Healthy
Conditions
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
Interventions
DRUG4mg fesoterodine
4mg tablet once daily for 6 days
DRUG8mg fesoterodine
4mg tablet once daily for 3 days followed by 8mg tablet once daily for 3 days
DRUGalprazolam 1mg
1mg tablet once on last day of treatment period at clinic
DRUGPlacebo
Placebo tablet for fesoterodine once daily for 6 days and placebo tablet for alprazolam once on last day of treatment period at clinic
Sponsors
Pfizer
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
65 Years to 85 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Computer Based Objective Cognition Testing (CogState) Detection Speed | 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 | 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
| Measure | Time frame | Description |
|---|---|---|
| CogState One Card Learning | 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 | 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. |
| Change From Baseline in CogState CPAL on Day 6 | 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 Continuous Paired Associate Learning (CPAL) | 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. |
| CogState Identification Speed | 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 Groton Maze Learning Task on Day 6 | 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) | 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 | 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. |
| CogState Groton Maze Learning Task (GMLT) | 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 Identification Speed on Day 6 | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Entire Study Population All participants randomized to any treatment (fesoterodine 4 mg tablet first, fesoterodine 8 mg tablet first, alprazolam 1 mg capsule first and placebo first). | 20 |
| Total | 20 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Washout Period (At Least 3 to 6 Days) | Withdrawal by Subject | 1 | 0 | 0 | 0 |
Baseline characteristics
| Characteristic | Entire Study Population |
|---|---|
| Age Continuous | 72.2 Years STANDARD_DEVIATION 5.2 |
| Sex: Female, Male Female | 8 Participants |
| Sex: Female, Male Male | 12 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 6 / 20 | 11 / 19 | 18 / 19 | 7 / 20 |
| serious Total, serious adverse events | 0 / 20 | 0 / 19 | 0 / 19 | 0 / 20 |
Outcome results
Primary
Change From Baseline in Computer Based Objective Cognition Testing (CogState) Detection Speed on 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.
Time frame: Baseline and Day 6
Population: The PP Analysis Set included all randomized participants who completed the study, received treatment in all 4 study periods until the end of treatment visit in the fourth study period and who were not serious protocol violators. 'N' (Number of participants analyzed) signifies participants evaluable for the outcome measure.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Fesoterodine 4 mg | Change From Baseline in Computer Based Objective Cognition Testing (CogState) Detection Speed on Day 6 | -0.0201 Log10 MS | Standard Error 0.0153 |
| Fesoterodine 8 mg | Change From Baseline in Computer Based Objective Cognition Testing (CogState) Detection Speed on Day 6 | -0.0119 Log10 MS | Standard Error 0.015 |
| Aplrazolam 1 mg | Change From Baseline in Computer Based Objective Cognition Testing (CogState) Detection Speed on Day 6 | 0.0684 Log10 MS | Standard Error 0.015 |
| Placebo | Change From Baseline in Computer Based Objective Cognition Testing (CogState) Detection Speed on Day 6 | 0.0084 Log10 MS | Standard Error 0.0152 |
Comparison: Analysis of Covariance (ANCOVA) was used to determine p-value for comparison of fesoterodine 4 mg vs placebo, with model terms: period and treatment as the fixed effect, participants as the random effect, and between and within participant baselines as the covariates.p-value: 0.119895% CI: [-0.0647, 0.0077]ANCOVA
Comparison: ANCOVA was used to determine p-value for comparison of fesoterodine 8 mg vs placebo, with model terms: period and treatment as the fixed effect, participants as the random effect, and between and within participant baselines as the covariates.p-value: 0.245995% CI: [-0.0551, 0.0145]ANCOVA
Primary
Computer Based Objective Cognition Testing (CogState) Detection Speed
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.
Time frame: Baseline
Population: The Per Protocol (PP) Analysis Set included all randomized participants who completed the study, received treatment in all 4 study periods until the end of treatment visit in the fourth study period and who were not serious protocol violators. 'N' (Number of participants analyzed) signifies participants evaluable for the outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Fesoterodine 4 mg | Computer Based Objective Cognition Testing (CogState) Detection Speed | 2.6333 Log10 MS | Standard Deviation 0.1049 |
| Fesoterodine 8 mg | Computer Based Objective Cognition Testing (CogState) Detection Speed | 2.5971 Log10 MS | Standard Deviation 0.0937 |
| Aplrazolam 1 mg | Computer Based Objective Cognition Testing (CogState) Detection Speed | 2.6103 Log10 MS | Standard Deviation 0.1107 |
| Placebo | Computer Based Objective Cognition Testing (CogState) Detection Speed | 2.5842 Log10 MS | Standard Deviation 0.0875 |
Secondary
Change From Baseline in CogState CPAL on 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.
