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

Primary Purpose

Schizophrenia

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
ABT-126
ABT-126
Placebo
Sponsored by
AbbVie (prior sponsor, Abbott)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Schizophrenia focused on measuring schizophrenia

Eligibility Criteria

20 Years - 55 Years (Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Site Reference ID/Investigator# 74436
  • Site Reference ID/Investigator# 72704
  • Site Reference ID/Investigator# 72699
  • Site Reference ID/Investigator# 73983
  • Site Reference ID/Investigator# 73236
  • Site Reference ID/Investigator# 86974
  • Site Reference ID/Investigator# 72701
  • Site Reference ID/Investigator# 75314
  • Site Reference ID/Investigator# 75146
  • Site Reference ID/Investigator# 75654
  • Site Reference ID/Investigator# 72703
  • Site Reference ID/Investigator# 76534
  • Site Reference ID/Investigator# 73984
  • Site Reference ID/Investigator# 73981
  • Site Reference ID/Investigator# 89553
  • Site Reference ID/Investigator# 72700
  • Site Reference ID/Investigator# 73982
  • Site Reference ID/Investigator# 113035
  • Site Reference ID/Investigator# 72702
  • Site Reference ID/Investigator# 75147

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

ABT-126 Low Dose

ABT-126 High Dose

Placebo

Arm Description

ABT-126 Low Dose

ABT-126 High Dose

Placebo

Outcomes

Primary Outcome Measures

Cognition: MCCB (MATRICS Consensus Cognitive Battery) change from baseline to week 12
Rater based interview

Secondary Outcome Measures

Functioning: UPSA-2 (University of California San Diego Performance-based Skills Assessment-2)
Rater based interview
Symptom Severity: PANSS (Positive and Negative Syndrome Scale)
Rater based interview
Symptom Severity: NSA-16 (16-item version of the Negative Symptom Assessment Scale)
Rater based interview

Full Information

First Posted
August 31, 2012
Last Updated
July 2, 2021
Sponsor
AbbVie (prior sponsor, Abbott)
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1. Study Identification

Unique Protocol Identification Number
NCT01678755
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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2021
Overall Recruitment Status
Completed
Study Start Date
August 2012 (undefined)
Primary Completion Date
March 2014 (Actual)
Study Completion Date
March 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AbbVie (prior sponsor, Abbott)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia
Keywords
schizophrenia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
157 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ABT-126 Low Dose
Arm Type
Experimental
Arm Description
ABT-126 Low Dose
Arm Title
ABT-126 High Dose
Arm Type
Experimental
Arm Description
ABT-126 High Dose
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo
Intervention Type
Drug
Intervention Name(s)
ABT-126
Intervention Description
ABT-126 Low Dose
Intervention Type
Drug
Intervention Name(s)
ABT-126
Intervention Description
ABT-126 High Dose
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo
Primary Outcome Measure Information:
Title
Cognition: MCCB (MATRICS Consensus Cognitive Battery) change from baseline to week 12
Description
Rater based interview
Time Frame
Change from baseline to week 12
Secondary Outcome Measure Information:
Title
Functioning: UPSA-2 (University of California San Diego Performance-based Skills Assessment-2)
Description
Rater based interview
Time Frame
Measurements from screening period up through week 12
Title
Symptom Severity: PANSS (Positive and Negative Syndrome Scale)
Description
Rater based interview
Time Frame
Measurements from screening period up through week 12
Title
Symptom Severity: NSA-16 (16-item version of the Negative Symptom Assessment Scale)
Description
Rater based interview
Time Frame
Measurements from screening period up through week 12

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
George Haig, PharmD
Organizational Affiliation
AbbVie
Official's Role
Study Director
Facility Information:
Facility Name
Site Reference ID/Investigator# 74436
City
Chino
State/Province
California
ZIP/Postal Code
91710
Country
United States
Facility Name
Site Reference ID/Investigator# 72704
City
Garden Grove
State/Province
California
ZIP/Postal Code
92845
Country
United States
Facility Name
Site Reference ID/Investigator# 72699
City
National City
State/Province
California
ZIP/Postal Code
91950
Country
United States
Facility Name
Site Reference ID/Investigator# 73983
City
Oceanside
State/Province
California
ZIP/Postal Code
92056
Country
United States
Facility Name
Site Reference ID/Investigator# 73236
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States
Facility Name
Site Reference ID/Investigator# 86974
City
San Diego
State/Province
California
ZIP/Postal Code
92102
Country
United States
Facility Name
Site Reference ID/Investigator# 72701
City
Torrance
State/Province
California
ZIP/Postal Code
90502
Country
United States
Facility Name
Site Reference ID/Investigator# 75314
City
Bradenton
State/Province
Florida
ZIP/Postal Code
34201
Country
United States
Facility Name
Site Reference ID/Investigator# 75146
City
Maitland
State/Province
Florida
ZIP/Postal Code
32751
Country
United States
Facility Name
Site Reference ID/Investigator# 75654
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30308
Country
United States
Facility Name
Site Reference ID/Investigator# 72703
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60640
Country
United States
Facility Name
Site Reference ID/Investigator# 76534
City
Hoffman Estates
State/Province
Illinois
ZIP/Postal Code
60169
Country
United States
Facility Name
Site Reference ID/Investigator# 73984
City
Lake Charles
State/Province
Louisiana
ZIP/Postal Code
70629
Country
United States
Facility Name
Site Reference ID/Investigator# 73981
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63109
Country
United States
Facility Name
Site Reference ID/Investigator# 89553
City
Marlton
State/Province
New Jersey
ZIP/Postal Code
08053
Country
United States
Facility Name
Site Reference ID/Investigator# 72700
City
Cedarhurst
State/Province
New York
ZIP/Postal Code
11516
Country
United States
Facility Name
Site Reference ID/Investigator# 73982
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Facility Name
Site Reference ID/Investigator# 113035
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73116
Country
United States
Facility Name
Site Reference ID/Investigator# 72702
City
DeSoto
State/Province
Texas
ZIP/Postal Code
75115
Country
United States
Facility Name
Site Reference ID/Investigator# 75147
City
Houston
State/Province
Texas
ZIP/Postal Code
77008
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
28922590
Citation
Haig GM, Wang D, Zhao J, Othman AA, Bain EE. Efficacy and Safety of the alpha7-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):16m11162. doi: 10.4088/JCP.16m11162.
Results Reference
result
PubMed Identifier
28433500
Citation
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.
Results Reference
derived

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

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