Alzheimer's Disease
Alzheimer’s as an autoimmune disease: ‘We will need competence in the area of immunology’
What if Alzheimer’s disease, a neurological disorder that has confounded researchers since its identification in 1907, were not a brain disorder at all? What if it were instead an autoimmune disease that attacks the brain?
Smoking cessation, rather than reduction, linked to lower risk for dementia
Smoking cessation was associated with lower risk for dementia, including Alzheimer’s disease and vascular dementia, compared with sustained or even reduced smoking intensity, researchers reported in JAMA Network Open.
FDA requests more data on Alzheimer's treatment candidate donanemab
The FDA issued a complete response letter on the accelerated approval of donanemab for treatment of early symptomatic Alzheimer’s disease, citing the limited number of patients with longer drug exposure data.
Hormone therapy in perimenopause may protect against Alzheimer’s disease
Hormone therapy may promote better memory and cognitive function and larger brain volumes among women carrying APOE4, a genetic risk factor for Alzheimer’s disease.
Eisai submits supplemental application to FDA for traditional approval of Leqembi
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.
FDA rules sNDA for treatment of agitation related to dementia sufficient for review
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.
Amyloid burden similar among those with Alzheimer's disease, Down syndrome
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.
FDA grants accelerated approval for Alzheimer's treatment
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.
Athira Pharma provides 2023 outlook for Alzheimer's, Parkinson’s, ALS trials
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.
Report faults FDA for ‘inappropriately’ working with Biogen on Alzheimer’s treatment
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.