ORM-12741 is a potential treatment for Alzheimer’s disease being developed by the Finnish pharmaceutical company Orion. This medication is intended to treat memory loss as well as neuropsychiatric symptoms in Alzheimer’s, such as aggression, delusions, social withdrawal, and mood swings.
How ORM-12741 works
ORM-12741 acts on the α 2c adrenergic receptor on brain cells. The role of this receptor in Alzheimer’s disease is not well understood, but it is thought to be involved in the release of neurotransmitters in the brain, especially in stressful situations. Neurotransmitters are chemical messengers that carry signals between nerve cells.
Studies in mice have shown that the α 2c adrenergic receptor may also affect cognition.
ORM-12741 is an α 2c adrenergic receptor “antagonist.” This means that it binds to and blocks the receptor’s activity.
ORM-12741 in clinical trials
Several Phase 1 clinical trials conducted in healthy volunteers demonstrated that ORM-12741 is safe, well-tolerated, and can be taken orally.
ORM-12741 was also tested for efficacy and safety in a Phase 2 clinical trial (NCT01324518) in 100 Alzheimer’s patients also taking cholinesterase inhibitors as standard treatment. Participants were given either a high dose of ORM-12741 (200 mg), a low dose of ORM-12741 (60 mg), or a placebo twice a day for 12 weeks. They were then assessed using the cognitive drug research computerized assessment system and the neuropsychiatric inventory.
Results showed a small but significant improvement in episodic memory, or memory about autobiographical events, in patients given either dose of ORM-12741 compared to those who received placebo. Findings also suggested that ORM-12741 may slightly improve neuropsychiatric symptoms. Overall, ORM-12741 proved safe for use in Alzheimer’s patients.
A second, larger Phase 2 clinical trial (NCT02471196) in some 308 Alzheimer’s patients focused more specifically on ORM-12741’s potential effects on symptoms of agitation and aggression. This study was completed at the end of 2017, but results have not been published yet. But news released has not been favorable. Orion’s president and CEO, Timo Lappalainen, stated in a February 2018 company financial statement that “the trial did not meet the efficacy objectives set for the product,” and Orion would be evaluating results with its partner Janssen Pharmaceuticals.
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