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Trial record 1 of 1 for:    NCT01161472
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A Study to Assess the Cognitive Effects of Fesoterodine in Elderly Subjects

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ClinicalTrials.gov Identifier: NCT01161472
Recruitment Status : Completed
First Posted : July 13, 2010
Results First Posted : June 28, 2012
Last Update Posted : June 28, 2012
Sponsor:
Information provided by (Responsible Party):
Pfizer

Tracking Information
First Submitted Date  ICMJE July 12, 2010
First Posted Date  ICMJE July 13, 2010
Results First Submitted Date  ICMJE May 25, 2012
Results First Posted Date  ICMJE June 28, 2012
Last Update Posted Date June 28, 2012
Study Start Date  ICMJE July 2010
Actual Primary Completion Date September 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 25, 2012)
  • Computer Based Objective Cognition Testing (CogState) Detection Speed [ Time Frame: Baseline ]
    Detection speed: a cognitive test which assessed psychomotor function. A playing card was presented face up in the center of the screen. As soon as this happened, the participant was to press the 'Yes' key. The outcome measure was speed of performance; mean of the log10 transformed reaction time for correct responses [measured in log10 milliseconds (MS)]. Lower scores meant a better performance.
  • Change From Baseline in Computer Based Objective Cognition Testing (CogState) Detection Speed on Day 6 [ Time Frame: Baseline and Day 6 ]
    Detection speed: a cognitive test which assessed psychomotor function. A playing card was presented face up in the center of the screen. As soon as this happened, the participant was to press the 'Yes' key. The outcome measure was speed of performance; mean of the log10 transformed reaction time for correct responses [measured in log10 milliseconds (MS)]. Lower scores meant a better performance.
Original Primary Outcome Measures  ICMJE
 (submitted: July 12, 2010)
Psychomotor function (Log10 milliseconds) [ Time Frame: 6 days ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 25, 2012)
  • CogState Identification Speed [ Time Frame: Baseline ]
    Identification speed: a cognitive test which assessed visual attention. A playing card was presented face up in the center of the screen. As soon as this happened, the participant had to decide whether the card was red or not. The outcome measure was speed of performance; mean of the log10 transformed reaction time for correct responses (measured in log10 MS). Lower scores meant a better performance.
  • Change From Baseline in CogState Identification Speed on Day 6 [ Time Frame: Baseline and Day 6 ]
    Identification speed: a cognitive test which assessed visual attention. A playing card was presented face up in the center of the screen. As soon as this happened, the participant had to decide whether the card was red or not. The outcome measure was speed of performance; mean of the log10 transformed reaction time for correct responses (measured in log10 MS). Lower scores meant a better performance.
  • CogState One Card Learning [ Time Frame: Baseline ]
    One card learning: a cognitive test which assessed visual learning. Participants were to remember which cards were previously shown in a task. The outcome measure was accuracy of performance; arcsine transformation of the square root (sqrt) of the proportion of correct responses. Higher scores meant a better performance.
  • Change From Baseline in CogState One Card Learning on Day 6 [ Time Frame: Baseline and Day 6 ]
    One card learning: a cognitive test which assessed visual learning. Participants were to remember which cards were previously shown in a task. The outcome measure was accuracy of performance; arcsine transformation of the square root (sqrt) of the proportion of correct responses. Higher scores meant a better performance.
  • CogState Continuous Paired Associate Learning (CPAL) [ Time Frame: Baseline ]
    CPAL: a cognitive test which assessed visual episodic learning. Participant was to learn and remember picture locations on the screen and was to tap the target on the central location to begin. As each picture was revealed, the participant was to remember where the picture was located and tap that location. The outcome measure was the number of errors made in correctly placing each of the 4 patterns in their location 4 times. Lower scores meant a better performance.
  • Change From Baseline in CogState CPAL on Day 6 [ Time Frame: Baseline and Day 6 ]
    CPAL: a cognitive test which assessed visual episodic learning. Participant was to learn and remember picture locations on the screen and was to tap the target on the central location to begin. As each picture was revealed, the participant was to remember where the picture was located and tap that location. The outcome measure was the number of errors made in correctly placing each of the 4 patterns in their location 4 times. Lower scores meant a better performance.
