Part 1 of the study will assess the enhancement of task-related brain activation (BOLD response) in key brain areas in schizophrenia during the performance of working memory, episodic memory and visual activation tasks as measured by functional magnetic resonance imaging (fMRI) in people with schizophrenia. Part 2 of the study will assess the safety and tolerability of multiple doses of AQW051 in people with schizophrenia.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
68
West LA VA Healthcare Center (UCLA)
Los Angeles, California, United States
Department of Psychiatry & Behavioural Sciences, Feinberg School of Medicine (Northwestern University)
Chicago, Illinois, United States
Maryland Psychiatric Research Centre, Spring Grove Hospital Grounds
Baltimore, Maryland, United States
Part 1: Assess BOLD response in key brain areas in schizophrenia patients during the performance of tasks as measured by (fMRI) in people with schizophrenia.
Time frame: 2 years (Part 1: 1 year)
Part 2: Assess safety and tolerability of multiple doses of AQW051 schizophrenia patients.
Time frame: Part 2: 8 months
Measure: To assess the effects of a single dose of AQW051 on performance of working and episodic memory tasks in people with schizophrenia. (Part 1)
Time frame: Time Frame: 2 years (Part 1: 1 year; Part 2: 8 months)
Measure: To determine the relationship of exposure to brain activation after a single dose of AQW051 in people with schizophrenia. (Part 1)
Time frame: 2 years (Part 1: 1 year; Part 2: 8 months)
Measure: To determine the dose-exposure response relationship of multiple doses of AQW051 in people with schizophrenia. (Part 2)
Time frame: 2 years (Part 1: 1 year; Part 2: 8 months)
Measure: To explore effects of multiple doses of AQW051 on measures of cognition in people with schizophrenia. (Part 2)
Time frame: 2 years (Part 1: 1 year; Part 2: 8 months)
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Massachusetts General Hospital (Freedom Trail Clinic)
Boston, Massachusetts, United States
Washington University
St Louis, Missouri, United States
Columbia University
New York, New York, United States
JUH Clinical Research (Duke University),
Butner, North Carolina, United States