Alzheimer’s Disease/Dementia News

The manufacturer of Leqembi announced it has submitted a supplemental Biologics License Application to the FDA to support the conversion of its recent accelerated approval to a traditional approval.

The FDA has determined that the supplementary new drug application for brexpiprazole, a drug to treat agitation associated with Alzheimer’s dementia, is sufficiently complete to permit a substantive review, according to the manufacturers.

Quanterix Corp. announced the validation of a laboratory developed test to quantitatively measure neurofilament light chain in serum as an aid in the evaluation of those who may have neurodegenerative conditions.

Amyloid positron emission tomography scan changes were similar between individuals with autosomal dominant Alzheimer’s disease and those with Down syndrome, researchers reported in The Lancet Neurology.

The FDA has granted accelerated approval for Leqembi for the treatment of Alzheimer’s disease, making it the second approved Alzheimer’s treatment, the agency announced in a press release.

AriBio USA Inc. announced the enrollment of the first participants in a phase 3 trial to evaluate the efficacy of a novel therapeutic to treat those with early Alzheimer’s disease.

Athira Pharma Inc. will proceed in 2023 with several clinical trials for treatments for Alzheimer’s disease, Parkinson’s disease and ALS, the biopharmaceutical company announced in a press release.

Adults with elevated serum sodium in middle age, a marker of inadequate fluid intake, were more likely to be biologically older than their chronological age and develop chronic diseases compared with adequately hydrated adults, data show.

A congressional investigation found the FDA’s interactions with Biogen were “atypical and failed to follow” protocol and that the two “inappropriately collaborated” on documentation before the approval of Aduhelm for Alzheimer’s disease.

A biopharmaceutical company and the Miller School of Medicine at the University of Miami have announced a partnership to conduct a phase 1/2a clinical trial of ALZN002, a treatment for Alzheimer’s-related dementia.