Time frame: Baseline and Day 6
Population: The PP Analysis Set included all randomized participants who completed the study, received treatment in all 4 study periods until the end of treatment visit in the fourth study period and who were not serious protocol violators. 'N' (Number of participants analyzed) signifies participants evaluable for the outcome measure.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Fesoterodine 4 mg | Change From Baseline in CogState CPAL on Day 6 | 6.7933 Errors | Standard Error 9.8653 |
| Fesoterodine 8 mg | Change From Baseline in CogState CPAL on Day 6 | -16.7905 Errors | Standard Error 9.8715 |
| Aplrazolam 1 mg | Change From Baseline in CogState CPAL on Day 6 | 58.2002 Errors | Standard Error 10.0337 |
| Placebo | Change From Baseline in CogState CPAL on Day 6 | 3.1304 Errors | Standard Error 9.9948 |
Comparison: ANCOVA was used to determine p-value for comparison of fesoterodine 4 mg vs placebo, with model terms: period and treatment as the fixed effect, participants as the random effect, and between and within participant baselines as the covariates.p-value: 0.770795% CI: [-21.4729, 28.7987]ANCOVA
Comparison: ANCOVA was used to determine p-value for comparison of fesoterodine 8 mg vs placebo, with model terms: period and treatment as the fixed effect, participants as the random effect, and between and within participant baselines as the covariates.p-value: 0.116295% CI: [-44.9634, 5.1215]ANCOVA
Secondary
Change From Baseline in CogState Groton Maze Learning Task on 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.
Time frame: Baseline and Day 6
Population: The PP Analysis Set included all randomized participants who completed the study, received treatment in all 4 study periods until the end of treatment visit in the fourth study period and who were not serious protocol violators. 'N' (Number of participants analyzed) signifies participants evaluable for the outcome measure.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Fesoterodine 4 mg | Change From Baseline in CogState Groton Maze Learning Task on Day 6 | -4.1399 Errors | Standard Error 4.2079 |
| Fesoterodine 8 mg | Change From Baseline in CogState Groton Maze Learning Task on Day 6 | -5.7717 Errors | Standard Error 4.2515 |
| Aplrazolam 1 mg | Change From Baseline in CogState Groton Maze Learning Task on Day 6 | 24.7115 Errors | Standard Error 4.2033 |
| Placebo | Change From Baseline in CogState Groton Maze Learning Task on Day 6 | -4.1467 Errors | Standard Error 4.2413 |
Comparison: ANCOVA was used to determine p-value for comparison of fesoterodine 4 mg vs placebo, with model terms: period and treatment as the fixed effect, participants as the random effect, and between and within participant baselines as the covariates.p-value: 0.998995% CI: [-9.8297, 9.8433]ANCOVA
Comparison: ANCOVA was used to determine p-value for comparison of fesoterodine 4 mg vs placebo, with model terms: period and treatment as the fixed effect, participants as the random effect, and between and within participant baselines as the covariates.p-value: 0.748595% CI: [-11.7926, 8.5425]ANCOVA
Secondary
Change From Baseline in CogState Identification Speed on 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.
