HealthyPhase 1NCT01161472
A Study to Assess the Cognitive Effects of Fesoterodine in Elderly Subjects
A Phase 1 study testing 4mg fesoterodine, 8mg fesoterodine and alprazolam 1mg in people with Healthy, run by Pfizer at 2 sites in United States.
Trial summary
The study is designed to evaluate elements of cognitive function in subjects receiving either fesoterodine or alprazolam. Read more about this study
- Who is it for?
- Ages 65 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- 4mg fesoterodine, 8mg fesoterodine and alprazolam 1mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 2 sitesUnited States
- Study dates
- Jul 2010to Sep 2010
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 to 85 years
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Adult healthy volunteers 65 years and over with minimum MMSE of 26
Who cannot join
- Prohibited concomitant medications
- Confounding medical conditions
- Clinically significant comorbid diseases
- Hypersensitivity or contraindications to fesoterodine or active control
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Pfizer Investigational Site
Overland Park, Kansas, 66211
Pfizer Investigational Site
Overland Park, Kansas, 66212
About this study
Official title: A 4 Way Placebo And Active Controlled Study To Evaluate The Effects Of Fesoterodine On Cognitive Function In Healthy Elderly Subjects
The study is designed to evaluate elements of cognitive function in subjects receiving either fesoterodine or alprazolam.
Read the detailed description
Evaluation of cognitive function
- Conditions
- Healthy
- Being tested
- 4mg fesoterodine, 8mg fesoterodine, alprazolam 1mg, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
4mg fesoterodineDrug
4mg tablet once daily for 6 days
8mg fesoterodineDrug
4mg tablet once daily for 3 days followed by 8mg tablet once daily for 3 days
alprazolam 1mgDrug
1mg tablet once on last day of treatment period at clinic
PlaceboDrug
Placebo tablet for fesoterodine once daily for 6 days and placebo tablet for alprazolam once on last day of treatment period at clinic
| Study group | Role | What they receive |
|---|---|---|
| 4mg fesoterodine | Experimental | Not described Receives: Drug: 4mg fesoterodine |
| fesoterodine 8mg | Experimental | Not described Receives: Drug: 8mg fesoterodine |
| 1mg alprazolam | Active comparator | Not described Receives: Drug: alprazolam 1mg |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline
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.
Measured: Baseline and Day 6
Secondary outcomes (10)
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.
Measured: Baseline
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.
Measured: Baseline and Day 6
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.
Measured: Baseline
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.
Measured: Baseline and Day 6
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.
Measured: Baseline
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.
Measured: Baseline and Day 6
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.
Measured: Baseline
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.
Measured: Baseline and Day 6
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.
Measured: Baseline
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.
Measured: Baseline and Day 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2010 (estimated)
- Study startJul 2010
- Primary completionSep 2010
- Study completionSep 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by PfizerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01161472
- Sponsor's protocol ID
- A0221086
- Status last verified
- May 2012
- First submitted
- 12 Jul 2010
- Last updated
- 28 Jun 2012
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 4 Way Placebo And Active Controlled Study To Evaluate The Effects Of Fesoterodine On Cognitive Function In Healthy Elderly Subjects
- ClinicalTrials.gov ID
- NCT01161472
- Acronym / sponsor ID
- A0221086
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- Jul 2010
- Primary completion
- Sep 2010 (actual)
- Study completion
- Sep 2010 (actual)
- First posted
- 13 Jul 2010 (estimated)
- Results
- Posted 28 Jun 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study is designed to evaluate elements of cognitive function in subjects receiving either fesoterodine or alprazolam.
Detailed description
Evaluation of cognitive function
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 4mg fesoterodine | Experimental | Drug: 4mg fesoterodine |
| fesoterodine 8mg | Experimental | Drug: 8mg fesoterodine |
| 1mg alprazolam | Active comparator | Drug: alprazolam 1mg |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 65 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (1 listed)
- Adult healthy volunteers 65 years and over with minimum MMSE of 26
Key exclusion criteria (4 listed)
- Prohibited concomitant medications
- Confounding medical conditions
- Clinically significant comorbid diseases
- Hypersensitivity or contraindications to fesoterodine or active control
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 4mg fesoterodine4mg tablet once daily for 6 days | Drug | 4mg fesoterodine |
| 8mg fesoterodine4mg tablet once daily for 3 days followed by 8mg tablet once daily for 3 days | Drug | fesoterodine 8mg |
| alprazolam 1mg1mg tablet once on last day of treatment period at clinic | Drug | 1mg alprazolam |
| PlaceboPlacebo tablet for fesoterodine once daily for 6 days and placebo tablet for alprazolam once on last day of treatment period at clinic | Drug | Placebo |
Primary outcome
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.
10 secondary outcomes
CogState Identification Speed
Time frame: Baseline
Change From Baseline in CogState Identification Speed on Day 6
Time frame: Baseline and Day 6
CogState One Card Learning
Time frame: Baseline
Change From Baseline in CogState One Card Learning on Day 6
Time frame: Baseline and Day 6
CogState Continuous Paired Associate Learning (CPAL)
Time frame: Baseline
Change From Baseline in CogState CPAL on Day 6
Time frame: Baseline and Day 6
CogState Groton Maze Learning Task (GMLT)
Time frame: Baseline
Change From Baseline in CogState Groton Maze Learning Task on Day 6
Time frame: Baseline and Day 6
Rey Auditory Verbal Learning Test (RAVLT)
Time frame: Baseline
Rey Auditory Verbal Learning Test (RAVLT) on Day 6
Time frame: Baseline and Day 6
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jun 2012.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pfizer CT.gov Call Center study director
Pfizer
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing 4mg fesoterodine, 8mg fesoterodine and alprazolam 1mg in people with Healthy, run by Pfizer at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Jun 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 28 Jun 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Computer Based Objective Cognition Testing (CogState) Detection Speed (time frame: Baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jun 2012.