Neurim Posts Positive Phase 2 Results For Alzheimer's Drug
Neurim Pharmaceuticals announced that it has published positive results from a Phase II trial investigating add-on Circadin (Prolonged Release melatonin 2mg) to standard therapy in Alzheimer's disease (AD) patients.
Circadin is a novel, regulatory-approved sleep medication indicated for the treatment of primary insomnia in patients age 55 and above. In the randomized, placebo-controlled, double-blind Phase II clinical trial, the drug was investigated against placebo in 80 patients diagnosed with mild-to-moderate Alzheimer's disease, with and without insomnia co-morbidity, and who are currently receiving standard therapy (acetylcholinesterase inhibitors with or without memantine). Results show that patients treated with Circadin for six months showed better cognitive performance as measured by Instrumental Activities of Daily Living (IADL) and Mini Mental State Examination (MMSE). Sleep efficiency was also improved with Circadin compared to placebo in patients with comorbid insomnia. Circadin was reported to be well tolerated.
Dr Tali Nir, head of clinical trials at Neurim Pharmaceuticals, said, “Endogenous melatonin levels are reduced already at preclinical AD stages. Because melatonin is important for good sleep quality and because poor sleep quality has recently been linked to AD, it was important to investigate whether replenishing the missing hormone would be beneficial in AD patients and whether such effects would be related to the improvement in sleep.”
Prof. Zisapel, CSO of Neurim Pharmaceutical, said that the company is happy with the positive efficacy and safety data of the investigational drug for 6 months on cognitive functioning and sleep in patients with mild-moderate AD. “This publication comes at an exciting time when the causal relationship between sleep disturbance and the AD-relevant accumulation of beta amyloid in brain was discovered. This study demonstrates the significance of good sleep quality and melatoninergic mechanisms in improving both cognition and sleep problems in Alzheimer patients and calls for further focus of this mechanism in AD treatment.”
The study results were published in the Clinical Interventions in Aging Journal.