Israeli drug-development firm Neurim Pharmaceuticals has begun enrolling patients in its Phase II recognition study of piromelatine for mild Alzheimer’s disease (AD).
Piromelatine has been developed as a multi-target-directed melatonin receptors agonist MT1 / MT2 and serotonin 5HT1A/D receptors agonist.
The randomised, placebo controlled, dose ranging Phase II recognition study intends to evaluate the safety, efficacy and tolerability of piromelatine against placebo to address mild dementia, which is an AD induced symptom.
The trial will be conducted for a period of 26 weeks and will involve 500 patients diagnosed with mild AD and treated with stable doses of acetylcholinesterase inhibitors.
The patients will be administered with oral doses of piromelatine and placebo on a once-daily basis.
Neurim Pharmaceuticals clinical development vice-president Dr Amnon Katz said: “This study is the result of recent developments in AD research that recognise the role of deep sleep in the clearance of excessive amyloid burden from the brain.
“We are pleased to be taking this important step to investigate whether Piromelatine would be beneficial in improving cognitive performance in AD patients.”
Previously held clinical studies suggested the neuroprotection and neurogenesis potential of Piromelatine.
Another Phase II study has also demonstrated the efficacy of Piromelatine in improving sleep maintenance and more specifically, enhanced deep slow-wave sleep (SWS).