Effects Of Detrol LA On Memory And Cognition In Elderly Population
This study has been completed.
Sponsor:
Pfizer
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00411437
First received: December 13, 2006
Last updated: June 10, 2008
Last verified: June 2008
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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 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Pharmacodynamics Study Intervention Model: Parallel Assignment Masking: Double-Blind 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 |
Resource links provided by NLM:
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 (Adult, Senior) |
| 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
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To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00411437
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 | |
| 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
Additional Information:
| ClinicalTrials.gov Identifier: | NCT00411437 History of Changes |
| Other Study ID Numbers: | A6121154 |
| Study First Received: | December 13, 2006 |
| Last Updated: | June 10, 2008 |
| Health Authority: | United States: Food and Drug Administration |
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 |
ClinicalTrials.gov processed this record on September 30, 2016