The multicentre, placebo-controlled, double-blind, randomised study was carried out at 52 medical research centres/hospitals in five countries.
It enrolled 508 patients with early symptomatic Alzheimer’s disease associated with mild cognitive impairment or mild dementia.
Out of the total participants, 338 received blarcamesine oral capsules and the remaining were given placebo once daily for 48 weeks.
Using a mixed model for repeated measures (MMRM), the company analysed all the prespecified clinical endpoints.
The trial met the co-primary endpoints as the differences in the least-squares mean (LSM) change from baseline to 48 weeks between the blarcamesine and placebo groups were −1.783 for ADAS-Cog13, and −0.456 for CDR-SB.
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Reduction in both the pathological amyloid beta levels in plasma and the rate of pathological brain atrophy on magnetic resonance imaging scans was also observed.
Anavex Life Sciences president and CEO Christopher Missling said: “Alzheimer’s disease is such a devastating disease that affects tens of millions worldwide, and Anavex’s clinical development is a testament to our determination to follow the science.
“We like to thank all the people involved in the study for their invaluable contributions and we look forward to advancing blarcamesine as a potential new convenient orally available treatment option for Alzheimer’s disease.”
Anavex’s lead drug candidate, ANAVEX 2-73 restores cellular homeostasis by targeting muscarinic and sigma-1 receptors.
It also has the potential to treat additional CNS disorders, and in animal models demonstrated neuroprotective, anti-depressant, anticonvulsant, and anti-amnesic properties.