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

Study Overview

• Status: Completed
• Conditions: Cognition; Memory
• Intervention / Treatment: Drug: Tolterodine ER; Drug: Oxybutynin ER

• Study Type: Interventional
• Enrollment: 220
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Tucson, Arizona, United States, 85741
      • Pfizer Investigational Site
  • Florida
    • 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
    • Saint Petersburg, Florida, United States, 33709
      • Pfizer Investigational Site
    • Tampa, Florida, United States, 33606
      • Pfizer Investigational Site
    • West Palm Beach, Florida, United States, 33407
      • Pfizer Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years to 75 years (Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
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

Outcome Measure
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)

Collaborators and Investigators

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

Publications and helpful links

Helpful Links

• To obtain contact information for a study center near you, click here.

Study record dates

Study Major Dates

• Study Start: December 1, 2006
• Primary Completion (Actual): June 1, 2007
• Study Completion (Actual): June 1, 2007

Study Registration Dates

• First Submitted: December 13, 2006
• First Submitted That Met QC Criteria: December 13, 2006
• First Posted (Estimate): December 14, 2006

Study Record Updates

• Last Update Posted (Actual): January 27, 2021
• Last Update Submitted That Met QC Criteria: January 26, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Parasympatholytics; Autonomic Agents; Peripheral Nervous System Agents; Muscarinic Antagonists; Cholinergic Antagonists; Cholinergic Agents; Urological Agents; Oxybutynin; Tolterodine Tartrate
• Other Study ID Numbers: A6121154