Anavex 2-73 Trial for Early Alzheimer’s Expanded to Canada, UK

Anavex 2-73 Trial for Early Alzheimer’s Expanded to Canada, UK
Anavex Life Sciences will expand its Phase 2b/3 clinical trial testing the efficacy and safety of Anavex 2-73 (blarcamesine) for the treatment of early Alzheimer’s disease into Canada and the United Kingdom (U.K.) following the go-ahead from Health Canada and the U.K.’s Medicines and Healthcare products Regulatory Agency (MHRA).  The clinical trial, dubbed Anavex 2-73-AD-004 (NCT03790709), is a placebo-controlled study currently underway in Australia, with more than 50% of the 450 patients enrolled. Participants are age 60 to 85 with mild cognitive impairment or early stage mild dementia due to Alzheimer’s. (More information about recruitment is available here.) “We are excited to receive the regulatory approvals for this Phase 2b/3 study for patients seeking treatment for Alzheimer’s disease,” said Christopher Missling, PhD, president and CEO of Anavex, in a press release. “This expansion into North America and Europe should accelerate the completion of the enrollment of the ongoing ANAVEX2-73-AD-004 Alzheimer’s disease Phase 2b/3 trial with ANAVEX2-73 (blarcamesine).” Given as an oral capsule, trial participants will receive one of two doses (a middle and high dose) of Anavex 2-73, or placebo, for about one year.  The primary outcome will be any changes in cognitive ability as assessed by the Alzheimer’s Disease Assessment Scale in cognition (ADAS-Cog), and the Alzheimer’s disease cooperative study-activities of daily living (ADCS-ADL). This test measures the competence of Alzheimer’s disease patients in daily living activities. Secondary outcomes include measures of sleep continuity regularly assessed with a questionnaire, as well as changes in the quality of life for both patients and caregivers.  In addition to monitor
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