A standardized MRI protocol to screen for brain imaging abnormalities in people with Alzheimer’s who are being treated with Aduhelm in a large observational study was described in a presentation at the 2022 American Academy of Neurology (AAN) annual meeting. “Consistency in MRI acquisition is important for efficient and treatment and to overcome [variation] in…
Conditions
Conditions
#AAN2022 – Real-world Trial of Aduhelm Now Enrolling Patients in US
Biogen is continuing to actively recruit Alzheimer’s patients for its Phase 4 ICARE AD-US trial, which is evaluating the long-term safety and effectiveness of Aduhelm (aducanumab) in the real-world U.S. clinical setting. Participants — including a targeted enrollment of 16% Latino and African American patients — are currently being enrolled at more than 10 sites in…
Organizations Rally to Help Ukrainian Rare Disease Patients
A Russian military plane crash near Tetiana Zamorska’s home in Kyiv, Ukraine, was a sign that it was time for her and her family to leave. The treacherous, 34-hour pilgrimage that ultimately brought the group of eight by car to temporary accommodations in neighboring Poland last month was physically and emotionally difficult, Zamorska recently told BioNews, Inc.,…
#AAN2022 – Allopregnanolone Found Safe, May Ease Brain Atrophy
The therapeutic candidate allopregnanolone is safe and well-tolerated in people with early Alzheimer’s disease, according to data from a Phase 1b/2a clinical trial that also investigated the medication’s maximum-tolerated dose. Moreover, MRI scans showed that allopregnanolone — dubbed ALLO by researchers — may protect against brain tissue loss in these patients. “Allopregnanolone was well-tolerated and…
Miami VA Clinical Site Joins Phase 2 Lomecel-B Clinical Trial
A Miami Veterans Affairs (VA) clinical site is now part of Longeveron’s Phase 2a clinical trial testing Lomecel-B — an investigational, bone marrow-derived, medicinal signaling cell (MSC) treatment — in patients with mild Alzheimer’s disease. The new clinical site was added following a Cooperative Research and Development Agreement (CRADA) with the U.S. Department of Veterans…
Agreement Reached to Develop MMP-13 Inhibitors to Treat Myeloma
SteroTherapeutics has entered into an exclusive license agreement with Moffitt Cancer Center and Florida Atlantic University Research Corporation to develop matrix metalloproteinase 13 (MMP-13) inhibitors for treating multiple myeloma. “This partnership with Moffitt Cancer Center and the Research Institute of Florida Atlantic University will allow us to further develop this novel line of highly selective MMP-13…
‘Good’ Cholesterol in Brain May Aid Cognition, Help Prevent Alzheimer’s
Higher levels of small high-density lipoprotein (HDL), known as “good cholesterol,” in the fluid surrounding the brain and spinal cord associated with a better performance on cognitive tests in older adults, a study reported. Confirmation of a link between good cholesterol levels and cognitive outcomes in larger groups could lead to new biomarkers of Alzheimer’s disease and…
Biogen Scraps Infrastructure for Aduhelm Sales in US
Biogen is eliminating corporate infrastructure that had been put in place to support sales of Aduhelm (aducanumab) in the U.S., the company announced. The decision is being made in response to a policy announced last month that Medicare would only cover the cost of Aduhelm for people with Alzheimer’s disease enrolled in select clinical trials.…
FDA Committee to Review Nuplazid in Treating Alzheimer’s Psychosis
A U.S. Food and Drug Administration (FDA) advisory committee will host a virtual meeting to review a request to expand the approval of Nuplazid (pimavanserin) to include psychosis due to Alzheimer’s disease dementia. The FDA’s Psychopharmacologic Drugs Advisory committee meeting on the application recently submitted by Acadia Pharmaceuticals, which developed and markets Nuplazid, is scheduled for June 17. The committee’s decision…
Ninlaro as Oral Combo Therapy Fails at Trial in Heavily Treated Patients
Adding Ninlaro (ixazomib) to cyclophosphamide and dexamethasone does not improve progression-free survival for multiple myeloma patients who relapsed after several lines of treatment, a Phase 2 trial reported. The study, “Ixazomib with cyclophosphamide and dexamethasone in relapsed or refractory myeloma: MUKeight phase II randomised controlled trial results,” was published in the journal Blood Cancer Journal.…
Treatment Lowers Toxic Amyloid-beta Levels in Mouse Brain Cells
An investigational gamma-secretase modulator designed for the treatment of Alzheimer’s disease led to an efficient and long-lasting reduction of toxic amyloid-beta 42 peptide in cell cultures and mouse brain cells, according to data from a recent study. In mice, the compound, called AC-0027875, was also able to penetrate the brain in high concentrations, which is…
Eisai Completes Rolling Submission to FDA for Lecanemab Approval
Eisai has completed a rolling submission to the U.S. Food and Drug Administration (FDA) to seek approval for lecanemab (BAN2401), an investigational antibody for the treatment of early Alzheimer’s disease accompanied by beta-amyloid deposits in the brain. The request — made in the form of a biologics license application (BLA) — if accepted by the…