Athira Pharma has begun dosing patients in its Phase 2 clinical trial evaluating ATH-1017, an investigational small molecule for the treatment of mild to moderate Alzheimer’s disease. Clinical efficacy will be demonstrated by improvements in cognition and functional assessments among participants, compared with a placebo. “The initiation of our second late-stage study for ATH-1017 represents…
Category: Alzheimer’s
Cortexyme’s COR388 GAIN Trial Advances to Endpoint; Results Expected Late 2021
Cortexyme’s ongoing Phase 2/3 GAIN clinical trial, which is evaluating the investigational treatment COR388 (atuzaginstat) in people with mild to moderate Alzheimer’s disease, has been approved to continue as planned to its one-year endpoint, the company said. Topline results from the study, testing whether COR388 can lessen dementia and neurodegeneration in Alzheimer’s, are expected on time…
Last Patient Finishes ALZT-OP1 Combo Therapy Trial; Results Expected Early 2021
The last participant has completed all predefined assessments in the Phase 3 COGNITE clinical trial, which is assessing the safety and effectiveness of AZTherapies’ treatment candidate ALZT-OP1 for people with early Alzheimer’s disease. The trial’s top-line results are expected in the first months of 2021. The biopharmaceutical company hopes its investigational therapy will be found…
Social Inequalities Found in US Counties With Highest Alzheimer’s Rates Among Blacks, Latinos
A recent report found deep social inequalities in U.S. counties with the highest Alzheimer’s rates among Blacks and Latinos. Inequalities related to education, income, food insecurity, and the physical environment are collectively known as social determinants of health and are inextricably tied to location, according to the report from UsAgainstAlzheimer’s Center for Brain Health Equity…
IGC Starts Phase 1 Study of Low-dose Cannabinoid in Alzheimer’s Patients
A Phase 1 trial is enrolling patients with mild to severe dementia from Alzheimer’s disease to test IGC-AD1, an investigational cannabis-based treatment being developed India Globalization Capital (IGC) Pharma, a subsidiary of IGC, according to a recent press release. In the placebo-controlled study, 12 participants will receive the medication over three 14-day periods, with the…
AlzeCure’s Lead Therapy Candidate Entering Phase 1 Testing in Sweden
AlzeCure Pharma is preparing to launch a Phase 1 clinical trial in Sweden to evaluate the tolerability and safety of ACD856, one of its therapy candidates for Alzheimer’s disease, the company announced. The trial follows the release of the first positive clinical results, in which ACD856 showed a good pharmacokinetic profile (how the body affects…
Gum Disease Bacteria Found in Most Alzheimer’s Patients in Atuzaginstat Trial
Most of the mild to moderate Alzheimer’s patients enrolled in the atuzaginstat (COR388) Phase 2/3 trial show evidence of systemic infection due to Porphyromonas gingivalis, a bacteria linked to periodontal disease whose toxic enzymes are thought to contribute to Alzheimer’s and are targets for this candidate therapy. A “high proportion” also test positive for biomarkers associated with this neurodegenerative disease.…
Last Participant Finishes PEGASUS Clinical Trial, Results Expected Next Year
The last participant has completed the planned 24 weeks in the Phase 2 PEGASUS clinical trial, which is assessing the safety and biological activity of Amylyx Pharmaceuticals‘ investigational therapy AMX0035 in people with Alzheimer’s disease. Top-line results from the trial are expected in the first half of 2021. “The PEGASUS trial design and broad inclusion…
FDA Clears Neuraly to Begin Phase 2 Trial of NLY01 in Alzheimer’s Patients
The U.S. Food and Drug Administration has given clearance for a Phase 2B clinical trial to evaluate the safety, tolerability, and efficacy of Nueraly‘s investigational therapy NLY01 in people with Alzheimer’s disease. The randomized, double-blinded, placebo-controlled trial is expected to enroll more than 500 people with mild cognitive impairment due to Alzheimer’s disease at more…
FDA Committee Votes Do Not Support Aducanumab as Effective Treatment
An advisory arm of the U.S. Food and Drug Administration (FDA) is recommending that available clinical data on aducanumab (BIIB037) does not support the effectiveness of this investigational therapy in treating Alzheimer’s disease. In votes, eight of the committee’s 11 members found Phase 3 EMERGE data did not provide “strong evidence” of efficacy, and seven members…