Effects Of Detrol LA On Memory And Cognition In Elderly Population
Information source: Pfizer
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Memory; Cognition
Intervention: Tolterodine ER (Drug); Oxybutynin ER (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: Pfizer Official(s) and/or principal investigator(s): Pfizer CT.gov Call Center, Study Director, Affiliation: Pfizer
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
Clinical Details
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 design: Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
Primary outcome: Delayed Recall on the Name-Face Association Test at Week 3 (tolterodine ER vs. placebo) - Number of correct responses to the test
Secondary outcome: 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 thetest 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)
Eligibility
Minimum age: 65 Years.
Maximum age: 75 Years.
Gender(s): Both.
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
Locations and Contacts
Pfizer Investigational Site, Tucson, Arizona 85741, United States
Pfizer Investigational Site, Brooksville, Florida 34613, United States
Pfizer Investigational Site, DeLand, Florida 32720, United States
Pfizer Investigational Site, Naples, Florida 34102, United States
Pfizer Investigational Site, Ocala, Florida 34471, United States
Pfizer Investigational Site, Ocala, Florida 34474, United States
Pfizer Investigational Site, St. Petersburg, Florida 33709, United States
Pfizer Investigational Site, Tampa, Florida 33606, United States
Pfizer Investigational Site, West Palm Beach, Florida 33407, United States
Additional Information
To obtain contact information for a study center near you, click here.
Starting date: December 2006
Last updated: June 10, 2008
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