A novel drug (ORM-12741) developed by Orion Corporation could improve cognitive and behavioural symptoms in patients with Alzheimer’s disease.
According to a Phase IIa study, presented yesterday at American Academy of Neurology’s Annual Meeting in San Diego, ORM-12741 showed significant positive effects on episodic memory in patients with moderate Alzheimer’s disease.
For the clinical Phase IIa trial, 100 people with moderate Alzheimer’s disease and with behavioural symptoms were randomly given either 30 to 60 milligrams or 100 to 200 milligrams of ORM-12741 or matching placebo pill twice a day for three months as add-on therapy to a cholinesterase inhibitor drug. Additionally, use of memantine was allowed. These are the other Alzheimer drugs currently on the market. Neither the researchers nor the participants knew which treatment they were receiving.
Efficacy was assessed primarily with computerised tests from CDR System, from which standard composite scores were derived including Quality of Episodic Memory, Quality of Working Memory, Quality of Memory, Speed of Memory and Power of Attention. Neuropsychiatric Inventory (NPI) was assessed to quantify the effects on behavioural and psychological symptoms.
After three months, researchers retested several aspects of the participants’ memory and behaviour. Those who took ORM-12741 tested higher on the tests of memory compared to those who received the placebo pill. At three months, the memory scores for those who received the placebo pill had worsened by 33%, whereas the scores improved by 4% for those who took ORM-12741.
Clear and statistically significant positive treatment effects were noted for ORM-12741 on Quality of Episodic Memory (p=0.03) and Quality of Memory (p=0.0127) compared to the placebo group over the 12 week treatment period with no clear difference in efficacy between the two active dose groups. In addition, a positive trend was noted for both Quality of Working memory and NPI total score primarily for the low dose group. No significant differences were identified on the other CDR scores. ORM-12741 was generally well tolerated in the study.
Professor Juha Rinne, the Principal Investigator of the ORM-12741 Proof of Concept study, commented:
“It is exciting to see clear effects demonstrated for the first time in patients with a molecule having a novel mode of action. It is encouraging to see that the effects are particularly clear in variables measuring episodic memory as defect in that is a hallmark of Alzheimer’s disease. The results are giving promise for potential to a completely new treatment option to these patients.”
Dr Reijo Salonen, Senior Vice President of R&D at Orion added:
“We are happy to see these promising results, especially given the challenges of demonstrating significant clinical improvement in this devastating disease. I am very proud of our scientists and clinicians, who are deeply committed to improving the lives of Alzheimer’s patients, and who have worked diligently to discover this compound and design a study that enabled the potential benefits to be revealed.”