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Tolerability of ORM-12741 and effects on episodic memory in patients with Alzheimer's disease
| Content Provider | Scilit |
|---|---|
| Author | Rinne, Juha O. Wesnes, Keith Cummings, Jeffrey L. Hakulinen, Pasi Hallikainen, Merja Hänninen, Jutta Murphy, Michael Riordan, Henry Scheinin, Mika Soininen, Hilkka Rouru, Juha |
| Copyright Year | 2016 |
| Description | Journal: Alzheimer's & Dementia: Translational Research & Clinical Interventions ORM-12741 is a novel selective antagonist of alpha-2C adrenoceptors. This trial evaluated the safety and efficacy of ORM-12741 in patients with Alzheimer's disease (AD). A randomized, double-blind, placebo-controlled, exploratory phase 2a trial was conducted in 100 subjects with AD and neuropsychiatric symptoms. Participants were randomized to receive one of two flexible doses of ORM-12741 (30–60 mg or 100–200 mg) or placebo b.i.d. for 12 weeks in addition to standard therapy with cholinesterase inhibitors. Efficacy was assessed primarily with the Cognitive Drug Research (CDR) computerized assessment system and secondarily with the Neuropsychiatric Inventory (NPI). A statistically significant treatment effect was seen in one of the four primary CDR system end points, Quality of Episodic Memory (P = .030; not adjusted for multiple comparisons), favoring ORM-12741 over placebo. NPI caregiver distress scores also favored ORM-12741 (P = .034). ORM-12741 was well tolerated. This is the first clinical trial providing evidence on an acceptable safety profile for ORM-12741 in patients with AD and neuropsychiatric symptoms. In addition, the trial provided hints of potential therapeutic benefit, primarily on episodic memory, in this patient population. |
| Related Links | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5651366/pdf |
| Ending Page | 9 |
| Page Count | 9 |
| Starting Page | 1 |
| ISSN | 23528737 |
| e-ISSN | 23528737 |
| DOI | 10.1016/j.trci.2016.11.004 |
| Journal | Alzheimer's & Dementia: Translational Research & Clinical Interventions |
| Issue Number | 1 |
| Volume Number | 3 |
| Language | English |
| Publisher | Wiley-Blackwell |
| Publisher Date | 2016-12-08 |
| Access Restriction | Open |
| Subject Keyword | Journal: Alzheimer's & Dementia: Translational Research & Clinical Interventions Clinical Psychology Alzheimer's Disease Alpha-2c Adrenoceptor Antagonist Randomized Trials Behavioral and Psychological Symptoms of Dementia Neuropsychiatric Symptoms |
| Content Type | Text |
| Resource Type | Article |
| Subject | Neurology (clinical) Psychiatry and Mental Health |