Effects Of Detrol LA On Memory And Cognition In Elderly Population

Study Description

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Brief Summary:

The primary purpose of the trial is to show that tolterodine ER has no effect on memory and other cognitive abilities in an elderly population

Condition or disease	Intervention/treatment	Phase
Memory; Cognition	Drug: Tolterodine ER; Drug: Oxybutynin ER	Phase 4

Study Design

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Study Type :	Interventional (Clinical Trial)
Enrollment :	220 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Double
Primary Purpose:	Treatment
Official Title:	A Randomized, Double-Blind, Placebo-Controlled, Three Arm Study To Evaluate The Effects Of Tolterodine ER 4 mg Vs. Placebo Vs. Oxybutynin ER On Memory And Other Cognitive Abilities In Elderly Subjects
Study Start Date :	December 2006
Actual Primary Completion Date :	June 2007
Actual Study Completion Date :	June 2007

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Outcome Measures

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :

1. Delayed Recall on the Name-Face Association Test at Week 3 (tolterodine ER vs. placebo) - Number of correct responses to the test

Secondary Outcome Measures :

1. 1. Cognitive effects of tolterodine ER vs. placebo at Weeks 1 and 2 on Delayed Recall on the Name-Face Association Test - Number of correct responses to the
2. test 2. Cognitive effects of tolterodine ER vs. oxybutynin ER and oxybutynin ER vs. placebo at Weeks 1, 2, and 3 on Delayed Recall on the Name-Face
3. Association Test - Number of correct responses to the test 3. Other cognitive effects in the following three paired comparisons: tolterodine ER vs. placebo;
4. tolterodine ER vs. oxybutynin ER; and oxybutynin ER vs. placebo on: 3a) Delayed Recall Domain (Verbal and Visual) at Weeks 1, 2, and 3: 3a_i) Delayed Recall on
5. the First-Last Name Association Test - Number of correct responses to the test 3a_ii) Misplaced Objects Test - Number of correct recalls at the first attempt 3b)
6. Immediate Recall Domain at Weeks 1, 2, and 3: 3b_i) Immediate Recall on the Name-Face Association Test - Number of correct responses to the test in the first
7. acquisition - Number of correct responses to the test in the second acquisition 3b_ii) Immediate Recall on the First-Last Name Association Test - Number of
8. correct responses to the test in the first acquisition - Number of correct responses to the test in the second acquisition 3b_iii) Facial Recognition Test - Number of
9. correct responses before first miss - Total correct responses 3c) Visual Attention and Memory Domain at Weeks 1, 2, and 3: 3c_i) Matching-to-Sample Test -
10. Throughput (number of correct responses / minute) 3c_ii) Visual Sequence Comparison Test - Throughput (number of correct responses / minute) 3d)
11. Psychomotor/Reaction-Time Domain at Weeks 1, 2, and 3: 3d_i) Divided Attention Test (response speed to visual monitoring task alone) - Median response time for
12. correct responses (seconds)

Eligibility Criteria

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Ages Eligible for Study:	65 Years to 75 Years (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

• Male or female subjects with age of 65 - 75 years
• Having a score of greater than or equal to 26 on the Mini-Mental State Exam (MMSE)

Exclusion Criteria:

• Current or history of bladder outlet obstruction. Previous history of acute urinary retention requiring catheterization, or severe voiding difficulties in the judgment of the investigator, prior to randomization
• Significant hepatic or renal disease, defined as twice the upper limit of the reference ranges regarding serum concentrations of AST, ALT, ALP, urea nitrogen, or creatinine

Contacts and Locations

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Locations

United States, Arizona
Pfizer Investigational Site
Tucson, Arizona, United States, 85741
United States, Florida
Pfizer Investigational Site
Brooksville, Florida, United States, 34613
Pfizer Investigational Site
DeLand, Florida, United States, 32720
Pfizer Investigational Site
Naples, Florida, United States, 34102
Pfizer Investigational Site
Ocala, Florida, United States, 34471
Pfizer Investigational Site
Ocala, Florida, United States, 34474
Pfizer Investigational Site
St. Petersburg, Florida, United States, 33709
Pfizer Investigational Site
Tampa, Florida, United States, 33606
Pfizer Investigational Site
West Palm Beach, Florida, United States, 33407

Sponsors and Collaborators

Pfizer

Investigators

Study Director:	Pfizer CT.gov Call Center	Pfizer

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Additional Information:

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

ClinicalTrials.gov Identifier:	NCT00411437 History of Changes
Other Study ID Numbers:	A6121154
First Posted:	December 14, 2006
Last Update Posted:	June 11, 2008
Last Verified:	June 2008

Additional relevant MeSH terms:

Tolterodine Tartrate; Oxybutynin; Muscarinic Antagonists; Cholinergic Antagonists; Cholinergic Agents; Neurotransmitter Agents	Molecular Mechanisms of Pharmacological Action; Physiological Effects of Drugs; Urological Agents; Parasympatholytics; Autonomic Agents; Peripheral Nervous System Agents