Cortexyme has reached a milestone after enrolling 500 patients with mild to moderate Alzheimer’s disease in its ongoing Phase 2/3 GAIN clinical trial testing the company’s investigational treatment COR388 (atuzaginstat). Enrollment for GAIN (NCT03823404) has been open since the second quarter of 2019, with recruitment ongoing at sites in the U.S. and Europe. Data from…
Category: Alzheimer’s
AFA Awards $518K for Study of Neuroimmune Interactions in AD Onset, Progression
The Alzheimer’s Foundation of America (AFA) has awarded $518,391 in research grant funding to the Broad Institute and One Mind to study the role of the brain’s immune cells in the onset and progression of Alzheimer’s disease (AD). The hope is that, with more understanding of immune cells and brain inflammatory processes, scientists can learn…
AC Immune Moves Closer to Clinical Studies of Anti-TDP-43 Antibody
AC Immune is planning to advance its investigational anti-TDP-43 antibody into clinical testing for neurodegenerative diseases in which TPD-43 protein aggregates play a major role in brain damage, including diseases such as Alzheimer’s, amyotrophic lateral sclerosis, and frontotemporal lobar degeneration with TDP-43 pathology. The company began preclinical studies that, if successful, would pave the way…
XPro1595 Lowers Neuroinflammation in Mild to Moderate Alzheimer’s, Interim Results Show
XPro1595, an investigational therapy by INmune Bio, can lower brain inflammation in people with mild to moderate Alzheimer’s disease, according to interim results of a clinical trial. Specifically, the Phase 1b clinical trial (NCT03943264) shows evidence that XPro1595 decreases white matter free water, a biomarker of neuroinflammation measured by magnetic resonance imaging (MRI). XPro1595 was…
Aducanumab Wins FDA Priority Review, Moves Closer to US Approval
The U.S. Food and Drug Administration (FDA) has accepted and given priority review designation to Biogen‘s application requesting the approval of aducanumab (BIIB037) for the treatment of Alzheimer’s disease. While the Prescription Drug User Fee Act (PDUFA) action date is set for March 7, 2021 — meaning a decision is due by then — the agency said it…
Biogen, Eisai Seek FDA Approval of Aducanumab for Alzheimer’s
Biogen and Eisai have submitted a biologics license application (BLA) to the U.S. Food and Drug Administration (FDA) requesting the approval of aducanumab (BIIB037) for the treatment of Alzheimer’s disease. The submission, which was asking for priority review, had been pushed back earlier this year. The agency now has 60 days to decide whether to…
Foundation Offers Free Online Memory Screenings
To promote brain health, the Alzheimer’s Foundation of America (AFA) is offering free online memory screenings that people can participate in from home. The confidential screenings — part of the AFA’s National Memory Screening Program — are provided Mondays and Wednesdays from 10 a.m. to 4 p.m. EST. They are conducted one-on-one through secure videoconferencing.…
AlzeCure Announces Positive Data From Its First Clinical Study of ACD856
AlzeCure Pharma announced positive results from its first clinical study of ACD856 for the potential treatment of Alzheimer’s disease. According to the company, ACD856 showed a good pharmacokinetic profile — namely a significantly shorter human half-life than its predecessor, ACD855 — and suitability for further clinical development as an oral medication for Alzheimer’s. Pharmacokinetics refers,…
Trial of Potential Alzheimer’s Vaccine Advances to Medium Dose Group
Testing of a second and higher dose of ACI-35.030, a potential Alzheimer’s vaccine, is now beginning in a Phase 1b/2a clinical trial, AC Immune announced. Positive interim safety, tolerability, and specificity results from an initial dosing group of patients allowed the trial to advance to its medium dosing regimen, the company reported in a press release. ACI-35.030, being developed…
Flu, Pneumonia Vaccinations Linked to Lower Alzheimer’s Risk
Vaccines against the flu and pneumonia are associated with a lower risk of developing Alzheimer’s disease, while infections are generally linked to increased mortality among people with dementia, according to three research studies presented at this year’s Alzheimer’s Association International Conference, which is being held virtually this week. “With the COVID-19 pandemic, vaccines are at…