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This is an efficacy and safety study evaluating an experimental treatment for cognitive deficits in adults with schizophrenia.
This is a Phase 2 study designed to evaluate the efficacy and safety of ABT-126 in approximately 210 adults with schizophrenia. Subjects will be randomized to one of three treatment groups (ABT-126 Dose 1, ABT-126 Dose 2 or placebo) for a 12-week Treatment Period. The purpose of this research study is to find out whether ABT-126 compared to placebo can improve cognition and what side effects ABT-126 may cause. Cognition is the way a person thinks, and it includes abilities like paying attention, focusing, remembering things, and solving problems. Acronyms listed in the Outcomes and/or Eligibility sections for this study are defined below: • MCCB: Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery • UPSA-2: University of California at San Diego (UCSD) Performance-Based Skills Assessment-2 • CANTAB: Cambridge Neuropsychological Test Automated Battery • PANSS: Positive and Negative Syndrome Scale • NSA-16: Negative Symptom Assessment-16 • CGI-S: Clinical Global Impression - Severity
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ABT-126 Dose 1 | Experimental |
| |
| ABT-126 Dose 2 | Experimental |
| |
| Sugar Pill | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ABT-126 | Drug | ABT-126 Dose 1, ABT-126 Dose 2 |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Cognition: MCCB | Measurements from screening period through 12-week treatment period |
| Measure | Description | Time Frame |
|---|---|---|
| Functioning: UPSA-2 | Measurements from screening period through 12-week treatment period | |
| Cognition: CANTAB | Measurements from screening period through 12-week treatment period | |
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Inclusion Criteria
Exclusion Criteria
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| Name | Affiliation | Role |
|---|---|---|
| George Haig, PharmD | AbbVie | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Site Reference ID/Investigator# 26267 | Cerritos | California | 90703 | United States | ||
| Site Reference ID/Investigator# 45320 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26044974 | Background | Hashimoto K. Targeting of alpha7 Nicotinic Acetylcholine Receptors in the Treatment of Schizophrenia and the Use of Auditory Sensory Gating as a Translational Biomarker. Curr Pharm Des. 2015;21(26):3797-806. doi: 10.2174/1381612821666150605111345. | |
| 28433500 | Derived | 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. |
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| Placebo |
| Drug |
Placebo |
|
| Symptom Severity: PANSS, NSA-16, CGI-S |
| Measurements from screening period through 12-week treatment period |
| Costa Mesa |
| California |
| 92626 |
| United States |
| Site Reference ID/Investigator# 27068 | Escondido | California | 92025 | United States |
| Site Reference ID/Investigator# 52568 | Garden Grove | California | 92845 | United States |
| Site Reference ID/Investigator# 26266 | Granada Hills | California | 91344 | United States |
| Site Reference ID/Investigator# 26388 | Oceanside | California | 92056 | United States |
| Site Reference ID/Investigator# 45315 | San Bernardino | California | 92408 | United States |
| Site Reference ID/Investigator# 26271 | San Diego | California | 92102 | United States |
| Site Reference ID/Investigator# 27045 | Santa Ana | California | 92701 | United States |
| Site Reference ID/Investigator# 45314 | Santa Ana | California | 92705 | United States |
| Site Reference ID/Investigator# 26264 | Torrance | California | 90502 | United States |
| Site Reference ID/Investigator# 27072 | Tampa | Florida | 33613 | United States |
| Site Reference ID/Investigator# 27043 | Wichita | Kansas | 67214 | United States |
| Site Reference ID/Investigator# 26395 | Lake Charles | Louisiana | 70629 | United States |
| Site Reference ID/Investigator# 26268 | St Louis | Missouri | 63118 | United States |
| Site Reference ID/Investigator# 26392 | Fresh Meadows | New York | 11366 | United States |
| Site Reference ID/Investigator# 27073 | New York | New York | 10065 | United States |
| Site Reference ID/Investigator# 26262 | Rochester | New York | 14618 | United States |
| Site Reference ID/Investigator# 27071 | Beachwood | Ohio | 44122 | United States |
| Site Reference ID/Investigator# 36020 | Media | Pennsylvania | 19063 | United States |
| Site Reference ID/Investigator# 28063 | Norristown | Pennsylvania | 19401 | United States |
| Site Reference ID/Investigator# 27070 | Sellersville | Pennsylvania | 18960 | United States |
| Site Reference ID/Investigator# 27069 | Dallas | Texas | 75243 | United States |
| ID | Term |
|---|---|
| C000618299 | ABT-126 |
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