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

Primary Purpose

Schizophrenia

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
ABT-126
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 - 65 Years (Adult, Older 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# 75139
  • Site Reference ID/Investigator# 74894
  • Site Reference ID/Investigator# 74434
  • Site Reference ID/Investigator# 76593
  • Site Reference ID/Investigator# 73213
  • Site Reference ID/Investigator# 72698
  • Site Reference ID/Investigator# 75057
  • Site Reference ID/Investigator# 72693
  • Site Reference ID/Investigator# 77655
  • Site Reference ID/Investigator# 74895
  • Site Reference ID/Investigator# 73977
  • Site Reference ID/Investigator# 73214
  • Site Reference ID/Investigator# 74453
  • Site Reference ID/Investigator# 74898
  • Site Reference ID/Investigator# 98016
  • Site Reference ID/Investigator# 86973
  • Site Reference ID/Investigator# 75140
  • Site Reference ID/Investigator# 73974
  • Site Reference ID/Investigator# 74433
  • Site Reference ID/Investigator# 72695
  • Site Reference ID/Investigator# 75136
  • Site Reference ID/Investigator# 75653
  • Site Reference ID/Investigator# 74893
  • Site Reference ID/Investigator# 72697
  • Site Reference ID/Investigator# 76533
  • Site Reference ID/Investigator# 75056
  • Site Reference ID/Investigator# 72694
  • Site Reference ID/Investigator# 75137
  • Site Reference ID/Investigator# 75053
  • Site Reference ID/Investigator# 75413
  • Site Reference ID/Investigator# 74553
  • Site Reference ID/Investigator# 72696
  • Site Reference ID/Investigator# 75055
  • Site Reference ID/Investigator# 74896
  • Site Reference ID/Investigator# 94476
  • Site Reference ID/Investigator# 79515
  • Site Reference ID/Investigator# 94528
  • Site Reference ID/Investigator# 79517
  • Site Reference ID/Investigator# 81934
  • Site Reference ID/Investigator# 81935
  • Site Reference ID/Investigator# 79516
  • Site Reference ID/Investigator# 83116
  • Site Reference ID/Investigator# 97136
  • Site Reference ID/Investigator# 81933
  • Site Reference ID/Investigator# 79514
  • Site Reference ID/Investigator# 80673
  • Site Reference ID/Investigator# 85093
  • Site Reference ID/Investigator# 97135
  • Site Reference ID/Investigator# 97137
  • Site Reference ID/Investigator# 83115
  • Site Reference ID/Investigator# 84733
  • Site Reference ID/Investigator# 79520
  • Site Reference ID/Investigator# 83117
  • Site Reference ID/Investigator# 97138
  • Site Reference ID/Investigator# 81938
  • Site Reference ID/Investigator# 81940
  • Site Reference ID/Investigator# 81939
  • Site Reference ID/Investigator# 92813
  • Site Reference ID/Investigator# 81937
  • Site Reference ID/Investigator# 81943
  • Site Reference ID/Investigator# 82238

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Placebo Comparator

Arm Label

ABT-126 Low Dose

ABT-126 Middle Dose

ABT-126 High Dose

Placebo

Arm Description

ABT-126 Low Dose

ABT-126 Middle Dose

ABT-126 High Dose

Placebo

Outcomes

Primary Outcome Measures

Cognition: MCCB (MATRICS Consensus Cognitive Battery)
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 Symptom Scale)
Rater based interview
Symptom Severity: NSA-16 (16-item version of the Negative Symptom Assessment Scale)
Rater based interview

Full Information

First Posted
May 25, 2012
Last Updated
July 2, 2021
Sponsor
AbbVie (prior sponsor, Abbott)
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1. Study Identification

Unique Protocol Identification Number
NCT01655680
Brief Title
A Study to Evaluate ABT-126 for the Treatment of Cognitive Deficits in Schizophrenia
Official 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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2021
Overall Recruitment Status
Completed
Study Start Date
May 2012 (undefined)
Primary Completion Date
April 2014 (Actual)
Study Completion Date
July 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 a safety and efficacy study evaluating a experimental treatment for cognitive deficits in adults with schizophrenia.
Detailed Description
This is a Phase 2 study designed to evaluate the safety and efficacy of ABT-126 in treating cognitive deficits in subjects with a diagnosis of schizophrenia. Eligible subjects will take study drug as an add-on treatment to their ongoing antipsychotic treatment regimen.

