Effects Of Detrol LA On Memory And Cognition In Elderly Population - Full Text View

Sponsored by:	Pfizer
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT00411437

Purpose

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	Intervention	Phase
Memory Cognition	Drug: Tolterodine ER Drug: Oxybutynin ER	Phase IV

MedlinePlus related topics: Memory

Drug Information available for: Tolterodine Tolterodine tartrate Oxybutynin Oxybutynin chloride

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Pharmacodynamics Study
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

Further study details as provided by Pfizer:

Primary Outcome Measures:

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. 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
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
Association Test - Number of correct responses to the test 3. Other cognitive effects in the following three paired comparisons: tolterodine ER vs. placebo;
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
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)
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
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
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
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 -
Throughput (number of correct responses / minute) 3c_ii) Visual Sequence Comparison Test - Throughput (number of correct responses / minute) 3d)
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
correct responses (seconds)

Estimated Enrollment:	220
Study Start Date:	December 2006
Study Completion Date:	June 2007
Primary Completion Date:	June 2007 (Final data collection date for primary outcome measure)

Eligibility

Ages Eligible for Study:	65 Years to 75 Years
Genders Eligible for Study:	Both
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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00411437

Locations

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

Sponsors and Collaborators

Pfizer

Investigators

Study Director:

Pfizer CT.gov Call Center

Pfizer

More Information

To obtain contact information for a study center near you, click here. This link exits the ClinicalTrials.gov site

Link to ClinicalStudyResults.org posting This link exits the ClinicalTrials.gov site

Study ID Numbers:	A6121154
Study First Received:	December 13, 2006
Last Updated:	June 10, 2008
ClinicalTrials.gov Identifier:	NCT00411437
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Oxybutynin
Tolterodine

Additional relevant MeSH terms:

Muscarinic Antagonists
Parasympatholytics
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Cholinergic Antagonists

Autonomic Agents
Physiological Effects of Drugs
Peripheral Nervous System Agents
Cholinergic Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009