Time frame: Baseline and Day 6
Population: The PP Analysis Set included all randomized participants who completed the study, received treatment in all 4 study periods until the end of treatment visit in the fourth study period and who were not serious protocol violators. 'N' (Number of participants analyzed) signifies participants evaluable for the outcome measure.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Fesoterodine 4 mg | Change From Baseline in CogState Identification Speed on Day 6 | 0.0105 Log10 MS | Standard Error 0.0084 |
| Fesoterodine 8 mg | Change From Baseline in CogState Identification Speed on Day 6 | 0.0057 Log10 MS | Standard Error 0.0085 |
| Aplrazolam 1 mg | Change From Baseline in CogState Identification Speed on Day 6 | 0.0817 Log10 MS | Standard Error 0.0084 |
| Placebo | Change From Baseline in CogState Identification Speed on Day 6 | 0.0142 Log10 MS | Standard Error 0.0085 |
Comparison: ANCOVA was used to determine p-value for comparison of fesoterodine 4 mg vs placebo, with model terms: period and treatment as the fixed effect, participants as the random effect, and between and within participant baselines as the covariates.p-value: 0.750295% CI: [-0.0268, 0.0194]ANCOVA
Comparison: ANCOVA was used to determine p-value for comparison of fesoterodine 8 mg vs placebo, with model terms: period and treatment as the fixed effect, participants as the random effect, and between and within participant baselines as the covariates.p-value: 0.478595% CI: [-0.0325, 0.0154]ANCOVA
Secondary
Change From Baseline in CogState One Card Learning on 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.
Time frame: Baseline and Day 6
Population: The PP Analysis Set included all randomized participants who completed the study, received treatment in all 4 study periods until the end of treatment visit in the fourth study period and who were not serious protocol violators. 'N' (Number of participants analyzed) signifies participants evaluable for the outcome measure.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Fesoterodine 4 mg | Change From Baseline in CogState One Card Learning on Day 6 | -0.0094 Arcsine [(sqrt) proportion correct] | Standard Error 0.0204 |
| Fesoterodine 8 mg | Change From Baseline in CogState One Card Learning on Day 6 | 0.0151 Arcsine [(sqrt) proportion correct] | Standard Error 0.0203 |
| Aplrazolam 1 mg | Change From Baseline in CogState One Card Learning on Day 6 | -0.0880 Arcsine [(sqrt) proportion correct] | Standard Error 0.0204 |
| Placebo | Change From Baseline in CogState One Card Learning on Day 6 | -0.0058 Arcsine [(sqrt) proportion correct] | Standard Error 0.0205 |
Comparison: ANCOVA was used to determine p-value for comparison of fesoterodine 4 mg vs placebo, with model terms: period and treatment as the fixed effect, participants as the random effect, and between and within participant baselines as the covariates.p-value: 0.894495% CI: [-0.0569, 0.0498]ANCOVA
Comparison: ANCOVA was used to determine p-value for comparison of fesoterodine 8 mg vs placebo, with model terms: period and treatment as the fixed effect, participants as the random effect, and between and within participant baselines as the covariates.p-value: 0.430895% CI: [-0.032, 0.0738]ANCOVA
Secondary
CogState Continuous Paired Associate Learning (CPAL)
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.
Time frame: Baseline
Population: The PP Analysis Set included all randomized participants who completed the study, received treatment in all 4 study periods until the end of treatment visit in the fourth study period and who were not serious protocol violators. 'N' (Number of participants analyzed) signifies participants evaluable for the outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Fesoterodine 4 mg | CogState Continuous Paired Associate Learning (CPAL) | 96.33 Errors | Standard Deviation 57.058 |
| Fesoterodine 8 mg | CogState Continuous Paired Associate Learning (CPAL) | 99.83 Errors | Standard Deviation 55.343 |
| Aplrazolam 1 mg | CogState Continuous Paired Associate Learning (CPAL) | 89.50 Errors | Standard Deviation 58.24 |
| Placebo | CogState Continuous Paired Associate Learning (CPAL) | 107.44 Errors | Standard Deviation 53.388 |
Secondary
CogState Groton Maze Learning Task (GMLT)
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.
Time frame: Baseline
Population: The PP Analysis Set included all randomized participants who completed the study, received treatment in all 4 study periods until the end of treatment visit in the fourth study period and who were not serious protocol violators. 'N' (Number of participants analyzed) signifies participants evaluable for the outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Fesoterodine 4 mg | CogState Groton Maze Learning Task (GMLT) | 53.72 Errors | Standard Deviation 17.091 |
| Fesoterodine 8 mg | CogState Groton Maze Learning Task (GMLT) | 58.39 Errors | Standard Deviation 15.17 |
| Aplrazolam 1 mg | CogState Groton Maze Learning Task (GMLT) | 56.83 Errors | Standard Deviation 15.023 |
| Placebo | CogState Groton Maze Learning Task (GMLT) | 52.28 Errors | Standard Deviation 15.736 |
Secondary
CogState Identification Speed
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.
