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

History of Changes

Results First Received: May 25, 2012

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Pharmacodynamics Study; Intervention Model: Crossover Assignment; Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Condition:	Healthy
Interventions:	Drug: 4mg fesoterodine Drug: 8mg fesoterodine Drug: alprazolam 1mg Drug: Placebo

Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups

	Description
Fesoterodine 4 mg, Placebo, Fesoterodine 8 mg, Aplrazolam 1 mg	Fesoterodine 4 milligram (mg) tablet administered orally once daily (OD) for 6 days along with placebo matched to a single oral dose of alprazolam 1 mg capsule on Day 6 in the first intervention period; followed by placebo matched to fesoterodine 4 mg or 8 mg tablet orally OD for 6 days along with placebo matched to a single oral dose of alprazolam 1 mg capsule on Day 6 in the second intervention period; then fesoterodine 4 mg tablet administered orally OD for the first 3 days followed by fesoterodine 8 mg tablet orally OD for the next 3 days along with placebo matched to a single oral dose of alprazolam 1 mg capsule on Day 6 in the third intervention period; and placebo matched to fesoterodine 4 mg or 8 mg tablet administered orally OD for 6 days along with a single oral dose of alprazolam 1 mg capsule on Day 6 in the fourth intervention period. A washout period of at least 3 to 6 days was maintained between each treatment period.
Fesoterodine 8 mg, Fesoterodine 4 mg, Aplrazolam 1 mg, Placebo	Fesoterodine 4 mg tablet administered orally OD for the first 3 days followed by fesoterodine 8 mg tablet orally OD for the next 3 days along with placebo matched to a single oral dose of alprazolam 1 mg capsule on Day 6 in the first intervention period; then fesoterodine 4 mg tablet administered orally OD for 6 days along with placebo matched to a single oral dose of alprazolam 1 mg capsule on Day 6 in the second intervention period; followed by placebo matched to fesoterodine 4 mg or 8 mg tablet administered orally OD for 6 days along with a single oral dose of alprazolam 1 mg capsule on Day 6 in the third intervention period; and placebo matched to fesoterodine 4 mg or 8 mg tablet orally OD for 6 days along with placebo matched to a single oral dose of alprazolam 1 mg capsule on Day 6 in the fourth intervention period. A washout period of at least 3 to 6 days was maintained between each treatment period.
Aplrazolam 1 mg, Fesoterodine 8 mg, Placebo, Fesoterodine 4 mg	Placebo matched to fesoterodine 4 mg or 8 mg tablet administered orally OD for 6 days along with a single oral dose of alprazolam 1 mg capsule on Day 6 in the first intervention period; followed by fesoterodine 4 mg tablet administered orally OD for the first 3 days followed by fesoterodine 8 mg tablet orally OD for the next 3 days along with placebo matched to a single oral dose of alprazolam 1 mg capsule on Day 6 in the second intervention period; then placebo matched to fesoterodine 4 mg or 8 mg tablet orally OD for 6 days along with placebo matched to a single oral dose of alprazolam 1 mg capsule on Day 6 in the third intervention period; and fesoterodine 4 mg tablet administered orally OD for 6 days along with placebo matched to a single oral dose of alprazolam 1 mg capsule on Day 6 in the fourth intervention period. A washout period of at least 3 to 6 days was maintained between each treatment period.
Placebo, Aplrazolam 1 mg, Fesoterodine 4 mg, Fesoterodine 8 mg	Placebo matched to fesoterodine 4 mg or 8 mg tablet orally OD for 6 days along with placebo matched to a single oral dose of alprazolam 1 mg capsule on Day 6 in the first intervention period; followed by placebo matched to fesoterodine 4 mg or 8 mg tablet administered orally OD for 6 days along with a single oral dose of alprazolam 1 mg capsule on Day 6 in the second intervention period; then fesoterodine 4 mg tablet administered orally OD for 6 days along with placebo matched to a single oral dose of alprazolam 1 mg capsule on Day 6 in the third intervention period; and fesoterodine 4 mg tablet administered orally OD for the first 3 days followed by fesoterodine 8 mg tablet orally OD for the next 3 days along with placebo matched to a single oral dose of alprazolam 1 mg capsule on Day 6 in the fourth intervention period. A washout period of at least 3 to 6 days was maintained between each treatment period.

Participant Flow for 7 periods

Period 1: First Intervention Period

	Fesoterodine 4 mg, Placebo, Fesoterodine 8 mg, Aplrazolam 1 mg	Fesoterodine 8 mg, Fesoterodine 4 mg, Aplrazolam 1 mg, Placebo	Aplrazolam 1 mg, Fesoterodine 8 mg, Placebo, Fesoterodine 4 mg	Placebo, Aplrazolam 1 mg, Fesoterodine 4 mg, Fesoterodine 8 mg
STARTED	5	5	5	5
Treated	5	5	5	5
COMPLETED	5	5	5	5
NOT COMPLETED	0	0	0	0

Period 2: Washout Period (At Least 3 to 6 Days)

	Fesoterodine 4 mg, Placebo, Fesoterodine 8 mg, Aplrazolam 1 mg	Fesoterodine 8 mg, Fesoterodine 4 mg, Aplrazolam 1 mg, Placebo	Aplrazolam 1 mg, Fesoterodine 8 mg, Placebo, Fesoterodine 4 mg	Placebo, Aplrazolam 1 mg, Fesoterodine 4 mg, Fesoterodine 8 mg
STARTED	5	5	5	5
COMPLETED	5	5	5	5
NOT COMPLETED	0	0	0	0

