A Phase 2 Study to Evaluate ABT-126 for the Treatment of Cognitive Deficits in Schizophrenia

• ClinicalTrials.gov Identifier: NCT01678755
• Recruitment Status: Completed
• First Posted: September 5, 2012
• Last Update Posted: March 24, 2015
• Sponsor: AbbVie (prior sponsor, Abbott)
• Information provided by (Responsible Party): AbbVie ( AbbVie (prior sponsor, Abbott) )

Tracking Information

• First Submitted Date: August 31, 2012
• First Posted Date: September 5, 2012
• Last Update Posted Date: March 24, 2015
• Study Start Date: August 2012
• Actual Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: October 24, 2012)

Cognition: MCCB (MATRICS Consensus Cognitive Battery) change from baseline to week 12 [ Time Frame: Change from baseline to week 12 ]

Rater based interview

Original Primary Outcome Measures (submitted: September 4, 2012)

Cognition: MCCB (MATRICS Consensus Cognitive Battery) change from baseline to week 24 [ Time Frame: Change from baseline to week 12 ]

Rater based interview

Current Secondary Outcome Measures (submitted: September 4, 2012)

• Functioning: UPSA-2 (University of California San Diego Performance-based Skills Assessment-2) [ Time Frame: Measurements from screening period up through week 12 ]
  Rater based interview
• Symptom Severity: PANSS (Positive and Negative Syndrome Scale) [ Time Frame: Measurements from screening period up through week 12 ]
  Rater based interview
• Symptom Severity: NSA-16 (16-item version of the Negative Symptom Assessment Scale) [ Time Frame: Measurements from screening period up through week 12 ]
  Rater based interview

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: A Phase 2 Study to Evaluate ABT-126 for the Treatment of Cognitive Deficits in Schizophrenia
• Official Title: A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Phase 2 Study of the Safety and Efficacy of ABT-126 in the Treatment of Cognitive Deficits in Schizophrenia (CDS) in Smokers
• Brief Summary: This is an efficacy study evaluating a experimental treatment for cognitive deficits in adults with schizophrenia.
• Detailed Description: Safety and Efficacy Study for Cognitive Deficits in Adult Subjects with Schizophrenia.
• Study Type: Interventional
• Study Phase: Phase 2
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Triple (Participant, Care Provider, Investigator); Primary Purpose: Treatment
• Condition: Schizophrenia

Intervention

• Drug: ABT-126
  ABT-126 Low Dose
• Drug: ABT-126
  ABT-126 High Dose
• Drug: Placebo
  Placebo

Study Arms

• Experimental: ABT-126 Low Dose
  ABT-126 Low Dose
  Intervention: Drug: ABT-126
• Experimental: ABT-126 High Dose
  ABT-126 High Dose
  Intervention: Drug: ABT-126
• Placebo Comparator: Placebo
  Placebo
  Intervention: Drug: Placebo

Publications *

• Haig GM, Wang D, Zhao J, Othman AA, Bain EE. Efficacy and Safety of the α7-Nicotinic Acetylcholine Receptor Agonist ABT-126 in the Treatment of Cognitive Impairment Associated With Schizophrenia: Results From a Phase 2b Randomized Controlled Study in Smokers. J Clin Psychiatry. 2018 May/Jun;79(3). pii: 16m11162. doi: 10.4088/JCP.16m11162.
• 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.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: March 4, 2015): 157
• Original Estimated Enrollment (submitted: September 4, 2012): 150
• Actual Study Completion Date: March 2014
• Actual Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

• Has a current Diagnostic and Statistical Manual of Mental Disorders-, 4th Edition, Text Revision (DSM-IV-TR) diagnosis of schizophrenia confirmed by the Mini-International Neuropsychiatric Interview (M.I.N.I.).
• Is clinically stable while receiving a regimen of one or two allowable antipsychotic medications; lack of hospitalizations in 4 months prior to initial screening visit; taking the same antipsychotic medication(s) for at least 8 weeks prior to baseline visit; core positive symptoms of Positive and Negative Syndrome Scale (PANSS) no worse than moderate in severity throughout screening period of at least 4 weeks.
• Has been diagnosed with or treated for schizophrenia for at least 2 years prior to initial screening visit.
• Has had continuity in psychiatric care (e.g., mental health system, clinic or physician) for at least 6 months prior to initial screening visit.
• Has an identified contact person (e.g., family member, social worker, case worker, or nurse) that can provide support to the subject to ensure compliance with protocol requirements.

Exclusion Criteria:

• In the Investigator's judgment, has a current or past diagnosis of schizoaffective disorder, bipolar disorder, manic episode, dementia, post traumatic stress disorder, or obsessive-compulsive disorder, or the subject has a current major depressive episode.
• Has a positive urine drug screen for cocaine, phencyclidine (PCP), opiates (unless duly prescribed), benzodiazepines (unless duly prescribed), marijuana, or amphetamines during the Screening Period.
• Has a current or past history of seizures, with the exception of a single febrile seizure occurring prior to 6 years of age.
• Has a clinically significant abnormal electrocardiogram (ECG) at Screening Visit 1 as determined by the Investigator.
• Has any risk factors for Torsades de Pointes (TdP)

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 20 Years to 55 Years (Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT01678755
• Other Study ID Numbers: M13-608
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: AbbVie ( AbbVie (prior sponsor, Abbott) )
• Study Sponsor: AbbVie (prior sponsor, Abbott)
• Collaborators: Not Provided

Investigators

• Study Director: George Haig, PharmD; AbbVie

• PRS Account: AbbVie
• Verification Date: March 2015