  • CogState Groton Maze Learning Task (GMLT) [ Time Frame: Baseline ]
    GMLT: a cognitive test which assessed executive function. Participant was shown a 10 x 10 grid of tiles on a computer touch screen. A 28-step pathway was hidden among 100 possible locations. The participant was instructed to move 1 step from the start location and then continue 1 tile at a time, toward the end to find the pathway. The outcome measure was total number of errors made in attempting to learn the same hidden pathway on 5 consecutive trials at a single session. Lower scores meant a better performance.
  • Change From Baseline in CogState Groton Maze Learning Task on Day 6 [ Time Frame: Baseline and Day 6 ]
    GMLT: a cognitive test which assessed executive function. Participant was shown a 10 x 10 grid of tiles on a computer touch screen. A 28-step pathway was hidden among 100 possible locations. The participant was instructed to move 1 step from the start location and then continue 1 tile at a time, toward the end to find the pathway. The outcome measure was total number of errors made in attempting to learn the same hidden pathway on 5 consecutive trials at a single session. Lower scores meant a better performance.
  • Rey Auditory Verbal Learning Test (RAVLT) [ Time Frame: Baseline ]
    RAVLT evaluates a wide diversity of functions: short-term auditory-verbal memory, rate of learning, learning strategies, retroactive, and proactive interference, presence of confabulation of confusion in memory processes, retention of information, and differences between learning and retrieval. Assessment of RAVLT is between 10 to 15 minutes; Performance variable: the sum of the number of words recalled successfully on the delayed recall trial. Higher score meant a better performance.
  • Rey Auditory Verbal Learning Test (RAVLT) on Day 6 [ Time Frame: Baseline and Day 6 ]
    RAVLT evaluates a wide diversity of functions: short-term auditory-verbal memory, rate of learning, learning strategies, retroactive, and proactive interference, presence of confabulation of confusion in memory processes, retention of information, and differences between learning and retrieval. Assessment of RAVLT is between 10 to 15 minutes; Performance variable: the sum of the number of words recalled successfully on the delayed recall trial. Higher score meant a better performance.
Original Secondary Outcome Measures  ICMJE
 (submitted: July 12, 2010)
  • Attention (Arcsine proportion correct) [ Time Frame: 6 days ]
  • Visual episodic memory (number of errors) [ Time Frame: 6 days ]
  • Groton Maze Learning Task- (Number of errors) [ Time Frame: 6 days ]
  • Rey Auditory Verbal Learning Test (number of words recalled) [ Time Frame: 6 days ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study to Assess the Cognitive Effects of Fesoterodine in Elderly Subjects
Official Title  ICMJE A 4 Way Placebo And Active Controlled Study To Evaluate The Effects Of Fesoterodine On Cognitive Function In Healthy Elderly Subjects
Brief Summary The study is designed to evaluate elements of cognitive function in subjects receiving either fesoterodine or alprazolam.
Detailed Description Evaluation of cognitive function
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Condition  ICMJE Healthy
Intervention  ICMJE
  • Drug: 4mg fesoterodine
    4mg tablet once daily for 6 days
  • Drug: 8mg fesoterodine
    4mg tablet once daily for 3 days followed by 8mg tablet once daily for 3 days
  • Drug: alprazolam 1mg
    1mg tablet once on last day of treatment period at clinic
  • Drug: Placebo
    Placebo tablet for fesoterodine once daily for 6 days and placebo tablet for alprazolam once on last day of treatment period at clinic
Study Arms  ICMJE
  • Experimental: 4mg fesoterodine
    Intervention: Drug: 4mg fesoterodine
  • Experimental: fesoterodine 8mg
    Intervention: Drug: 8mg fesoterodine
  • Active Comparator: 1mg alprazolam
    Intervention: Drug: alprazolam 1mg
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 12, 2010)
20
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE September 2010
Actual Primary Completion Date September 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Adult healthy volunteers 65 years and over with minimum MMSE of 26

Exclusion Criteria:

  • Prohibited concomitant medications
  • Confounding medical conditions
  • Clinically significant comorbid diseases
  • Hypersensitivity or contraindications to fesoterodine or active control
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 65 Years to 85 Years   (Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01161472
Other Study ID Numbers  ICMJE A0221086
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date May 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP