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This is an efficacy study evaluating a experimental treatment for cognitive deficits in adults with schizophrenia.
Safety and Efficacy Study for Cognitive Deficits in Adult Subjects with Schizophrenia.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ABT-126 Low Dose | Experimental | ABT-126 Low Dose |
|
| ABT-126 High Dose | Experimental | ABT-126 High Dose |
|
| Placebo | Placebo Comparator | Placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ABT-126 | Drug | ABT-126 Low Dose |
| |
| ABT-126 |
| Measure | Description | Time Frame |
|---|---|---|
| Cognition: MCCB (MATRICS Consensus Cognitive Battery) change from baseline to week 12 | Rater based interview | Change from baseline to week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Functioning: UPSA-2 (University of California San Diego Performance-based Skills Assessment-2) | Rater based interview | Measurements from screening period up through week 12 |
| Symptom Severity: PANSS (Positive and Negative Syndrome Scale) |
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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# 74436 | Chino | California | 91710 | United States | ||
| Site Reference ID/Investigator# 72704 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28922590 | Result | 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. | |
| 28433500 |
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| Drug |
ABT-126 High Dose |
|
| Placebo | Drug | Placebo |
|
Rater based interview
| Measurements from screening period up through week 12 |
| Symptom Severity: NSA-16 (16-item version of the Negative Symptom Assessment Scale) | Rater based interview | Measurements from screening period up through week 12 |
| Garden Grove |
| California |
| 92845 |
| United States |
| Site Reference ID/Investigator# 72699 | National City | California | 91950 | United States |
| Site Reference ID/Investigator# 73983 | Oceanside | California | 92056 | United States |
| Site Reference ID/Investigator# 73236 | Orange | California | 92868 | United States |
| Site Reference ID/Investigator# 86974 | San Diego | California | 92102 | United States |
| Site Reference ID/Investigator# 72701 | Torrance | California | 90502 | United States |
| Site Reference ID/Investigator# 75314 | Bradenton | Florida | 34201 | United States |
| Site Reference ID/Investigator# 75146 | Maitland | Florida | 32751 | United States |
| Site Reference ID/Investigator# 75654 | Atlanta | Georgia | 30308 | United States |
| Site Reference ID/Investigator# 72703 | Chicago | Illinois | 60640 | United States |
| Site Reference ID/Investigator# 76534 | Hoffman Estates | Illinois | 60169 | United States |
| Site Reference ID/Investigator# 73984 | Lake Charles | Louisiana | 70629 | United States |
| Site Reference ID/Investigator# 73981 | St Louis | Missouri | 63109 | United States |
| Site Reference ID/Investigator# 89553 | Marlton | New Jersey | 08053 | United States |
| Site Reference ID/Investigator# 72700 | Cedarhurst | New York | 11516 | United States |
| Site Reference ID/Investigator# 73982 | New York | New York | 10065 | United States |
| Site Reference ID/Investigator# 113035 | Oklahoma City | Oklahoma | 73116 | United States |
| Site Reference ID/Investigator# 72702 | DeSoto | Texas | 75115 | United States |
| Site Reference ID/Investigator# 75147 | Houston | Texas | 77008 | United States |
| 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. |
| ID | Term |
|---|---|
| D012559 | Schizophrenia |
| ID | Term |
|---|---|
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| C000618299 | ABT-126 |
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