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

• 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: Pfizer
• Information provided by (Responsible Party): Pfizer

Study Description

Brief Summary:

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

Condition or disease	Intervention/treatment	Phase
Healthy	Drug: 4mg fesoterodine; Drug: 8mg fesoterodine; Drug: alprazolam 1mg; Drug: Placebo	Phase 1

Detailed Description:

Evaluation of cognitive function

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 20 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Quadruple (Participant, Care Provider, 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
• Study Start Date: July 2010
• Actual Primary Completion Date: September 2010
• Actual Study Completion Date: September 2010

Arms and Interventions

Arm	Intervention/treatment
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

Outcome Measures

Primary Outcome Measures :

1. 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.
2. 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.

Secondary Outcome Measures :

1. 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.
2. 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.
3. 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.
4. 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.
5. 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.
6. 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.
7. 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.
8. 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.
9. 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.
10. 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.

Eligibility Criteria

• Ages Eligible for Study: 65 Years to 85 Years (Older Adult)
• Sexes Eligible for Study: All
• 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

Locations

United States, Kansas

Pfizer Investigational Site

Overland Park, Kansas, United States, 66211

Pfizer Investigational Site

Overland Park, Kansas, United States, 66212

Sponsors and Collaborators

Pfizer

Investigators

• Study Director: Pfizer CT.gov Call Center; Pfizer

More Information

Additional Information:

To obtain contact information for a study center near you, click here. 

• Responsible Party: Pfizer
• ClinicalTrials.gov Identifier: NCT01161472
• Other Study ID Numbers: A0221086
• First Posted: July 13, 2010
• Results First Posted: June 28, 2012
• Last Update Posted: June 28, 2012
• Last Verified: May 2012

Additional relevant MeSH terms:

Alprazolam; Fesoterodine; Hypnotics and Sedatives; Central Nervous System Depressants; Physiological Effects of Drugs; Anti-Anxiety Agents; Tranquilizing Agents; Psychotropic Drugs; GABA Modulators; GABA Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Muscarinic Antagonists; Cholinergic Antagonists; Cholinergic Agents; Urological Agents