Excellent point. If Anavex wants to get approval for Alzheimer related sleep disturbances, they will need to run appropriate studies. The A273 sleep claims are based on 8 patients in the phase 2a who reported sleep issues based on 3 questions in the 17 question HAM-D depression inventory. The 8 patients in the uncontrolled study who reported sleep issues at baseline did not report sleep issues at 31 weeks (unclear if any further timepoints were tested and if so what the results were). The phase 2b/3 has only one sleep measure listed as an endpoint (RSCAQ, a scale of sleep continuity I could not find any information about). One subjective scale, even if it shows significance, is unlikely to lead to approval.
As a comparison, Merck just reported their study of Belsomra (Suvorexant) for sleep disturbances in Alzheimer. This 264 patient study measured sleep with polysomnogram (the gold standard for sleep) and also measured CGI-S and a caregiver-reported participant subjective Sleep Quality Rating (sSQR). Results were significant for primary and secondary endpoints and Merck will be submitting an application to the FDA to get Suvorexant approved for Alzheimer related insomnia.
Best of luck with your son's sleep issues. One of my nephews has Autism and had sleep issues when younger but has done well as a teenager.
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