Anavex Life Sciences Corp (AVXL)

[F1ash]

In most drug trials the control group is not a placebo but is the current Standard of care.

In the case of 2-73 there really isn't a standard of care to use as a control group.

An as yet unknown portion (possibly all) of the patients in the PDD trial may be taking the current SOC drugs for the disease .
(I believe the same is true for the AZ trial as well)


“Stable regimen of anti-Parkinson's disease medications (including levodopa, dopamine agonists, MAO-B inhibitors, or the COMT inhibitor entacapone), which has been stable for at least 4 weeks prior to Baseline.

Treatment with cholinesterase inhibitor (rivastigmine, donepezil and galantamine (Exelon®, Aricept®, or Reminyl®) will be permitted, provided the dose has been stable for a minimum of 8 weeks prior to randomization.

Subjects with history of depression on antidepressant medications will be allowed if depression is controlled and they have been on a stable daily dose of the antidepressant for ≥8 weeks before Baseline.”


https://clinicaltrials.gov/ct2/show/NCT03774459?term=Anavex&draw=2&rank=6


“Cholinesterase inhibitors — drugs that are the current mainstay for treating cognitive changes in Alzheimer's — may help Parkinson's disease dementia symptoms, including visual hallucinations, sleep disturbances and changes in thinking and behavior.

Antipsychotic drugs — a drug category sometimes prescribed for behavioral symptoms of Alzheimer’s — should be used with extreme caution because they may cause serious side effects in up to 50% of those with Parkinson’s disease dementia or Lewy body dementia. Side effects may include sudden changes in consciousness, impaired swallowing, acute confusion, episodes of delusions or hallucinations, or appearance or worsening of Parkinson’s symptoms.

Treating movement symptoms in those with Parkinson’s dementia can be challenging, because carbidopa-levodopa — the chief treatment for Parkinson’s movement symptoms — can sometimes aggravate hallucinations and confusion in those with Parkinson’s dementia or Lewy body dementia.”


https://www.alz.org/alzheimers-dementia/what-is-dementia/types-of-dementia/parkinson-s-disease-dementia