Date: 2013-03-21
Type of information: Initiation of preclinical development
phase: 2a
Announcement: presentation of results at the American Academy of Neurology\'s Annual Meeting in San Diego
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Company: Orion Corporation (Finland)
Product: ORM-12741
Action
mechanism: alpha-2c adrenoceptor antagonist. ORM-12741 is a selective alpha-2c adrenoceptor (AR) antagonist that has demonstrated efficacy in rodent models suggesting beneficial effects on cognition and behavioral symptoms in Alzheimer\'s disease, as well as good tolerability across seven phase I studies. It is the first drug to target a specific subtype of adrenergic receptors (alpha-2c) in the brain, which are believed to be involved in modulation of brain functions under stressful conditions.
Disease: Alzheimer's disease
Therapeutic area: Neurodegenerative diseases
Country:
Trial
details: For the clinical Phase IIa trial, 100 people with moderate Alzheimer\'s disease and with behavioral symptoms were randomly given either 30 to 60 milligrams or 100 to 200 mg 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 computerized 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 behavioral and psychological symptoms.
Latest
news: * On March 21, 2013, Orion Corporation has presented Phase II data for new Alzheimer\'s disease drug, ORM-12741, at American Academy of Neurology\'s Annual Meeting in San Diego. According to a Phase IIa study, ORM-12741 showed significant positive effects on episodic memory in patients with moderate Alzheimer\'s disease.
After three months, researchers retested several aspects of the participants\' memory and behavior. Those who took ORM-12741 tested higher on the tests of memory compared to those who received the placebo pill. At 3 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.
