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…
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
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.…
‘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…
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…
#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…
#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…
#AAN2022 – MRI Protocol to Monitor for ARIA With Aduhelm’s Use Detailed
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…
Biogen Withdraws Application Seeking Approval of Aduhelm in EU
Biogen has withdrawn its application seeking approval of Aduhelm (aducanumab) to treat early Alzheimer’s disease in the European Union. A committee of the European Medicines Agency (EMA) recommended against approving Aduhelm late last year. Biogen had requested a re-examination of that decision, made by the Committee for Medicinal Products for Human Use (CHMP), but now the…
Dosing Begins in Phase 2 Trial of XPro1595, Targeting Inflammation
A first patient has been dosed in a Phase 2 trial of XPro1595, INmune Bio’s candidate therapy for Alzheimer’s disease. The MINDFuL trial (NCT05318976) aims to recruit around 201 people, ages 60–85, with mild Alzheimer’s and biomarkers of brain inflammation across multiple sites in the U.S., Australia, and Canada. Top-line results are expected in 2023. For…
Clinical Trials Show Promise For Araclon’s Vaccine, Diagnostic Test
ABvac40, an investigational vaccine, was safe and led to antibodies forming against the toxic amyloid-beta 40 peptide in people with Alzheimer’s disease, according to data from a Phase 2 trial. ABvac40’s developer, Araclon Biotech, has also made progress in developing a blood test to detect Alzheimer’s in its early stages, Araclon’s lead shareholder, Grifols, reported…
CogniCann, Potential Cannabinoid Therapy, Being Prepared for Europe
Sciensus Rare, a Dutch healthcare group, was given rights to distribute CogniCann, MGC Pharmaceutical’s cannabinoid-based investigative treatment for people with dementia and Alzheimer’s disease in Europe, should it be approved for commercial use or use in select early access programs. The agreement stipulates that Sciensus Rare will have four years of exclusive distribution rights for CogniCann in…
STAR Molecule Shows Promise in Cell Model of Alzheimer’s Disease
Gain Therapeutics‘ investigational STAR (small-molecule structurally targeted allosteric regulators) candidate lowered toxic amyloid-beta and tau protein levels, both hallmarks of Alzheimer’s disease, in a cellular model of the disease. Treatment with the STAR molecule enhanced the survival and boosted communication between nerve cells, the company announced. The results support the potential of STARs molecules for…