The first patient has been dosed in the resumed Phase 2a clinical trial of montelukast for mild to moderate Alzheimer’s disease. IntelGenx, the company running the study known as BUENA (NCT03402503), suspended the trial in late 2020 due to increased concern regarding the COVID-19 pandemic. “Resumption of patient dosing after a COVID-related interruption of the…
Conditions
Conditions
First Patient Joins Tau NexGen Study in Early-onset Alzheimer’s
A first patient has joined the Tau NexGen study that will test two antibodies in combination — targeting both amyloid and tau proteins — as a potential treatment for early-onset Alzheimer’s disease caused by genetic mutations, according to a press release. Tau NexGen is a newly added arm of a Phase 2/3 platform trial, called…
Riney Foundation’s $40M Gift to Further Research at Dana-Farber
The Paula and Rodger Riney Foundation continues to support the Dana-Farber Cancer Institute in its efforts to advance multiple myeloma research, this time with a $40 million grant. This gift — the largest single award to myeloma research in Dana-Farber’s history — brings the foundation’s donations to the institute to nearly $60 million. “The path to…
Aduhelm Phase 4 ENVISION Study to Increase Participant Diversity
Up to 18% of U.S. participants in ENVISION — a Phase 4 post-marketing study of Aduhelm (aducanumab) in early Alzheimer’s disease — will now be enrolled from African American and Latinx populations, the therapy’s developers said in a press release. The aim is to increase diversity in the trial, which seeks to confirm the impact of…
Dosing Begins in Trial of CY6463 for Patients With Cardiovascular Risk
Patient dosing has begun in Cyclerion Therapeutic’s Phase 2a trial testing CY6463, a disease-modifying therapy for people with Alzheimer’s disease who have cardiovascular risk factors — health conditions that increase the risk of heart disease. The experimental oral therapy is designed to improve cognition and function in people with Alzheimer’s. “We believe that CY6463 has potential…
FDA Puts Full Hold on Clinical Testing of Cortexyme’s COR388
The U.S. Food and Drug Administration (FDA) has placed a full clinical hold on COR388 (atuzaginstat), an investigational oral therapy Cortexyme is developing for Alzheimer’s disease and now cancer. The decision means that Cortexyme will not be allowed to conduct in-person testing of COR388 until further notice. The company will provide further updates pending additional communication…
Immune Therapy AO-176 Awarded FDA’s Orphan Drug Designation
The U.S. Food and Drug Administration (FDA) has granted orphan drug status to Arch Oncology‘s experimental immune-modulating therapy AO-176 as a potential treatment for relapsed or refractory multiple myeloma. This designation, given to therapies with the potential to improve care for conditions that affect fewer than 200,000 people in the U.S., qualifies Arch, as the…
Plan to Limit Medicare Coverage of Aduhelm Called ‘Not Patient-centered’
A recent proposal that Medicare only cover Aduhelm (aducanumab) for patients with Alzheimer’s disease who are enrolled in clinical trials is needlessly restrictive, and will prevent many people from accessing a medication that may be able to help them. That’s the argument made by Jeffrey Cummings, MD, a professor of brain health at the University…
Optimized Amyloid-targeting Vaccine ACI-24 Shows Promise in Animal Studies
An optimized version of ACI-24, an experimental vaccine designed to induce an immune response against abnormal protein clumps that drive Alzheimer’s disease, was able to induce a powerful immune response — as intended — and generally was well-tolerated in animal studies. Scientists at AC Immune, which is developing ACI-24, published the findings in Brain Communications,…
UsAgainstAlzheimer’s, Experts Blast Medicare’s Plan for Aduhelm
A recent proposal to limit Medicare coverage for Aduhelm (aducanumab) and similar medicines to Alzheimer’s disease patients who are enrolled in clinical trials ignores current science and would drastically curtail access these therapies, UsAgainstAlzheimer’s argues. UsAgainstAlzheimer’s (UsA2), based in Washington, D.C., is founded by family members of people affecting by Alzheimer’s. Its comment letter was in response to…
Xpovio-Kyprolis Combo Shows Good Response in Hard-to-treat Myeloma
Xpovio (selinexor) combined with Kyprolis (carfilzomib) and low-dose dexamethasone leads to strong and durable responses in heavily pretreated multiple myeloma patients, results from a Phase 1/2b trial show. The study, “Once weekly selinexor, carfilzomib and dexamethasone in carfilzomib non-refractory multiple myeloma patients,” was published in the British Journal of Cancer. Xpovio, developed by Karyopharm Therapeutics, is…
Blood From Active Mice Appears to Benefit Brains of Sedentary Peers
Blood from “runner” mice can boost cognition and memory, and lessen brain inflammation — a key feature seen in people with neurodegenerative diseases, such as Alzheimer’s — when transferred into sedentary mice, a study shows. The benefits of “exercised” blood was linked to high levels of the clusterin protein, an inhibitor of the complement signaling…