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…
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…
A first patient has been dosed in a Phase 2 trial evaluating the effects of ALZ-801 on disease-related biomarkers in people with early Alzheimer’s disease, who have a specific genetic variant associated with an increased risk of disease progression. “This biomarker study is a key element of our…
Note: This story was updated Oct. 12, 2020, to note that semorinemab is intended to target phosphorylated and non-phosphorylated forms of tau. Semorinemab, a monoclonal antibody against tau, failed to significantly alter dementia’s progression in people with early Alzheimer’s disease (AD) taking part in a Phase 2 clinical…
Axsome Therapeutics announced plan to soon open a Phase 3 clinical trial of AXS-05, its investigational oral treatment for Alzheimer’s disease-related agitation, after U.S. Food and Drug Administration (FDA) officials confirmed an earlier study was pivotal. Results from this new efficacy trial, to open before year’s end,…
People in Australia with Alzheimer’s disease who have finished five years of treatment with Anavex 2-73 (blarcamesine) in Phase 2 clinical trials may continue to use Anavex Life Sciences‘ investigational oral therapy at their doctor’s request. Under a special access scheme, the Therapeutic Goods Administration (TGA) — a…
A type of mouth bacteria involved in gum disease is able to infect human brain cells, new research shows. The infection results in cellular changes that are similar to what is seen in Alzheimer’s, supporting a link between the bacteria and the neurodegenerative disease. The findings were presented at…
Cassava Sciences‘s investigational therapy PTI-125 failed to significantly lower the levels of Alzheimer’s-relevant biomarkers present in fluid surrounding the brain and spinal cord of patients, according to results from a Phase 2b clinical trial. The company announced it will study these topline data in deciding next…
Taking daily low-dose aspirin does not seem to reduce the risk of dementia, cognitive decline, or Alzheimer’s disease, new clinical trial data show. The results were published in Neurology in a study, titled “Randomized placebo-controlled trial of the effects of aspirin on dementia and cognitive decline.”…
Axsome Therapeutics is planning to complete its ADVANCE-1 clinical trial, evaluating AXS-05 as a treatment for agitation in Alzheimer’s disease, a few months earlier to ensure the safety of study participants during the COVID-19 pandemic. Top-line results from this Phase 2/3 trial, which opened in 2017, are now expected…
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