AriBio will soon start recruiting participants in the U.K. for the Phase 3 trial of AR1001 (mirodenafil), an investigational oral therapy for early Alzheimer’s disease. This follows a positive opinion of the U.K. Medicines and Healthcare Products Regulatory Agency. The Polaris-AD trial (NCT05531526), which is enrolling patients…
A Phase 3 clinical trial of AVP-786 failed to meet its main goal of easing agitation in adults with dementia due to Alzheimer’s disease, said sponsor Otsuka Pharmaceutical. The clinical trial (NCT03393520), also dubbed 17-AVP-786-305, tested AVP-786’s safety in addition to evaluating its effectiveness compared with a…
The U.S. Food and Drug Administration (FDA) has lifted a clinical hold on a Phase 2 trial testing INmune Bio’s investigational treatment XPro1595 in people with Alzheimer’s disease. Regulators issued the hold in 2022 pending additional manufacturing information from INmune. The company addressed some of the FDA’s…
Health Canada has approved Rexulti (brexpiprazole) for agitation associated with Alzheimer’s disease-related dementia in patients with aggressive behavior. The treatment, co-developed by Otsuka Pharmaceuticals and Lundbeck, was recently approved by the U.S. Food and Drug Administration (FDA) for the same indication. “Today marks a major milestone…
Two Phase 3 clinical trials are testing the effectiveness of simufilam, an experimental oral therapy that’s designed to improve cognition in people with Alzheimer’s disease. Top-line results from the RETHINK-ALZ trial (NCT04994483) are expected by the end of this year,…
Biogen is discontinuing development and commercialization of its controversial Alzheimer’s disease treatment Aduhelm (aducanumab) — a move that’s “not related to any safety or efficacy concerns,” the company said in a press release. Instead, according to Christopher Viehbacher, president and CEO of Biogen, the company is…
A commercially available blood test, sold by ALZpath, can identify with high accuracy Alzheimer’s disease patients who are likely to be eligible for new treatments, a study suggests. By detecting a version of the tau protein in a blood sample, the “ALZpath pTau217 test can help healthcare providers…
The U.S. Food and Drug Administration (FDA) has approved BrainSee, Darmiyan’s software for predicting the likelihood that a person with mild cognitive impairment (MCI) will progress to Alzheimer’s disease-associated dementia. Darmiyan believes the technology will help to screen and identify high-risk patients early, enabling a prompt start…
Enrollment is now complete in the LIFT-AD clinical trial evaluating Athira Pharma‘s fosgonimeton, an experimental treatment for mild-to-moderate Alzheimer’s disease. The Phase 2/3 study (NCT04488419) enrolled about 315 participants, who received either 40 mg fosgonimeton or a placebo for 26 weeks (about six months). Top-line data is expected in…
A tool called focused ultrasound, or FUS, may be a safe and promising way to help antibody-based treatments better reach the brain, and clear away toxic amyloid-beta protein clumps (aggregates), in people with Alzheimer’s disease. The approach involves using targeted sound waves to temporarily open up the selective blood-brain…
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