ABT-126 study in Cognitive Deficits in Schizophrenia in non-smokers

• Research type

  Research Study

• Full title

  A Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging, Parallel-Group, Phase 2 Study of the Safety and Efficacy of ABT-126 in the Treatment of Cognitive Deficits in Schizophrenia (CDS) in Nonsmokers

• IRAS ID

  108903

• Contact name

  Sukhwinder Shergill

• Sponsor organisation

  Abb Vie Deutschland GmBH & Co.KG

• Eudract number

  2012-000418-13

• ISRCTN Number

  n/a

• Clinicaltrials.gov Identifier

  n/a

• Research summary

  This study will look at how safe and effective a drug called ABT-126 is in the treatment of cognitive deficits in schizophrenia (CDS). It is relevant and important because there are currently no drugs that treat CDS and so there is a significant medical need for a drug to treat this problem.  Patients with schizophrenia have a variety of symptoms, including deficiencies in cognitive functioning which is the ability to pay attention, concentrate, remember things and learn new information.  ABT-126 is under development at AbbVie for the treatment of CDS. ABT-126 targets part of the brain which is responsible for cognition (paying attention, remembering, learning). The purpose of this study is to find out whether ABT-126 is safe and improves cognition in patients who are already taking medications approved for treating other schizophrenia symptoms.  A total of 430 patients who have been diagnosed with schizophrenia, aged between 20 and 65, who are clinically stable and who are receiving one or two other treatments for their disease may be able to take part. Approximately 50 patients will be recruited in the UK.  Patients will attend regular study visits at a study centre. The effect of the drug on CDS will be checked by asking the patients to answer questionnaires about how they are doing and by performing cognitive assessments. Safety of the patient will also be checked throughout the study by doing blood tests, ECGs (traces of the heart) and physical examinations.  Patients will attend 2 visits to check if they can enter the study. Patients will be treated with the study drug for 24 weeks. They will see the study doctor about every 2 weeks. Patients will receive either one of three doses of ABT-126 or placebo (which has no active ingredient).

• REC name

  South Central - Hampshire A Research Ethics Committee

• REC reference

  12/SC/0544

• Date of REC Opinion

  21 Dec 2012

• REC opinion

  Further Information Favourable Opinion