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…
Author: Chris
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…
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…
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…
First Patient Dosed in Resumed Trial of Montelukast for Alzheimer’s
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…
NIH $2M Grant Supports Work Into Chronic Stress and Alzheimer’s
The National Institutes of Health (NIH) awarded $2 million to investigators studying how chronic physiological stress may cause vascular changes and exacerbate the cognitive decline seen in Alzheimer’s disease. Paul Chantler, PhD, an associate professor at West Virginia University School of Medicine, and his team are also using animal models to investigate how xanthine oxidase…
Japan OKs Abecma as 1st CAR T-cell for Heavily Treated Myeloma
Japan’s Ministry of Health, Labour, and Welfare has approved Abecma (idecabtagene vicleucel) as its first CAR T-cell therapy for adults with relapsed or refractory multiple myeloma who received at least three prior therapies. This includes patients treated at least with one immunomodulatory drug (IMiD), one proteasome inhibitor (PI), and one CD38 inhibitor, and whose disease failed to…
Stroke Therapy Candidate 3K3A-APC Holds Promise for Dementia
3K3A-APC, an investigational therapy for stroke about to enter Phase 3 clinical testing, may also help to protect the brain against Alzheimer’s disease and other forms of dementia. “Our recent and current data support development of 3K3A-APC for neurological conditions associated with cognitive dysfunction such as Alzheimer’s disease and injury to the brain’s white matter…
FDA Puts Hold on Plans to Start Clinical Testing of DNL919 Therapy
The U.S. Food and Drug Administration (FDA) has put a clinical hold Denali Therapeutics’ application to begin clinical testing of DNL919, an immune-modulating medication that the company is developing to treat Alzheimer’s disease. The FDA will issue an official clinical hold letter to Denali in the next month or so, according to a company press…
Phase 2a Trial Initiated for Lomecel-B in Mild Alzheimer’s Disease
Longeveron is initiating a Phase 2a clinical trial for its Lomecel-B treatment — an investigational, bone marrow-derived, medicinal signaling cell (MSC) — in patients with mild Alzheimer’s disease. The first patient has already given consent to participate in the trial, and further patient screening has begun. “We are pleased to have initiated this Phase 2a…