A first patient has been dosed in a Phase 2 trial of XPro1595, INmune Bio’s candidate therapy for Alzheimer’s disease. The MINDFuL trial (NCT05318976) aims to recruit around 201 people, ages 60–85, with mild Alzheimer’s and biomarkers of brain inflammation across multiple sites in the U.S., Australia, and Canada. Top-line results are expected in 2023. For…
Category: Alzheimer’s
Clinical Trials Show Promise For Araclon’s Vaccine, Diagnostic Test
ABvac40, an investigational vaccine, was safe and led to antibodies forming against the toxic amyloid-beta 40 peptide in people with Alzheimer’s disease, according to data from a Phase 2 trial. ABvac40’s developer, Araclon Biotech, has also made progress in developing a blood test to detect Alzheimer’s in its early stages, Araclon’s lead shareholder, Grifols, reported…
CogniCann, Potential Cannabinoid Therapy, Being Prepared for Europe
Sciensus Rare, a Dutch healthcare group, was given rights to distribute CogniCann, MGC Pharmaceutical’s cannabinoid-based investigative treatment for people with dementia and Alzheimer’s disease in Europe, should it be approved for commercial use or use in select early access programs. The agreement stipulates that Sciensus Rare will have four years of exclusive distribution rights for CogniCann in…
STAR Molecule Shows Promise in Cell Model of Alzheimer’s Disease
Gain Therapeutics‘ investigational STAR (small-molecule structurally targeted allosteric regulators) candidate lowered toxic amyloid-beta and tau protein levels, both hallmarks of Alzheimer’s disease, in a cellular model of the disease. Treatment with the STAR molecule enhanced the survival and boosted communication between nerve cells, the company announced. The results support the potential of STARs molecules for…
Eisai, Geisinger to Test If AI Tool Can Identify Early Dementia Risk
Eisai has partnered with Geisinger to assess whether a machine-learning model can accurately identify people with cognitive impairment — which may suggest early signs of dementia. Machine learning is a form of artificial intelligence (AI) that uses algorithms to analyze data, learn from its analyses, and then make a prediction. The AI tool will be…
NNI-362 Is Safe, Lowers Alzheimer’s Biomarker in Older, Healthy Adults
NNI-362, Neuronascent’s investigational treatment for Alzheimer’s disease, was safe and reduced blood levels of an Alzheimer’s biomarker in a Phase 1a trial of the therapy in healthy, older adults. The primary goal of the trial (NCT04074837), which enrolled 56 adults between the ages of 50 and 72, was to determine the safety and tolerability of…
Medicare Coverage of Aduhelm Will Be Limited to Patients in Trials
The Centers for Medicare and Medicaid Services (CMS), in a final national policy decision, is allowing Medicare to cover the cost of Aduhelm (aducanumab) and other medicines in its class given accelerated approval only for Alzheimer’s disease patients enrolled in qualifying clinical trials. Should Adulhelm or future amyloid-targeting monoclonal antibodies be given standard or full — rather than…
AL001 May Deliver Lithium’s Benefits for Dementia With Less Toxicity
Alzamend Neuro’s experimental oral therapy for dementia related to Alzheimer’s disease may deliver the benefits of marketed lithium-based treatments but with fewer side effects, data from a completed Phase 1 trial show. A 150 milligrams (mg) dose of the therapy, called AL001, led to similar levels of lithium in the blood as a 300 mg…
#AAN2022 – SAGE-718 May Help With Cognitive Function in Alzheimer’s
Treatment with the investigational candidate SAGE-718 was generally well-tolerated and associated with cognitive improvements in people with Alzheimer’s disease, according to preliminary results from the LUMINARY Phase 2 clinical trial. The therapy’s developer, Sage Therapeutics, presented these findings in a talk, titled “SAGE-718 in Patients With Mild Cognitive Impairment or Mild Dementia Due to Alzheimer’s…
Biogen Submits Final Protocol for Phase 4 Aduhelm Study to FDA
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 patient is expected in May, according to Biogen’s press…