The U.S. Food and Drug Administration (FDA) has accepted a request by Acadia Pharmaceuticals‘ that Nuplazid (pimavanserin) be approved for a new indication: the treatment of delusions and hallucinations associated with dementia-related psychosis. The company’s supplemental new drug application, which was submitted in June, was granted standard review status. The FDA’s decision is expected by April…
BAN2401, an experimental treatment for Alzheimer’s disease (AD), will be tested in the new global AHEAD 3-45 clinical trial, its developers have announced. The Phase 3 study — to be conducted in the U.S., Canada, Japan, Australia, Singapore, and Europe — will test the therapy in people who are in the early stage of the…
The Alzheimer’s Foundation of America (AFA) is expanding the availability of its National Toll-Free Helpline — adding weekend hours as well as chat and message features in dozens of languages — to provide greater support to patients and family members. The resource’s hours now are 9 a.m. to 9 p.m. EST on weekdays, and 9…
Amylyx Pharmaceuticals announced it has completed enrollment for the Phase 2 clinical trial of AMX0035 for treating Alzheimer’s disease. The placebo-controlled trial, PEGASUS (NCT03533257), will evaluate the compound’s safety and tolerability among patients with late mild cognitive impairment or early dementia due to Alzheimer’s disease. Other study endpoints (goals) include the compound’s effects on Alzheimer’s biomarkers (methods…
The U.S. Food and Drug Administration (FDA) has granted breakthrough therapy designation to Axsome Therapeutics‘ AXS-05, an investigational oral therapy for the treatment of agitation in people with Alzheimer’s disease. This designation is intended to accelerate the development and review of potential therapies for serious diseases. It is awarded upon clinical evidence of substantial improvement…
Scientists used a new imaging technique to assess the structure of amyloid-beta aggregates — known culprits in Alzheimer’s development — that are present inside nerve cells at early stages of the disease, a study reports. These findings, from a mouse model, may be important to understanding the different stages of Alzheimer’s progression. The study, “Super‐Resolution Infrared Imaging of…
Experiments on the International Space Station showed gravity affects the formation of amyloids, the pathological tangles of proteins found in the brains of those with Alzheimer’s disease. Both the speed by which they formed and the structure they took in microgravity differed from amyloids formed through similar means in an Earth-bound lab, the scientists reported,…
Anavex Life Sciences will expand its Phase 2b/3 clinical trial testing the efficacy and safety of Anavex 2-73 (blarcamesine) for the treatment of early Alzheimer’s disease into Canada and the United Kingdom (U.K.) following the go-ahead from Health Canada and the U.K.’s Medicines and Healthcare products Regulatory Agency (MHRA). The clinical trial, dubbed Anavex 2-73-AD-004…
Neurotrope has announced the launch of a Phase 2 clinical trial to investigate the long-term use of bryostatin-1 for moderate and moderately severe Alzheimer’s disease. The company expects to dose the first patient later this year. “We are very excited to advance Bryostatin-1 to its next phase of development,” Daniel Alkon, MD, president and chief…
“The Longest Day” is the summer solstice — the day with the most light — which falls this year on June 20. It’s also the day each year that people all over world battle “the darkness of Alzheimer’s” through fundraising for the Alzheimer’s Association (AA). All proceeds raised in the annual daylong fundraiser go to…
