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Randomized, Double-Blind, Placebo-Controlled Study of Encenicline, an α7 Nicotinic Acetylcholine Receptor Agonist, as a Treatment for Cognitive Impairment in Schizophrenia.

Publication ,  Journal Article
Keefe, RSE; Meltzer, HA; Dgetluck, N; Gawryl, M; Koenig, G; Moebius, HJ; Lombardo, I; Hilt, DC
Published in: Neuropsychopharmacology
December 2015

Encenicline is a novel, selective α7 nicotinic acetylcholine receptor agonist in development for treating cognitive impairment in schizophrenia and Alzheimer's disease. A phase 2, double-blind, randomized, placebo-controlled, parallel-design, multinational study was conducted. Patients with schizophrenia on chronic stable atypical antipsychotics were randomized to encenicline 0.27 or 0.9 mg once daily or placebo for 12 weeks. The primary efficacy end point was the Overall Cognition Index (OCI) score from the CogState computerized battery. Secondary end points include MATRICS Consensus Cognitive Battery (MCCB) (in US patients), the Schizophrenia Cognition Rating Scale (SCoRS) total score, SCoRS global rating, and Positive and Negative Syndrome Scale (PANSS) total and subscale and cognition factor scores. Of 319 randomized patients, 317 were included in the safety population, and 307 were included in the intent-to-treat population. Notable trends in improvement were demonstrated across all cognition scales. For the OCI score, the LS mean difference for encenicline 0.27 mg vs placebo was significant (Cohen's d=0.257; P=0.034). Mean SCoRS total scores decreased showing improvement in function over time, and the difference was significant for encenicline 0.9 mg vs placebo (P=0.011). Furthermore, the difference between encenicline 0.9 mg and placebo was significant for the PANSS Cognition Impairment Domain (P=0.0098, Cohen's d=0.40) and for the PANSS Negative scale (P=0.028, Cohen's d=0.33). Treatment-emergent adverse events were reported at similar frequencies across all treatment groups (39.0% with placebo, 23.4% with encenicline 0.27 mg, and 33.3% with encenicline 0.9 mg). Overall, encenicline was generally well tolerated and demonstrated clinically meaningful improvements in cognition and function in patients with schizophrenia.

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Published In

Neuropsychopharmacology

DOI

EISSN

1740-634X

Publication Date

December 2015

Volume

40

Issue

13

Start / End Page

3053 / 3060

Location

England

Related Subject Headings

  • alpha7 Nicotinic Acetylcholine Receptor
  • Young Adult
  • Treatment Outcome
  • Thiophenes
  • Schizophrenic Psychology
  • Schizophrenia
  • Quinuclidines
  • Psychotropic Drugs
  • Psychiatry
  • Psychiatric Status Rating Scales
 

Citation

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Keefe, R. S. E., Meltzer, H. A., Dgetluck, N., Gawryl, M., Koenig, G., Moebius, H. J., … Hilt, D. C. (2015). Randomized, Double-Blind, Placebo-Controlled Study of Encenicline, an α7 Nicotinic Acetylcholine Receptor Agonist, as a Treatment for Cognitive Impairment in Schizophrenia. Neuropsychopharmacology, 40(13), 3053–3060. https://doi.org/10.1038/npp.2015.176
Keefe, Richard S. E., Herbert A. Meltzer, Nancy Dgetluck, Maria Gawryl, Gerhard Koenig, Hans J. Moebius, Ilise Lombardo, and Dana C. Hilt. “Randomized, Double-Blind, Placebo-Controlled Study of Encenicline, an α7 Nicotinic Acetylcholine Receptor Agonist, as a Treatment for Cognitive Impairment in Schizophrenia.Neuropsychopharmacology 40, no. 13 (December 2015): 3053–60. https://doi.org/10.1038/npp.2015.176.
Keefe RSE, Meltzer HA, Dgetluck N, Gawryl M, Koenig G, Moebius HJ, et al. Randomized, Double-Blind, Placebo-Controlled Study of Encenicline, an α7 Nicotinic Acetylcholine Receptor Agonist, as a Treatment for Cognitive Impairment in Schizophrenia. Neuropsychopharmacology. 2015 Dec;40(13):3053–60.
Keefe, Richard S. E., et al. “Randomized, Double-Blind, Placebo-Controlled Study of Encenicline, an α7 Nicotinic Acetylcholine Receptor Agonist, as a Treatment for Cognitive Impairment in Schizophrenia.Neuropsychopharmacology, vol. 40, no. 13, Dec. 2015, pp. 3053–60. Pubmed, doi:10.1038/npp.2015.176.
Keefe RSE, Meltzer HA, Dgetluck N, Gawryl M, Koenig G, Moebius HJ, Lombardo I, Hilt DC. Randomized, Double-Blind, Placebo-Controlled Study of Encenicline, an α7 Nicotinic Acetylcholine Receptor Agonist, as a Treatment for Cognitive Impairment in Schizophrenia. Neuropsychopharmacology. 2015 Dec;40(13):3053–3060.

Published In

Neuropsychopharmacology

DOI

EISSN

1740-634X

Publication Date

December 2015

Volume

40

Issue

13

Start / End Page

3053 / 3060

Location

England

Related Subject Headings

  • alpha7 Nicotinic Acetylcholine Receptor
  • Young Adult
  • Treatment Outcome
  • Thiophenes
  • Schizophrenic Psychology
  • Schizophrenia
  • Quinuclidines
  • Psychotropic Drugs
  • Psychiatry
  • Psychiatric Status Rating Scales