The FDA has cleared an IND application for ADEL-Y01, being jointly developed by Oscotec Inc. and Adel Inc., for the treatment of Alzheimer’s disease. A phase Ia/b study will include healthy volunteers, and participants with mild cognitive impairment due to Alzheimer’s disease or mild Alzheimer’s disease.
Alzheimer’s disease (AD) has a new candidate for its treatment. Nasal anti-CD3 monoclonal antibody (MAb) reduced microglia activation in the brain of mice without its effect being dependent on the β-amyloid (Aβ) deposits characteristic of this neurodegenerative disorder. “We have done many basic studies in the laboratory on microglia. Microglia activation occurs in many neurologic diseases. One of them is multiple sclerosis (MS). And it also occurs in AD,” senior author Howard Weiner told BioWorld.
The first special purpose acquisition company (SPAC) merger announced in 2023 has fallen apart. Aprinoia Therapeutics Inc. and Ross Acquisition Corp. II mutually agreed to call off the merger that had been valued at $280 million. The failed deal is part of a larger trend that has gained momentum in the past year as a struggling economy and tighter U.S. SEC restrictions dampened SPAC deals.
Imeka Solutions Inc. has received U.S. FDA 510(k) clearance for the Advanced Neuro Diagnostic Imaging system designed to provide neurologists and radiologists with vital reference information on cerebral white matter for better management of brain diseases such as Alzheimer’s. This comes on the heels of two new CPT 3 codes for quantitative brain MRI assessment which Imeka expects its clients will begin taking advantage of by January 2024.
Investigators have functionally linked the Alzheimer’s disease (AD) risk gene SORL1 to apolipoprotein E (ApoE) and clusterin, another apolipoprotein. The work, Tracy Young-Pearse told BioWorld, is part of an attempt to “try to understand different subtypes of Alzheimer’s disease.” It maps some of what Young-Pearse termed the “many molecular roads that lead to Alzheimer’s” – which, in turn, is the first step to setting up roadblocks. Young-Pearse is an associate professor in the Ann Romney Center for Neurologic Diseases at Brigham and Women’s Hospital and Harvard Medical School and co-leader of the Harvard Stem Cell Institute’s Nervous System Diseases Program. She is also the senior author of the paper describing the findings, which appeared online in Cell Reports on Aug. 22, 2023.
17-β-hydroxysteroid dehydrogenase type 10 (17-β-HSD10) catalyzes the turnover of steroids and neurosteroids, among other substrates, and is also a structural component of RNase P. 17-β-HSD10 is involved in the development of several pathologies, and considered a potential drug target for Alzheimer’s disease and some hormone-dependent cancers. A few 17-β-HSD10 inhibitors with either pyrazole, steroids, or benzothiazolylurea structure have been previously developed.
The U.S. Centers for Medicare & Medicaid Services has proposed to terminate the coverage with evidence development requirement for the use of positron-emission tomography (PET) imaging for patients suspected of suffering from beta amyloids, a marker of Alzheimer’s disease (AD). However, CMS is also considering a removal of the coverage policy that limits each patient to a single PET scan per lifetime, although the proposal to allow Medicare administrative contractors (MACs) to determine coverage is drawing fire from industry and physician groups alike.
The role of the enzyme γ-secretase in neuronal cholesterol metabolism could have a beneficial effect on the synapse that has not yet been explored in Alzheimer’s disease (AD). On Aug. 4, 2023, scientists at Stanford University School of Medicine and the Howard Hughes Medical Institute published a study online in Neuron that linked cholesterol levels in the brain to synaptic dysfunction in AD.
With more drugs for Alzheimer’s disease (AD) gaining FDA approval and an aging population at increased risk of dementia, the need for AD diagnostics is only going to grow. An estimated 6.7 million Americans live with Alzheimer’s today, with that number projected to hit 14 million by 2060, according to the CDC.
Protein quality control research is “almost exclusively focused on heat shock proteins, which are ubiquitously present” up and down the evolutionary chain, Xiaolu Yang told BioWorld. But “for more sophisticated organisms, which we humans like to think we are, it’s a little odd that we still use the system that bacteria started with…. It seems like we should have something more. The TRIM system,” he added, “fills that gap.”
