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| ID | Type | Description | Link |
|---|---|---|---|
| 2012-000418-13 | EudraCT Number |
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This is a safety and efficacy study evaluating a experimental treatment for cognitive deficits in adults with schizophrenia.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ABT-126 Low Dose | Experimental | ABT-126 Low Dose |
|
| ABT-126 Middle Dose | Experimental | ABT-126 Middle 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 Middle Dose |
| |
| ABT-126 |
| Measure | Description | Time Frame |
|---|---|---|
| Cognition: MCCB (MATRICS Consensus Cognitive Battery) | Rater based interview | Change from baseline to week 24 |
| 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 24 |
| Symptom Severity: PANSS (Positive and Negative Symptom 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# 75139 | Anaheim | California | 92804 | United States | ||
| Site Reference ID/Investigator# 74894 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27319970 | Result | 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. | |
| 28433500 | Derived |
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| Drug |
ABT-126 Low Dose |
|
| ABT-126 | Drug | ABT-126 High Dose |
|
| Placebo | Drug | Placebo |
|
Rater based interview
| Measurements from screening period up through week 24 |
| Symptom Severity: NSA-16 (16-item version of the Negative Symptom Assessment Scale) | Rater based interview | Measurements from screening period up through week 24 |
| Bellflower |
| California |
| 90706 |
| United States |
| Site Reference ID/Investigator# 74434 | Chino | California | 91710 | United States |
| Site Reference ID/Investigator# 76593 | Costa Mesa | California | 92626 | United States |
| Site Reference ID/Investigator# 73213 | Escondido | California | 92025 | United States |
| Site Reference ID/Investigator# 72698 | Garden Grove | California | 92845 | United States |
| Site Reference ID/Investigator# 75057 | La Habra | California | 90631 | United States |
| Site Reference ID/Investigator# 72693 | National City | California | 91950 | United States |
| Site Reference ID/Investigator# 77655 | Norwalk | California | 90650 | United States |
| Site Reference ID/Investigator# 74895 | Oakland | California | 94612 | United States |
| Site Reference ID/Investigator# 73977 | Oceanside | California | 92056 | United States |
| Site Reference ID/Investigator# 73214 | Orange | California | 92868 | United States |
| Site Reference ID/Investigator# 74453 | Pico Rivera | California | 90660 | United States |
| Site Reference ID/Investigator# 74898 | Riverside | California | 92506 | United States |
| Site Reference ID/Investigator# 98016 | San Bernardino | California | 92408 | United States |
| Site Reference ID/Investigator# 86973 | San Diego | California | 92102 | United States |
| Site Reference ID/Investigator# 75140 | San Diego | California | 92103 | United States |
| Site Reference ID/Investigator# 73974 | San Gabriel | California | 91776 | United States |
| Site Reference ID/Investigator# 74433 | Santa Ana | California | 92705 | United States |
| Site Reference ID/Investigator# 72695 | Torrance | California | 90502 | United States |
| Site Reference ID/Investigator# 75136 | New Haven | Connecticut | 06519 | United States |
| Site Reference ID/Investigator# 75653 | Atlanta | Georgia | 30308 | United States |
| Site Reference ID/Investigator# 74893 | Marietta | Georgia | 30060 | United States |
| Site Reference ID/Investigator# 72697 | Chicago | Illinois | 60640 | United States |
| Site Reference ID/Investigator# 76533 | Hoffman Estates | Illinois | 60169 | United States |
| Site Reference ID/Investigator# 75056 | Wichita | Kansas | 67214 | United States |
| Site Reference ID/Investigator# 72694 | Cedarhurst | New York | 11516 | United States |
| Site Reference ID/Investigator# 75137 | Rochester | New York | 14623 | United States |
| Site Reference ID/Investigator# 75053 | Staten Island | New York | 10312 | United States |
| Site Reference ID/Investigator# 75413 | Philadelphia | Pennsylvania | 19139 | United States |
| Site Reference ID/Investigator# 74553 | Dallas | Texas | 75231 | United States |
| Site Reference ID/Investigator# 72696 | DeSoto | Texas | 75115 | United States |
| Site Reference ID/Investigator# 75055 | Houston | Texas | 77008 | United States |
| Site Reference ID/Investigator# 74896 | Houston | Texas | 77098 | United States |
| Site Reference ID/Investigator# 94476 | Chita | 672090 | Russia |
| Site Reference ID/Investigator# 94528 | Kazan' | 420061 | Russia |
| Site Reference ID/Investigator# 79517 | Lipetsk | 399083 | Russia |
| Site Reference ID/Investigator# 81934 | Moscow | 107076 | Russia |
| Site Reference ID/Investigator# 81935 | Moscow | 109559 | Russia |
| Site Reference ID/Investigator# 79516 | Moscow | 115419 | Russia |
| Site Reference ID/Investigator# 83116 | Novosibirsk | 630064 | Russia |
| Site Reference ID/Investigator# 80673 | Saint Petersburg | 190020 | Russia |
| Site Reference ID/Investigator# 85093 | Saint Petersburg | 190121 | Russia |
| Site Reference ID/Investigator# 97135 | Saint Petersburg | 191119 | Russia |
| Site Reference ID/Investigator# 97137 | Saint Petersburg | 191119 | Russia |
| Site Reference ID/Investigator# 83115 | Saint Petersburg | 192019 | Russia |
| Site Reference ID/Investigator# 97136 | Saint Petersburg | 195176 | Russia |
| Site Reference ID/Investigator# 84733 | Saint Petersburg | 197341 | Russia |
| Site Reference ID/Investigator# 81933 | Saratov | 410028 | Russia |
| Site Reference ID/Investigator# 79514 | Saratov | 410060 | Russia |
| Site Reference ID/Investigator# 79520 | Stavropol | 357034 | Russia |
| Site Reference ID/Investigator# 83117 | Yaroslavl | 150003 | Russia |
| Site Reference ID/Investigator# 97138 | Yekaterinburg | 620028 | Russia |
| Site Reference ID/Investigator# 79515 | Yekaterinburg | 620030 | Russia |
| Site Reference ID/Investigator# 81938 | Brentford | TW8 8DS | United Kingdom |
| Site Reference ID/Investigator# 81940 | Edinburgh | EH10 5HF | United Kingdom |
| Site Reference ID/Investigator# 81939 | London | SE5 8AF | United Kingdom |
| Site Reference ID/Investigator# 92813 | London | W6 8RP | United Kingdom |
| Site Reference ID/Investigator# 81937 | Newcastle upon Tyne | NE4 5PL | United Kingdom |
| Site Reference ID/Investigator# 81943 | Oxford | OX3 7JX | United Kingdom |
| Site Reference ID/Investigator# 82238 | Preston | PR5 6YA | United Kingdom |
| 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. |
| 28223265 | Derived | 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. |
| 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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