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Completed

NCT Number: NCT00411437

Effects Of Detrol LA On Memory And Cognition In Elderly Population

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

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Key information

Conditions

Memory Cognition

Age range

65 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Pfizer Investigational Site, Tucson, Arizona, United States

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Tolterodine ER

Drug

Oxybutynin ER

Drug

Primary outcomes

  1. Delayed Recall on the Name-Face Association Test at Week 3 (tolterodine ER vs. placebo) - Number of correct responses to the test

Secondary outcomes

  1. 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

  2. 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

  3. Association Test - Number of correct responses to the test 3. Other cognitive effects in the following three paired comparisons: tolterodine ER vs. placebo;

  4. 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

  5. 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)

  6. 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

  7. 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

  8. 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

  9. 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 -

  10. Throughput (number of correct responses / minute) 3c_ii) Visual Sequence Comparison Test - Throughput (number of correct responses / minute) 3d)

  11. 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

  12. correct responses (seconds)

Sponsors and collaborators

Lead sponsor

Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

Industry

Registry information

Official study 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

Important dates

Study start
2006
Primary completion
2007
Study completion
2007
First posted
Dec 14, 2006
Registry last updated
Jan 27, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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