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 monitoring safety and tolerability, cerebrospinal fluid (CSF) and blood markers related to Alzheimer’s disease will be collected before and after treatment.
Patients who complete this study will be able to enroll in ATTENTION-AD, an open-label extension study, for an additional two years of Anavex 2-73 treatment.
Anavex 2-73 works by activating a cellular receptor called Sigma-1, known to have neuroprotective effects by reducing neuroinflammation, oxidative stress and blocking the accumulation of beta-amyloid and tau proteins. Of note, oxidative stress is an imbalance between the production of free radicals and the ability of cells to detoxify them, leading to cellular damage.
People with Alzheimer’s disease have fewer sigma-1 receptors in their brains compared to healthy people the same age. Activation of these receptors may improve the symptoms and protect against neurologic changes.
A previous 57-week Phase 2a study (NCT02244541) testing Anavex 2-73 in patients with mild-to-moderate Alzheimer’s disease resulted in a dose-dependent improvement in cognition and function. The researchers noted “unexpected” therapeutic responses, including improved mood and alertness, and better engagement with family and friends.
A open-label extension study (NCT02756858) for an additional 208 weeks, which included a full genomic analysis of Anavex 2-73-treated patients, continued to show a significant association between Anavex 2-73 dosage and cognitive and function improvements. Anavex was reported safe and well-tolerated throughout the study.
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