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Biogen, the co-developer of Aduhelm (aducanumab) has submitted the final protocol for ENVISION — the Phase 4 post-marketing study of the therapy in early Alzheimer’s disease — to the U.S. Food and Drug Administration (FDA) for review and approval, the company has announced. Screening of the first…
Prothena has begun testing single ascending doses (SAD) of PRX012, its investigational anti-amyloid beta antibody therapy, in a Phase 1 clinical trial with healthy volunteers and people with Alzheimer’s disease. This follows the recent approval of the company’s investigational new drug (IND) application for PRX012 by the U.S.
Most adults in the U.S., as well as many doctors, have difficulty distinguishing between the early stages of Alzheimer’s disease and cognitive changes due to normal aging, according to the latest annual report from the Alzheimer’s Association. The report draws on responses to surveys, one of adult Americans…
A dual vaccine targeting both amyloid plaques and tangled fibers made up of tau — two abnormal protein aggregates that build up in the brain of those with Alzheimer’s — may have potential to treat and prevent the disease. Prothena, its developer, has found preclinical evidence that the…
Atuzaginstat (COR388), Cortexyme’s investigational oral therapy, effectively suppressed the activity of its target — toxic enzymes called gingipains — and was associated with reductions in several disease biomarkers in people with mild-to-moderate Alzheimer’s, according to updated data from the Phase 2/3 GAIN clinical trial. Similar to previously reported…
Aduhelm (aducanumab) continues to clear away amyloid plaques and tangled fibers made up of tau — two abnormal protein aggregates that build in the brain of those with Alzheimer’s disease — after nearly two and a half years of treatment, Biogen, which markets the treatment, reports. It also…
AEV103 (3,6’-dithiopomalidomide), a potentially immunomodulating medicine, was able to quell brain inflammation and slow cognitive decline in a mouse model of Alzheimer’s disease, a study has found. The medicine, developed originally at the National Institutes of Health (NIH) and now licensed to AevisBio, exerted its effects even…
The National Institute on Aging has awarded $2.85 million in funding to a research team from the University of Tennessee Health Science Center (UTHSC) to study the role of mitochondria — cells’ powerhouses — in age-related diseases, such as Alzheimer’s. The five-year funding will support a project called…
Seelos Therapeutics is gearing up for a pilot study, in Australia, testing SLS-005 (trehalose) — its investigational therapy for people with Alzheimer’s disease — after receiving an acknowledgment letter from the country’s regulatory body for clinical trials. The letter, from the Australian Government Department of Health Therapeutic Goods…
Eisai has started submitting data to the Japanese Pharmaceuticals and Medical Devices Agency (PMDA) in support of an application for approval of its investigational lecanemab (BAN2401) to treat early Alzheimer’s disease. This submission followed the company’s prior assessment consultation with the PMDA, given in advance of an approval application and intended…
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