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…
About Alzheimer’s Disease
Walking into a room and forgetting why you went into the room is normal. Walking into a room and forgetting what room you are in is not normal. Alzheimer’s disease is the most common form of dementia and affects one in ten people over the age of 65. Unfortunately, the exact cause of Alzheimer’s disease is not fully understood however leading scientific experts in the field attribute the illness to the irreversible and progressive generalized degeneration of the brain. Alzheimer’s disease goes well beyond the forgetfulness that may accompany aging, and typically first signs include difficulty remembering current information or performing new tasks. Ongoing hallmark symptoms include impaired memory function, difficulty performing everyday tasks, and neurobehavioral abnormalities. Currently, there is no known cure for Alzheimer’s disease, and multi-disciplinary treatment focuses on symptom management and limiting progression.
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Alzheimer’s News
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…
Rethink-ALZ.com, New Website on Simufilam Phase 3 Studies, Is Live
Cassava Sciences has launched a new website, called Rethink-ALZ.com, to make it easier for anyone interested to access information about two Phase 3 clinical studies of simufilam, the company’s oral investigational therapy for mild-to-moderate Alzheimer’s disease. The trials, dubbed RETHINK-ALZ and REFOCUS-ALZ, are ongoing in the U.S. and Canada, and both are currently recruiting patients with…
Proposal That Medicare Covers Aduhelm Only for Trials Sparks Outrage
A new proposal in the U.S. that Medicare cover the cost of Aduhelm (aducanumab) only for people enrolled in qualifying clinical trials has been met with outrage from the Alzheimer’s Association and decried by Biogen, which developed the treatment alongside Eisai. Issued by the U.S. Centers for Medicare and Medicaid Services (CMS), the proposed National…
Clinical Trial Set for Gantenerumab in Early-onset Alzheimer’s Disease
An international clinical trial for gantenerumab aimed at preventing inherited, early-onset Alzheimer’s disease is being launched at the Washington University School of Medicine in St. Louis. The trial, called the Primary Prevention Trial, is enrolling people with a family history of early-onset Alzheimer’s and its associated genetic mutations up to 25 years before their expected onset…
Alzheimer Society of Canada Programs Are ‘First Link’ of Support
To ensure that dementia patients and their caregivers have proper support and information, the Alzheimer Society of Canada is calling attention to its First Link program, designed to share a key message: “You are not alone.” The Canada-wide campaign, announced in January during the country’s Alzheimer’s Awareness Month, seeks to remind those with dementia or…
FDA Approval Again Wanted for Nuplazid in Easing Psychosis
Acadia Pharmaceuticals intends to again request that oral Nuplazid (pimavanserin) be approved to treat hallucinations and delusions, but this time only when associated with the dementia-related psychosis of Alzheimer’s disease. Its planned request to the U.S. Food and Drug Administration (FDA), in the form of a resubmitted supplemental new drug application (sNDA), follows the FDA’s rejection last year of…
Lecanemab for Early Alzheimer’s Granted the FDA’s Fast Track Status
Lecanemab, an investigational antibody also known as BAN2401, has been granted a fast track designation from the U.S. Food and Drug Administration (FDA), which may help speed up its development for the treatment of early Alzheimer’s disease. The antibody, developed jointly by Biogen and Eisai, is designed to bind to the protein amyloid-beta. This potentially…
Top 10 Alzheimer’s Disease Stories of 2021
Alzheimer’s News Today brought you coverage of the latest scientific advances, developments in treatment, and clinical trials related to Alzheimer’s disease throughout 2021. We look forward to continuing to report important news for the Alzheimer’s community this year. Here are the top 10 most-read Alzheimer’s stories of 2021. No. 10 – “1st Phase 3 Simufilam Trial…
Alzheimer’s Association Welcomes Aduhelm Price Cut, But Presses On
While calling the recent decision to slash by about half the U.S. list price for Aduhelm (aducanumab) an “important step,” the Alzheimer’s Association continues to advocate for more equitable access to the first new Alzheimer’s therapy since 2003. Specifically, the organization is calling for Biogen, which with Eisai developed and markets Aduhelm, to extend support to early-stage patients whose…
Aduhelm Developers Step Up Phase 4 Confirmatory Study
Biogen and Eisai are stepping up their Phase 4 post-marketing confirmatory study to verify that Aduhelm (aducanumab) is meeting the expected clinical benefit in patients with early-stage Alzheimer’s disease. The companies plan to submit the study’s final protocol for review to the U.S. Food and Drug Administration (FDA) in March. The study will be aiming to…
ANVS401 Lessens Protein Buildup, Improves Cognition, Data Show
Annovis Bio’s oral therapy ANVS401 lessened the accumulation of toxic forms of amyloid-beta and tau protein — two hallmarks of Alzheimer’s disease — and led to significant improvements in cognition in patients with early Alzheimer’s, data from a Phase 2a study show. Moreover, ANVS401 levels in the blood were in agreement with previous studies and the…