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
432 (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 Middle Dose
Arm Type
Experimental
Arm Description
ABT-126 Middle 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 Middle Dose
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)
Description
Rater based interview
Time Frame
Change from baseline to week 24
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 24
Title
Symptom Severity: PANSS (Positive and Negative Symptom Scale)
Description
Rater based interview
Time Frame
Measurements from screening period up through week 24
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 24

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
65 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# 75139
City
Anaheim
State/Province
California
ZIP/Postal Code
92804
Country
United States
Facility Name
Site Reference ID/Investigator# 74894
City
Bellflower
State/Province
California
ZIP/Postal Code
90706
Country
United States
Facility Name
Site Reference ID/Investigator# 74434
City
Chino
State/Province
California
ZIP/Postal Code
91710
Country
United States
Facility Name
Site Reference ID/Investigator# 76593
City
Costa Mesa
State/Province
California
ZIP/Postal Code
92626
Country
United States
Facility Name
Site Reference ID/Investigator# 73213
City
Escondido
State/Province
California
ZIP/Postal Code
92025
Country
United States
Facility Name
Site Reference ID/Investigator# 72698
City
Garden Grove
State/Province
California
ZIP/Postal Code
92845
Country
United States
Facility Name
Site Reference ID/Investigator# 75057
City
La Habra
State/Province
California
ZIP/Postal Code
90631
Country
United States
Facility Name
Site Reference ID/Investigator# 72693
City
National City
State/Province
California
ZIP/Postal Code
91950
Country
United States
Facility Name
Site Reference ID/Investigator# 77655
City
Norwalk
State/Province
California
ZIP/Postal Code
90650
Country
United States
Facility Name
Site Reference ID/Investigator# 74895
City
Oakland
State/Province
California
ZIP/Postal Code
94612
Country
United States
Facility Name
Site Reference ID/Investigator# 73977
City
Oceanside
State/Province
California
ZIP/Postal Code
92056
Country
United States
Facility Name
Site Reference ID/Investigator# 73214
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States
Facility Name
Site Reference ID/Investigator# 74453
City
Pico Rivera
State/Province
California
ZIP/Postal Code
90660
Country
United States
Facility Name
Site Reference ID/Investigator# 74898
City
Riverside
State/Province
California
ZIP/Postal Code
92506
Country
United States
Facility Name
Site Reference ID/Investigator# 98016
City
San Bernardino
State/Province
California
ZIP/Postal Code
92408
Country
United States
Facility Name
Site Reference ID/Investigator# 86973
City
San Diego
State/Province
California
ZIP/Postal Code
92102
Country
United States
Facility Name
Site Reference ID/Investigator# 75140
City
San Diego
State/Province
California
ZIP/Postal Code
92103
Country
United States
Facility Name
Site Reference ID/Investigator# 73974
City
San Gabriel
State/Province
California
ZIP/Postal Code
91776
Country
United States
Facility Name
Site Reference ID/Investigator# 74433
City
Santa Ana
State/Province
California
ZIP/Postal Code
92705
Country
United States
Facility Name
Site Reference ID/Investigator# 72695
City
Torrance
State/Province
California
ZIP/Postal Code
90502
Country
United States
Facility Name
Site Reference ID/Investigator# 75136
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06519
Country
United States
Facility Name
Site Reference ID/Investigator# 75653
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30308
Country
United States
Facility Name
Site Reference ID/Investigator# 74893
City
Marietta
State/Province
Georgia
ZIP/Postal Code
30060
Country
United States
Facility Name
Site Reference ID/Investigator# 72697
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60640
Country
United States
Facility Name
Site Reference ID/Investigator# 76533
City
Hoffman Estates
State/Province
Illinois
ZIP/Postal Code
60169
Country
United States
Facility Name
Site Reference ID/Investigator# 75056
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67214
Country
United States
Facility Name
Site Reference ID/Investigator# 72694
City
Cedarhurst
State/Province
New York
ZIP/Postal Code
11516
Country
United States
Facility Name
Site Reference ID/Investigator# 75137
