Effects Of Detrol LA On Memory And Cognition In Elderly Population

NCT00411437 | Completed Phase 4

• 1 other identifier: A6121154
• Study Type: interventional
• Target: 220
• Locations: 1 country
• Sites: 9

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

Conditions

Memory; Cognition

Outcome Measures

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 (12)

• 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)

Interventions

Tolterodine ER DRUG

Oxybutynin ER DRUG

Eligibility Criteria

• Age: 65 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (9)

Pfizer Investigational Site

Tucson, Arizona, 85741, United States

Location

Pfizer Investigational Site

Brooksville, Florida, 34613, United States

Location

Pfizer Investigational Site

DeLand, Florida, 32720, United States

Location

Pfizer Investigational Site

Naples, Florida, 34102, United States

Location

Pfizer Investigational Site

Ocala, Florida, 34471, United States

Location

Pfizer Investigational Site

Ocala, Florida, 34474, United States

Location

Pfizer Investigational Site

St. Petersburg, Florida, 33709, United States

Location

Pfizer Investigational Site

Tampa, Florida, 33606, United States

Location

Pfizer Investigational Site

West Palm Beach, Florida, 33407, United States

Location

Related Links

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

MeSH Terms

Interventions

Tolterodine Tartrate

Intervention Hierarchy (Ancestors)

Phenylpropanolamine; Propanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Propanols; Amines; Benzhydryl Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Cresols; Phenols

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: December 13, 2006
• First Posted: December 14, 2006
• Study Start: December 1, 2006
• Primary Completion: June 1, 2007
• Study Completion: June 1, 2007
• Last Updated: January 27, 2021

Record last verified: 2021-01

Locations

US (9)