A Study to Assess the Cognitive Effects of Fesoterodine in Elderly Subjects

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01161472
First received: July 12, 2010
Last updated: May 25, 2012
Last verified: May 2012
  Purpose

The study is designed to evaluate elements of cognitive function in subjects receiving either fesoterodine or alprazolam.


Condition Intervention Phase
Healthy
Drug: 4mg fesoterodine
Drug: 8mg fesoterodine
Drug: alprazolam 1mg
Drug: Placebo
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Official Title: A 4 Way Placebo And Active Controlled Study To Evaluate The Effects Of Fesoterodine On Cognitive Function In Healthy Elderly Subjects

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Computer Based Objective Cognition Testing (CogState) Detection Speed [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • CogState Identification Speed [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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.


Enrollment: 20
Study Start Date: July 2010
Study Completion Date: September 2010
Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 4mg fesoterodine Drug: 4mg fesoterodine
4mg tablet once daily for 6 days
Experimental: fesoterodine 8mg Drug: 8mg fesoterodine
4mg tablet once daily for 3 days followed by 8mg tablet once daily for 3 days
Active Comparator: 1mg alprazolam Drug: alprazolam 1mg
1mg tablet once on last day of treatment period at clinic
Placebo Comparator: Placebo 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

Detailed Description:

Evaluation of cognitive function

  Eligibility

Ages Eligible for Study:   65 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01161472

Locations
United States, Kansas
Pfizer Investigational Site
Overland Park, Kansas, United States, 66212
Pfizer Investigational Site
Overland Park, Kansas, United States, 66211
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01161472     History of Changes
Other Study ID Numbers: A0221086
Study First Received: July 12, 2010
Results First Received: May 25, 2012
Last Updated: May 25, 2012
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Alprazolam
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Anti-Anxiety Agents
Tranquilizing Agents
Psychotropic Drugs
GABA Modulators
GABA Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on July 23, 2014