Time frame: Baseline
Population: The PP Analysis Set included all randomized participants who completed the study, received treatment in all 4 study periods until the end of treatment visit in the fourth study period and who were not serious protocol violators. 'N' (Number of participants analyzed) signifies participants evaluable for the outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Fesoterodine 4 mg | CogState Identification Speed | 2.7540 Log10 MS | Standard Deviation 0.0505 |
| Fesoterodine 8 mg | CogState Identification Speed | 2.7672 Log10 MS | Standard Deviation 0.061 |
| Aplrazolam 1 mg | CogState Identification Speed | 2.7577 Log10 MS | Standard Deviation 0.0577 |
| Placebo | CogState Identification Speed | 2.7457 Log10 MS | Standard Deviation 0.0637 |
Secondary
CogState One Card Learning
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.
Time frame: Baseline
Population: The PP Analysis Set included all randomized participants who completed the study, received treatment in all 4 study periods until the end of treatment visit in the fourth study period and who were not serious protocol violators. 'N' (Number of participants analyzed) signifies participants evaluable for the outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Fesoterodine 4 mg | CogState One Card Learning | 0.9585 Arcsine [(sqrt) proportion correct] | Standard Deviation 0.0893 |
| Fesoterodine 8 mg | CogState One Card Learning | 0.9421 Arcsine [(sqrt) proportion correct] | Standard Deviation 0.0878 |
| Aplrazolam 1 mg | CogState One Card Learning | 0.9531 Arcsine [(sqrt) proportion correct] | Standard Deviation 0.1062 |
| Placebo | CogState One Card Learning | 0.9302 Arcsine [(sqrt) proportion correct] | Standard Deviation 0.0822 |
Secondary
Rey Auditory Verbal Learning Test (RAVLT)
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.
Time frame: Baseline
Population: The PP Analysis Set included all randomized participants who completed the study, received treatment in all 4 study periods until the end of treatment visit in the fourth study period and who were not serious protocol violators. 'N' (Number of participants analyzed) signifies participants evaluable for the outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Fesoterodine 4 mg | Rey Auditory Verbal Learning Test (RAVLT) | 6.50 Words Recalled | Standard Deviation 3.884 |
| Fesoterodine 8 mg | Rey Auditory Verbal Learning Test (RAVLT) | 6.67 Words Recalled | Standard Deviation 3.63 |
| Aplrazolam 1 mg | Rey Auditory Verbal Learning Test (RAVLT) | 7.22 Words Recalled | Standard Deviation 3.687 |
| Placebo | Rey Auditory Verbal Learning Test (RAVLT) | 6.33 Words Recalled | Standard Deviation 3.378 |
Secondary
Rey Auditory Verbal Learning Test (RAVLT) on 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.
Time frame: Baseline and Day 6
Population: The PP Analysis Set included all randomized participants who completed the study, received treatment in all 4 study periods until the end of treatment visit in the fourth study period and who were not serious protocol violators. 'N' (Number of participants analyzed) signifies participants evaluable for the outcome measure.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Fesoterodine 4 mg | Rey Auditory Verbal Learning Test (RAVLT) on Day 6 | 0.1565 Words Recalled | Standard Error 0.5825 |
| Fesoterodine 8 mg | Rey Auditory Verbal Learning Test (RAVLT) on Day 6 | -0.1780 Words Recalled | Standard Error 0.582 |
| Aplrazolam 1 mg | Rey Auditory Verbal Learning Test (RAVLT) on Day 6 | -3.9222 Words Recalled | Standard Error 0.589 |
| Placebo | Rey Auditory Verbal Learning Test (RAVLT) on Day 6 | -0.1119 Words Recalled | Standard Error 0.5862 |
Comparison: ANCOVA was used to determine p-value for comparison of fesoterodine 4 mg vs placebo, with model terms: period and treatment as the fixed effect, participants as the random effect, and between and within participant baselines as the covariates.p-value: 0.745895% CI: [-1.3788, 1.9157]ANCOVA
Comparison: ANCOVA was used to determine p-value for comparison of fesoterodine 8 mg vs placebo, with model terms: period and treatment as the fixed effect, participants as the random effect, and between and within participant baselines as the covariates.p-value: 0.936695% CI: [-1.7202, 1.588]ANCOVA