risk of further A-beta accumulation.
the main endpoint of A3 is a change in brain amyloid levels compared to the baseline measured by amyloid PET.
secondary endpoint is a change in brain tau levels measured by tau PET over the baseline.
two trials included additional clinical evaluation scales, imaging examinations, blood biomarkers, and cerebrospinal fluid (CSF) as exploratory endpoints.
ATN (Amyloid, Tau protein, neurodegenerative lesions) biomarker group imaging and bioflow (especially cerebrospinal fluid CSF), including A beta 1-42, A beta 1-40, t-Tau, p-Tau, neuroparticular protein, neurosothropological chain, will be used to evaluate the therapeutic effect of AD pathophysiological changes.
"We hope that starting treatment earlier in the course of the disease may help prevent future cognitive decline," he said.
AHEAD3-45 should provide critical answers to the best intervention time for anti-amyloid therapy," said Dr. Reisa Sperling, director of the Alzheimer's Research and Treatment Center at Brigham and Women's Hospital and co-lead researcher at ACTC.
Aisen, director of the Alzheimer's Research Institute at the University of Southern California, which is the ACTC focal point, said, "THE ACTC's mission includes developing public-private partnerships and conducting promising trials of alternative therapies."
AHEAD 3-45 is the type of collaboration we need to work with in the fight against Alzheimer's. Dr Lynn Kramer, Chief Clinical Officer and Chief Medical Officer,
's Neurology Business Unit, said: "This is an exciting time for us to start the AHEAD 3-45 clinical trial of BAN2401 for early stage aD treatment in collaboration with ACTC.
This represents the next step in developing AD precision therapies using biomarkers as part of our human health care mission, and we are committed to bringing change to patients, their families, and healthcare professionals around the world.
: This article is intended to introduce advances in medical and health research, not to recommend treatment options.
if you need guidance on treatment options, visit a regular hospital.
resources: snr. : snr. Of The New Phase III Clinical Study (AHEAD 3-45) Of BAN2401 Preclinical (Asymptomatic) Alzheimer's Disease. Retrieved 2020-07-14, from.