A Study to Evaluate ABT-126 for the Treatment of Cognitive Deficits in Schizophrenia

Summary

This is a safety and efficacy study evaluating a experimental treatment for cognitive deficits in adults with schizophrenia.

Timeline

Start

2012-05

Primary completion

2014-04

Completion

2014-07

Outcome

Missed primary endpoint

paper MCCB neurocognitive composite score (+2.66 [±0.54] for ABT-126 50 mg vs +2.46 [±0.56] for placebo at week 12; P>0.05) PMID 27319970 ↗

paper No statistically significant differences were observed in either the change from baseline for the MCCB neurocognitive composite score PMID 27319970 ↗

Publications

• Results Haig G, Wang D, Othman AA, Zhao J. The alpha7 Nicotinic Agonist ABT-126 in the Treatment of Cognitive Impairment Associated with Schizophrenia in Nonsmokers: Results from a Randomized Controlled Phase 2b Study. Neuropsychopharmacology. 2016 Nov;41(12):2893-2902. doi: 10.1038/npp.2016.101. Epub 2016 Jun 20.
• Georgiades A, Davis VG, Atkins AS, Khan A, Walker TW, Loebel A, Haig G, Hilt DC, Dunayevich E, Umbricht D, Sand M, Keefe RSE. Psychometric characteristics of the MATRICS Consensus Cognitive Battery in a large pooled cohort of stable schizophrenia patients. Schizophr Res. 2017 Dec;190:172-179. doi: 10.1016/j.schres.2017.03.040. Epub 2017 Apr 20.
• Bain EE, Shafner L, Walling DP, Othman AA, Chuang-Stein C, Hinkle J, Hanina A. Use of a Novel Artificial Intelligence Platform on Mobile Devices to Assess Dosing Compliance in a Phase 2 Clinical Trial in Subjects With Schizophrenia. JMIR Mhealth Uhealth. 2017 Feb 21;5(2):e18. doi: 10.2196/mhealth.7030.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	ABT-126	Small molecule	25 mg	—
Subject	ABT-126	Small molecule	50 mg	—
Subject	ABT-126	Small molecule	75 mg	—

Indications