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Trial record 1 of 1 for:    NCT00411437
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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 : January 27, 2021
Sponsor:
Information provided by:
Pfizer

Tracking Information
First Submitted Date  ICMJE December 13, 2006
First Posted Date  ICMJE December 14, 2006
Last Update Posted Date January 27, 2021
Study Start Date  ICMJE December 2006
Actual Primary Completion Date June 2007   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 8, 2007)
Delayed Recall on the Name-Face Association Test at Week 3 (tolterodine ER vs. placebo) - Number of correct responses to the test
Original Primary Outcome Measures  ICMJE
 (submitted: December 13, 2006)
  • Delayed Recall on the Name-Face Association Test at Week 3 (tolterodine ER vs.
  • placebo) - Number of correct responses to the test
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 6, 2007)
  • 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)
Original Secondary Outcome Measures  ICMJE
 (submitted: December 13, 2006)
  • 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
  • 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- Thruput (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)
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effects Of Detrol LA On Memory And Cognition In Elderly Population
Official Title  ICMJE 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
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
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Condition  ICMJE
  • Memory
  • Cognition
Intervention  ICMJE
  • Drug: Tolterodine ER
  • Drug: Oxybutynin ER
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Enrollment  ICMJE
 (submitted: December 13, 2006)
220
Original Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE June 2007
Actual Primary Completion Date June 2007   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 65 Years to 75 Years   (Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00411437
Other Study ID Numbers  ICMJE A6121154
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date January 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP