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

NCT01655680 | Completed Phase 2 DMC

• 2 other identifiers: M10-8552012-000418-13
• Study Type: interventional
• Target: 432
• Locations: 3 countries
• Sites: 61

Brief Summary

This is a safety and efficacy study evaluating a experimental treatment for cognitive deficits in adults with schizophrenia.

Conditions

Schizophrenia

Keywords

Schizophrenia

Outcome Measures

Primary Outcomes (1)

• Cognition: MCCB (MATRICS Consensus Cognitive Battery)

  Rater based interview

  Change from baseline to week 24

Secondary Outcomes (3)

• Functioning: UPSA-2 (University of California San Diego Performance-based Skills Assessment-2)

  Measurements from screening period up through week 24

• Symptom Severity: PANSS (Positive and Negative Symptom Scale)

  Measurements from screening period up through week 24

• Symptom Severity: NSA-16 (16-item version of the Negative Symptom Assessment Scale)

  Measurements from screening period up through week 24

Study Arms (4)

ABT-126 Low Dose

EXPERIMENTAL

ABT-126 Low Dose

Drug: ABT-126

ABT-126 Middle Dose

EXPERIMENTAL

ABT-126 Middle Dose

Drug: ABT-126

ABT-126 High Dose

EXPERIMENTAL

ABT-126 High Dose

Drug: ABT-126

Placebo

PLACEBO COMPARATOR

Placebo

Drug: Placebo

Interventions

ABT-126 DRUG

ABT-126 Middle Dose

ABT-126 Middle Dose

Placebo DRUG

Placebo

Placebo

Eligibility Criteria

• Age: 20 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• AbbVie (prior sponsor, Abbott): lead

Study Sites (61)

