Add On Treatment for Cognitive Deficits in Schizophrenia
This study will look at the impact of dosing as well as ongoing treatment with an investigation medication identified as PF-03654746, on cognitive and physiologic indicators of brain function. Data from this study will assist with the evaluation of the utility of functional magnetic resonance imaging, arterial spin labeling (ASL), and electrophysiologic measures in the detection of early signals of the effectiveness of medications developed to target cognitive impairment in schizophrenia. Safety and tolerability of PF-03654746 in this population will be also be evaluated.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||A Phase1B Study: A Placebo Controlled Study of PF-03654746 Given as Add-On Treatment of Cognitive Deficits in Schizophrenia|
- MATRICS Consensus Cognitive Battery [ Time Frame: 13 - 15 Weeks ] [ Designated as safety issue: No ]
- ASL perfusion and performance on neurocognitive measures [ Time Frame: 3 Weeks ] [ Designated as safety issue: No ]
- fMRI activation parameters and performance on neurocognitive measures. [ Time Frame: 3 weeks ] [ Designated as safety issue: No ]
- ERP measures and performance on neurocognitive measures [ Time Frame: 3 Weeks ] [ Designated as safety issue: No ]
|Study Start Date:||April 2009|
|Study Completion Date:||November 2010|
|Primary Completion Date:||November 2010 (Final data collection date for primary outcome measure)|
Active Comparator: PF-03654746
H3 receptor antagonist currently being developed for the treatment of cognitive impairment associated with schizophrenia (CIAS) as well as with Alzheimer's disease.
Drug: PF 03654746
All participants will receive 3 weeks of PF-03654746 and 3 weeks of placebo. PF-03654746 and placebo will be administered in a flexible titration regimen, beginning with 0.5 mg/d. If 0.5 mg/d is well tolerated, the dose will be increased to 1.0 mg/d after 5 days. If 1.0 mg/d is not well tolerated, the dose will be decreased to 0.5 mg/d, with the goal of achieving a stable dose of PF-03654746 within the first two weeks of dosing and avoiding further dose changes during the final week of dosing.
|Placebo Comparator: Placebo||
Placebo will be used as a comparator to the active arm.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01346163
|United States, Pennsylvania|
|University of Pennsylvania|
|Philadelphia, Pennsylvania, United States, 19104|
|Principal Investigator:||Raquel P. Gur, M.D., Ph.D.||University of Pennsylvania|