Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Effects Of Detrol LA On Memory And Cognition In Elderly Population

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00411437
First received: December 13, 2006
Last updated: June 10, 2008
Last verified: June 2008

December 13, 2006
June 10, 2008
December 2006
June 2007   (final data collection date for primary outcome measure)
Delayed Recall on the Name-Face Association Test at Week 3 (tolterodine ER vs. placebo) - Number of correct responses to the test
  • Delayed Recall on the Name-Face Association Test at Week 3 (tolterodine ER vs.
  • placebo) - Number of correct responses to the test
Complete list of historical versions of study NCT00411437 on ClinicalTrials.gov Archive Site
  • 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)
  • 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)
Not Provided
Not Provided
 
Effects Of Detrol LA On Memory And Cognition In Elderly Population
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

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

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
  • Memory
  • Cognition
  • Drug: Tolterodine ER
  • Drug: Oxybutynin ER
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
220
June 2007
June 2007   (final data collection date for primary outcome measure)

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
Both
65 Years to 75 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00411437
A6121154
Not Provided
Not Provided
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
June 2008

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