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A randomized, double-blind, placebo-controlled crossover study of α4β2* nicotinic acetylcholine receptor agonist AZD1446 (TC-6683) in adults with attention-deficit/hyperactivity disorder

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Abstract

Rationale

Stimulation of nicotinic cholinergic systems has been shown to alleviate ADHD symptoms and to improve cognitive performance. AZD1446 is a selective α4β2* nicotinic acetylcholine receptor agonist with potential effect on the symptoms of ADHD.

Objectives

The purpose of this study is to evaluate the efficacy, safety, and pharmacokinetics of AZD1446 in adults with ADHD treated for 2 weeks.

Method

This was a randomized, double-blind, placebo-controlled crossover trial. Participants were 79 adults with ADHD, grouped according to their use of nicotine-containing products. Nicotine non-users received placebo and two of three AZD1446 treatment regimens (80 mg tid, 80 mg qd, 10 mg tid). Nicotine users received placebo, AZD1446 80 mg tid and 80 mg qd. Efficacy measures included the Conners' Adult ADHD Rating Scale and cognitive measures of immediate and delayed verbal episodic memory, learning, attention, working memory, executive functioning, and spatial problem solving (CogState computerized test battery).

Results

There was no significant effect of AZD1446 on any of the clinical scores irrespective of dose, schedule, or concomitant use of nicotine products. A statistically significant improvement was seen on the Groton Maze Learning Task, a measure of executive functioning, in nicotine non-users after treatment with AZD1446 80 mg qd.

Conclusions

AZD1446 was well tolerated, but did not significantly improve ADHD symptoms after 2 weeks of treatment compared to placebo. While the present study does not support the therapeutic utility of AZD1446 in ADHD, its potential pro-cognitive effects remain to be explored in other neuropsychiatric disorders.

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Acknowledgments

The authors wish to acknowledge the following investigators for their contributions to this study: Jerry C. Steiert, M.D. (Summit Research Network (Seattle), LLC, Seattle, WA); John K. Heussy, M.D. (New York, NY); John F. Prater, M.D. (Nova Southeastern University, Ft. Lauderdale and Gulfcoast Clinical Research Center, Fort Myers, FL); Donald Garcia, M.D. (FutureSearch Trials, LLC, Austin, TX); Nader Oskooilar, M.D., Ph.D. (Pharmacology Research Institute, Los Alamitos, LA). The authors wish to thank members of the AstraZeneca study team: Hans-Göran Hårdemark for the input to the study design, critical reviews; Edwin Johnson for the input to the discussion; Sara Lindholm for the assistance with the study design; Lili Ghavamzadeh for the operational assistance; Dennis Sweitzer for the statistical analysis; and Jacob Brogren for the pharmacokinetic modelling. The authors are grateful to David Hosford (Targacept, Inc.) for the manuscript review and valuable comments.

Declaration of conflicting interests

This study was funded by AstraZeneca, R&D, Södertälje, Sweden [ClinicalTrials.gov Identifier: NCT01012375; http://clinicaltrials.gov/ct2/show/NCT01012375?term = AZD1446&rank = 4]. AstraZeneca was involved in the original concepts and systematic review of existing trial evidence, the design, the choice of investigators, the control of the allocation schedule, the conduct of the trial, the collection and monitoring of data, data analysis and interpretation, and the writing and approval of this report. The authors have had full control of all primary data and agree to allow the journal to review the data if requested.

Disclosures

Authors AJ, JÖ, JJ, PK, KH, EB, and BP were full-time AstraZeneca employees during the study design, conduct, data analysis and writing period, and received salary and stock from AstraZeneca. Prof. Paul A. Newhouse is supported by the National Institute of Aging (NIMH) Grant, has received speaking fees, consulting fees, and research grants from AstraZeneca, Lilly, and Sanofi-Aventis. PN and AP have no financial involvement or commercial interest in the AstraZeneca products under study and received no financial remuneration.

Author information

Author notes

  1. John Öhd

    Present address: Shire AG, Eysins, Switzerland

  2. Judith Jaeger

    Present address: CogState, Inc., New Haven, CT, USA

  3. Kristin Hannesdottir

    Present address: AstraZeneca, Cambridge, MA, USA

  4. Pär Karlsson

    Present address: Central Statistical Bureau of Sweden, Stockholm, Sweden

  5. Björn Paulsson

    Present address: Swedish Orphan Biovitrum AB, Stockholm, Sweden

Authors and Affiliations

  1. AstraZeneca R&D, Södertälje, Sweden

    Aurelija Jucaite, John Öhd, Pär Karlsson, Kristin Hannesdottir, Emma Boström & Björn Paulsson

  2. University of Vermont College of Medicine, Burlington, VT, USA

    Alexandra S. Potter & Paul A. Newhouse

  3. AstraZeneca R&D, Wilmington, DE, USA

    Judith Jaeger

  4. Center for Cognitive Medicine, Vanderbilt University School of Medicine, Nashville, TN, USA

    Paul A. Newhouse

  5. Department of Clinical Neuroscience, AstraZeneca Translational Science Center, Karolinska Institutet, 171 65, Solna, Sweden

    Aurelija Jucaite

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Jucaite, A., Öhd, J., Potter, A.S. et al. A randomized, double-blind, placebo-controlled crossover study of α4β2* nicotinic acetylcholine receptor agonist AZD1446 (TC-6683) in adults with attention-deficit/hyperactivity disorder. Psychopharmacology 231, 1251–1265 (2014). https://doi.org/10.1007/s00213-013-3116-7

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