Period 3: Second Intervention Period

	Fesoterodine 4 mg, Placebo, Fesoterodine 8 mg, Aplrazolam 1 mg	Fesoterodine 8 mg, Fesoterodine 4 mg, Aplrazolam 1 mg, Placebo	Aplrazolam 1 mg, Fesoterodine 8 mg, Placebo, Fesoterodine 4 mg	Placebo, Aplrazolam 1 mg, Fesoterodine 4 mg, Fesoterodine 8 mg
STARTED	5	5	5	5
COMPLETED	5	5	5	5
NOT COMPLETED	0	0	0	0

Period 4: Washout Period (At Least 3 to 6 Days)

	Fesoterodine 4 mg, Placebo, Fesoterodine 8 mg, Aplrazolam 1 mg	Fesoterodine 8 mg, Fesoterodine 4 mg, Aplrazolam 1 mg, Placebo	Aplrazolam 1 mg, Fesoterodine 8 mg, Placebo, Fesoterodine 4 mg	Placebo, Aplrazolam 1 mg, Fesoterodine 4 mg, Fesoterodine 8 mg
STARTED	5	5	5	5
COMPLETED	4	5	5	5
NOT COMPLETED	1	0	0	0
Withdrawal by Subject	1	0	0	0

Period 5: Third Intervention Period

	Fesoterodine 4 mg, Placebo, Fesoterodine 8 mg, Aplrazolam 1 mg	Fesoterodine 8 mg, Fesoterodine 4 mg, Aplrazolam 1 mg, Placebo	Aplrazolam 1 mg, Fesoterodine 8 mg, Placebo, Fesoterodine 4 mg	Placebo, Aplrazolam 1 mg, Fesoterodine 4 mg, Fesoterodine 8 mg
STARTED	4	5	5	5
COMPLETED	4	5	5	5
NOT COMPLETED	0	0	0	0

Period 6: Washout Period (At Least 3 to 6 Days)

	Fesoterodine 4 mg, Placebo, Fesoterodine 8 mg, Aplrazolam 1 mg	Fesoterodine 8 mg, Fesoterodine 4 mg, Aplrazolam 1 mg, Placebo	Aplrazolam 1 mg, Fesoterodine 8 mg, Placebo, Fesoterodine 4 mg	Placebo, Aplrazolam 1 mg, Fesoterodine 4 mg, Fesoterodine 8 mg
STARTED	4	5	5	5
COMPLETED	4	5	5	5
NOT COMPLETED	0	0	0	0

Period 7: Fourth Intervention Period

	Fesoterodine 4 mg, Placebo, Fesoterodine 8 mg, Aplrazolam 1 mg	Fesoterodine 8 mg, Fesoterodine 4 mg, Aplrazolam 1 mg, Placebo	Aplrazolam 1 mg, Fesoterodine 8 mg, Placebo, Fesoterodine 4 mg	Placebo, Aplrazolam 1 mg, Fesoterodine 4 mg, Fesoterodine 8 mg
STARTED	4	5	5	5
COMPLETED	4	5	5	5
NOT COMPLETED	0	0	0	0

Baseline Characteristics

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Outcome Measures

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1. Primary:

Computer Based Objective Cognition Testing (CogState) Detection Speed [ Time Frame: Baseline ]

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2. Primary:

Change From Baseline in Computer Based Objective Cognition Testing (CogState) Detection Speed on Day 6 [ Time Frame: Baseline and Day 6 ]

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3. Secondary:

CogState Identification Speed [ Time Frame: Baseline ]

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4. Secondary:

Change From Baseline in CogState Identification Speed on Day 6 [ Time Frame: Baseline and Day 6 ]

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5. Secondary:

CogState One Card Learning [ Time Frame: Baseline ]

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6. Secondary:

Change From Baseline in CogState One Card Learning on Day 6 [ Time Frame: Baseline and Day 6 ]

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7. Secondary:

CogState Continuous Paired Associate Learning (CPAL) [ Time Frame: Baseline ]

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8. Secondary:

Change From Baseline in CogState CPAL on Day 6 [ Time Frame: Baseline and Day 6 ]

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9. Secondary:

CogState Groton Maze Learning Task (GMLT) [ Time Frame: Baseline ]

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10. Secondary:

Change From Baseline in CogState Groton Maze Learning Task on Day 6 [ Time Frame: Baseline and Day 6 ]

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11. Secondary:

Rey Auditory Verbal Learning Test (RAVLT) [ Time Frame: Baseline ]

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12. Secondary:

Rey Auditory Verbal Learning Test (RAVLT) on Day 6 [ Time Frame: Baseline and Day 6 ]

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Serious Adverse Events

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Other Adverse Events

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More Information

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Certain Agreements:

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

The agreement is:

	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. Restriction Description: Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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Results Point of Contact:

Name/Title: Pfizer ClinicalTrials.gov Call Center
Organization: Pfizer, Inc.
phone: 1-800-718-1021
e-mail: ClinicalTrials.gov_Inquiries@pfizer.com

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

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