Effects Of Detrol LA On Memory And Cognition In Elderly Population
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ClinicalTrials.gov Identifier: NCT00411437 |
Recruitment Status :
Completed
First Posted : December 14, 2006
Last Update Posted : June 11, 2008
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Memory Cognition | Drug: Tolterodine ER Drug: Oxybutynin ER | Phase 4 |
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 |
- Delayed Recall on the Name-Face Association Test at Week 3 (tolterodine ER vs. placebo) - Number of correct responses to the test
- 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)

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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00411437
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 |
Study Director: | Pfizer CT.gov Call Center | Pfizer |
ClinicalTrials.gov Identifier: | NCT00411437 |
Other Study ID Numbers: |
A6121154 |
First Posted: | December 14, 2006 Key Record Dates |
Last Update Posted: | June 11, 2008 |
Last Verified: | June 2008 |
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 |