In 1st Human Trials, Drug Improves Memory in Alzheimer's Patients
(HealthDay News) – In a first report of human trials, a selective alpha-2C adrenoceptor antagonist improves memory in patients with Alzheimer's disease (AD), according to a study to be presented at the annual meeting of the American Academy of Neurology, held from March 16–23 in San Diego.
Juha Rouru, MD, from Orion Pharma in Turku, Finland, and colleagues conducted a phase IIa, double-blind, placebo-controlled study in which 100 moderate AD patients (Mini-Mental State Examination scores of 12–21) with behavioral symptoms (Neuropsychiatric Inventory [NPI] score of ≥15) were randomized to two flexible dose levels of either 30–60mg or 100–200mg of ORM-12741 or matching placebo twice daily for 12 weeks as add-on to their stable cholinesterase inhibitor therapy (plus/minus memantine). Efficacy was assessed primarily with computerized tests from the Clinical Dementia Rating system, from which standard composite scores were derived, including Quality of Episodic Memory (QEM), Quality of Working Memory (QWM), Quality of Memory (QM), and Speed of Memory and Power of Attention. Behavioral and psychological symptoms were quantified with NPI.
The researchers found that there were statistically significant positive treatment effects for ORM-12741 on QEM and QM compared to the placebo group over the 12-week treatment period. There were no clear differences in efficacy between the two active-dose groups. A positive trend was also noted for both QWM and NPI total score, primarily for the low-dose group. For the other scores, there were no significant differences. ORM-12741 was generally well tolerated.
"Currently, there are still only a handful of Alzheimer's drugs on the market, and they have only moderate effects on the symptoms of the disease," Rouru said in a statement.
Several authors disclosed financial ties to Orion Pharma, which funded the study.