Evidence map›Paper›PMID 26089183›Full record

Trial reportNeuropsychopharmacology : official publication of the American College of Neuropsychopharmacology2015

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

Richard S E Keefe, Herbert A Meltzer, Nancy Dgetluck, Maria Gawryl, Gerhard Koenig, Hans J Moebius, Ilise Lombardo, Dana C Hilt

Open access · hybridAbstract readMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacology, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 84 papers, 6 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
84citing papers in PubMed, 6 pooled it
9.9field-weighted citation impact, top 1% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

84 citing papers in PubMed, 6 syntheses or guidelines pooled it, 144 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Selective 5HT3 antagonists and sensory processing: a systematic review.Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacology · 2022
    Pooled it
  4. Pooled it
  5. Pooled it
  6. Pooled it
  7. Trial
  8. Trial
  9. Trial
  10. Trial
  11. Trial
  12. Pharmacokinetic Limitations on Effects of an Alpha7-Nicotinic Receptor Agonist in Schizophrenia: Randomized Trial with an Extended-Release Formulation.Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacology · 2018
    Trial
  13. Trial
  14. Review
  15. Review
  16. Review
  17. Review
  18. Review
  19. Article
  20. RIC-3 Interacts Directly with the 5-HTbioRxiv : the preprint server for biology · 2026
    Article

24 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

8 authors at 2 institutions in 1 country.

Richard S E KeefeDepartment of Psychiatry and Behavioral Sciences, Duke University Medical Center, Durham, NC, USA.
Herbert A MeltzerDepartment of Psychiatry and Behavioral Sciences Psychiatry, Northwestern University, Feinberg School of Medicine, USA.
Nancy DgetluckFORUM Pharmaceuticals Inc., Waltham, MA, USA.
Maria GawrylFORUM Pharmaceuticals Inc., Waltham, MA, USA.
Gerhard KoenigFORUM Pharmaceuticals Inc., Waltham, MA, USA.
Hans J MoebiusFORUM Pharmaceuticals Inc., Waltham, MA, USA.
Ilise LombardoFORUM Pharmaceuticals Inc., Waltham, MA, USA.
Dana C HiltFORUM Pharmaceuticals Inc., Waltham, MA, USA.
Duke Medical Center · USNorthwestern University · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

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.

Indexed as

AdolescentAdultalpha7 Nicotinic Acetylcholine ReceptorAntipsychotic AgentsCognitionCognition DisordersDouble-Blind MethodFemaleHumansMaleMiddle AgedNicotinic AgonistsPsychiatric Status Rating ScalesPsychotropic DrugsQuinuclidinesSchizophreniaalpha7 Nicotinic Acetylcholine ReceptorAntipsychotic AgentsN-(7-chloro-N-quinuclidin-3-yl)benzo(b)thiophene-2-carboxamideNicotinic AgonistsPsychotropic DrugsQuinuclidinesThiophenes

Identifiers

PMID26089183
PMCPMC4864641
OpenAlexW1523031842

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.