The FDA granted Breakthrough Device Designation to TOBY Inc.'s urine-based Alzheimer's diagnostic test and Instanosis Inc.'s Xylazine Rapid Test (Urine), accelerating development of both non-invasive diagnostic technologies.
A major evidence review of 17 clinical trials involving more than 20,000 participants found anti-amyloid Alzheimer’s drugs had absent or trivial effects on cognitive decline and dementia. The review also said the drugs likely increase the risk of brain swelling and bleeding.
New research reveals significant advances in blood-based biomarkers for Alzheimer's disease, including a pTau 217 assay showing 93% agreement with amyloid PET imaging and identification of interferon gamma as a diagnostic signal linked to genetic risk. These developments address challenges in early diagnosis and monitoring while requiring substantially less plasma than previous tests.
Researchers at Washington University School of Medicine developed a blood test-based method to predict when Alzheimer's symptoms will begin, with accuracy within three to four years, using plasma p-tau217 protein levels.
A single blood test measuring p-tau217 protein can predict when cognitively unimpaired individuals will develop Alzheimer's symptoms, with a margin of error of 3-4 years, potentially accelerating clinical trials.
Researchers at Washington University in St. Louis have adapted CAR-T immunotherapy to target aggregated amyloid-beta in mice, with transient CAR expression clearing brain plaques. The approach uses CD4+ T cells engineered with receptors based on lecanemab antibody sequences.
XingImaging will oversee PET imaging operations for the Alzheimer's Tau Platform Phase II trial, a multi-arm study investigating tau-directed therapies in up to 750 participants across 78 U.S. clinical sites, supported by NIH Grant R01AG078457.
