Novel Therapy for Alzheimer Disease Agitation Gets Breakthrough Designation
The FDA has granted Breakthrough Therapy designation to AXS-05 (Axsome Therapeutics) for the treatment of Alzheimer disease (AD) agitation.
Alzheimer Disease and Dementia
Anticholinergic Meds for Overactive Bladder May Up Dementia Risk
Among patients with overactive bladder (OAB), anticholinergic medication use appears to be associated with an increased risk of new onset dementia when compared with beta-3 agonist use, according to the findings of a retrospective population-based cohort study.
Gene Therapy for Frontotemporal Dementia With a GRN Mutation Gets Fast Track Status
The FDA has granted Fast Track designation to PR006 (Prevail Therapeutics), an experimental gene therapy, to slow the progression of frontotemporal dementia with a GRN mutation.
Belsomra Labeling Updated to Include Data on Insomnia in Alzheimer Disease
The Food and Drug Administration (FDA) has approved updates to the prescribing information for Belsomra® (suvorexant; Merck) to include study findings for the treatment of insomnia in patients with mild to moderate Alzheimer disease.
FDA to Review Donepezil Transdermal System for Alzheimer Disease
A PDUFA target date of June 30, 2020 has been assigned to the application.
More Hospital Days Seen With Antipsychotic Use in Alzheimer Disease
Number of hospital days up by more than 50 percent in AD patients initiating antipsychotic medication
Neflamapimod Gets Fast Track Status for Dementia With Lewy Bodies
The FDA has granted Fast Track designation to neflamapimod (EIP Pharma) for the treatment of dementia with Lewy bodies (DLB).
MPR Weekly Dose Podcast: Episode 10
This week we talk about the resurrection of Biogen’s novel Alzheimer treatment; A “landmark” approval in cystic fibrosis; Expanded indication for Farxiga; The first topical minocycline formulation for acne vulgaris; and the Johnson & Johnson baby powder recall.
Aducanumab BLA to Be Submitted Following Positive Results in Early Alzheimer Trial
Compared with placebo, high dose aducanumab was associated with significant reduction of clinical decline in patients with early Alzheimer disease, as measured by the change from baseline in Clinical Dementia Rating-Sum of Boxes score at 78 weeks.
Nonpharmacologic Interventions Reduce Agitation in Dementia
Nonpharmacologic more efficacious than pharmacologic interventions for reducing aggression, agitation