Site Reference ID/Investigator# 75139

Anaheim, California, 92804, United States

Location

Site Reference ID/Investigator# 74894

Bellflower, California, 90706, United States

Location

Site Reference ID/Investigator# 74434

Chino, California, 91710, United States

Location

Site Reference ID/Investigator# 76593

Costa Mesa, California, 92626, United States

Location

Site Reference ID/Investigator# 73213

Escondido, California, 92025, United States

Location

Site Reference ID/Investigator# 72698

Garden Grove, California, 92845, United States

Location

Site Reference ID/Investigator# 75057

La Habra, California, 90631, United States

Location

Site Reference ID/Investigator# 72693

National City, California, 91950, United States

Location

Site Reference ID/Investigator# 77655

Norwalk, California, 90650, United States

Location

Site Reference ID/Investigator# 74895

Oakland, California, 94612, United States

Location

Site Reference ID/Investigator# 73977

Oceanside, California, 92056, United States

Location

Site Reference ID/Investigator# 73214

Orange, California, 92868, United States

Location

Site Reference ID/Investigator# 74453

Pico Rivera, California, 90660, United States

Location

Site Reference ID/Investigator# 74898

Riverside, California, 92506, United States

Location

Site Reference ID/Investigator# 98016

San Bernardino, California, 92408, United States

Location

Site Reference ID/Investigator# 86973

San Diego, California, 92102, United States

Location

Site Reference ID/Investigator# 75140

San Diego, California, 92103, United States

Location

Site Reference ID/Investigator# 73974

San Gabriel, California, 91776, United States

Location

Site Reference ID/Investigator# 74433

Santa Ana, California, 92705, United States

Location

Site Reference ID/Investigator# 72695

Torrance, California, 90502, United States

Location

Site Reference ID/Investigator# 75136

New Haven, Connecticut, 06519, United States

Location

Site Reference ID/Investigator# 75653

Atlanta, Georgia, 30308, United States

Location

Site Reference ID/Investigator# 74893

Marietta, Georgia, 30060, United States

Location

Site Reference ID/Investigator# 72697

Chicago, Illinois, 60640, United States

Location

Site Reference ID/Investigator# 76533

Hoffman Estates, Illinois, 60169, United States

Location

Site Reference ID/Investigator# 75056

Wichita, Kansas, 67214, United States

Location

Site Reference ID/Investigator# 72694

Cedarhurst, New York, 11516, United States

Location

Site Reference ID/Investigator# 75137

Rochester, New York, 14623, United States

Location

Site Reference ID/Investigator# 75053

Staten Island, New York, 10312, United States

Location

Site Reference ID/Investigator# 75413

Philadelphia, Pennsylvania, 19139, United States

Location

Site Reference ID/Investigator# 74553

Dallas, Texas, 75231, United States

Location

Site Reference ID/Investigator# 72696

DeSoto, Texas, 75115, United States

Location

Site Reference ID/Investigator# 75055

Houston, Texas, 77008, United States

Location

Site Reference ID/Investigator# 74896

Houston, Texas, 77098, United States

Location

Site Reference ID/Investigator# 94476

Chita, 672090, Russia

Location

Site Reference ID/Investigator# 94528

Kazan', 420061, Russia

Location

Site Reference ID/Investigator# 79517

Lipetsk, 399083, Russia

Location

Site Reference ID/Investigator# 81934

Moscow, 107076, Russia

Location

Site Reference ID/Investigator# 81935

Moscow, 109559, Russia

Location

Site Reference ID/Investigator# 79516

Moscow, 115419, Russia

Location

Site Reference ID/Investigator# 83116

Novosibirsk, 630064, Russia

Location

Site Reference ID/Investigator# 80673

Saint Petersburg, 190020, Russia

Location

Site Reference ID/Investigator# 85093

Saint Petersburg, 190121, Russia

Location

Site Reference ID/Investigator# 97135

Saint Petersburg, 191119, Russia

Location

Site Reference ID/Investigator# 97137

Saint Petersburg, 191119, Russia

Location

Site Reference ID/Investigator# 83115

Saint Petersburg, 192019, Russia

Location

Site Reference ID/Investigator# 97136

Saint Petersburg, 195176, Russia

Location

Site Reference ID/Investigator# 84733

Saint Petersburg, 197341, Russia

Location

Site Reference ID/Investigator# 81933

Saratov, 410028, Russia

Location

Site Reference ID/Investigator# 79514

Saratov, 410060, Russia

Location

Site Reference ID/Investigator# 79520

Stavropol, 357034, Russia

Location

Site Reference ID/Investigator# 83117

Yaroslavl, 150003, Russia

Location

Site Reference ID/Investigator# 97138

Yekaterinburg, 620028, Russia

Location

Site Reference ID/Investigator# 79515

Yekaterinburg, 620030, Russia

Location

Site Reference ID/Investigator# 81938

Brentford, TW8 8DS, United Kingdom

Location

Site Reference ID/Investigator# 81940

Edinburgh, EH10 5HF, United Kingdom

Location

Site Reference ID/Investigator# 81939

London, SE5 8AF, United Kingdom

Location

Site Reference ID/Investigator# 92813

London, W6 8RP, United Kingdom

Location

Site Reference ID/Investigator# 81937

Newcastle upon Tyne, NE4 5PL, United Kingdom

Location

Site Reference ID/Investigator# 81943

Oxford, OX3 7JX, United Kingdom

Location

Site Reference ID/Investigator# 82238

Preston, PR5 6YA, United Kingdom

Location

Related Publications (3)

• 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.

  PMID: 27319970 RESULT

• 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.

  PMID: 28433500 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.

  PMID: 28223265 DERIVED

MeSH Terms

Conditions

Schizophrenia

Interventions

ABT-126

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Study Officials

• George Haig, PharmD

  AbbVie

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 25, 2012
• First Posted: August 2, 2012
• Study Start: May 1, 2012
• Primary Completion: April 1, 2014
• Study Completion: July 1, 2014
• Last Updated: July 7, 2021

Record last verified: 2021-07

Locations

GB (7); US (34); RU (20)