City
Rochester
State/Province
New York
ZIP/Postal Code
14623
Country
United States
Facility Name
Site Reference ID/Investigator# 75053
City
Staten Island
State/Province
New York
ZIP/Postal Code
10312
Country
United States
Facility Name
Site Reference ID/Investigator# 75413
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19139
Country
United States
Facility Name
Site Reference ID/Investigator# 74553
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231
Country
United States
Facility Name
Site Reference ID/Investigator# 72696
City
DeSoto
State/Province
Texas
ZIP/Postal Code
75115
Country
United States
Facility Name
Site Reference ID/Investigator# 75055
City
Houston
State/Province
Texas
ZIP/Postal Code
77008
Country
United States
Facility Name
Site Reference ID/Investigator# 74896
City
Houston
State/Province
Texas
ZIP/Postal Code
77098
Country
United States
Facility Name
Site Reference ID/Investigator# 94476
City
Chita
ZIP/Postal Code
672090
Country
Russian Federation
Facility Name
Site Reference ID/Investigator# 79515
City
Ekaterinburg
ZIP/Postal Code
620030
Country
Russian Federation
Facility Name
Site Reference ID/Investigator# 94528
City
Kazan
ZIP/Postal Code
420061
Country
Russian Federation
Facility Name
Site Reference ID/Investigator# 79517
City
Lipetsk
ZIP/Postal Code
399083
Country
Russian Federation
Facility Name
Site Reference ID/Investigator# 81934
City
Moscow
ZIP/Postal Code
107076
Country
Russian Federation
Facility Name
Site Reference ID/Investigator# 81935
City
Moscow
ZIP/Postal Code
109559
Country
Russian Federation
Facility Name
Site Reference ID/Investigator# 79516
City
Moscow
ZIP/Postal Code
115419
Country
Russian Federation
Facility Name
Site Reference ID/Investigator# 83116
City
Novosibirsk
ZIP/Postal Code
630064
Country
Russian Federation
Facility Name
Site Reference ID/Investigator# 97136
City
Saint-Petersburg
ZIP/Postal Code
195176
Country
Russian Federation
Facility Name
Site Reference ID/Investigator# 81933
City
Saratov
ZIP/Postal Code
410028
Country
Russian Federation
Facility Name
Site Reference ID/Investigator# 79514
City
Saratov
ZIP/Postal Code
410060
Country
Russian Federation
Facility Name
Site Reference ID/Investigator# 80673
City
St. Petersburg
ZIP/Postal Code
190020
Country
Russian Federation
Facility Name
Site Reference ID/Investigator# 85093
City
St. Petersburg
ZIP/Postal Code
190121
Country
Russian Federation
Facility Name
Site Reference ID/Investigator# 97135
City
St. Petersburg
ZIP/Postal Code
191119
Country
Russian Federation
Facility Name
Site Reference ID/Investigator# 97137
City
St. Petersburg
ZIP/Postal Code
191119
Country
Russian Federation
Facility Name
Site Reference ID/Investigator# 83115
City
St. Petersburg
ZIP/Postal Code
192019
Country
Russian Federation
Facility Name
Site Reference ID/Investigator# 84733
City
St. Petersburg
ZIP/Postal Code
197341
Country
Russian Federation
Facility Name
Site Reference ID/Investigator# 79520
City
Stavropol
ZIP/Postal Code
357034
Country
Russian Federation
Facility Name
Site Reference ID/Investigator# 83117
City
Yaroslavl
ZIP/Postal Code
150003
Country
Russian Federation
Facility Name
Site Reference ID/Investigator# 97138
City
Yekaterinburg
ZIP/Postal Code
620028
Country
Russian Federation
Facility Name
Site Reference ID/Investigator# 81938
City
Brentford
ZIP/Postal Code
TW8 8DS
Country
United Kingdom
Facility Name
Site Reference ID/Investigator# 81940
City
Edinburgh
ZIP/Postal Code
EH10 5HF
Country
United Kingdom
Facility Name
Site Reference ID/Investigator# 81939
City
London
ZIP/Postal Code
SE5 8AF
Country
United Kingdom
Facility Name
Site Reference ID/Investigator# 92813
City
London
ZIP/Postal Code
W6 8RP
Country
United Kingdom
Facility Name
Site Reference ID/Investigator# 81937
City
Newcastle upon Tyne
ZIP/Postal Code
NE4 5PL
Country
United Kingdom
Facility Name
Site Reference ID/Investigator# 81943
City
Oxford
ZIP/Postal Code
OX3 7JX
Country
United Kingdom
Facility Name
Site Reference ID/Investigator# 82238
City
Preston
ZIP/Postal Code
PR5 6YA
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
27319970
Citation
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.
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
PubMed Identifier
28223265
Citation
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.
Results Reference
derived

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

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