Effects Of Detrol LA On Memory And Cognition In Elderly Population

• ClinicalTrials.gov Identifier: NCT00411437
• Recruitment Status: Completed
• First Posted: December 14, 2006
• Last Update Posted: June 11, 2008
• Sponsor: Pfizer
• Information provided by: Pfizer

Study Description

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

Condition or disease	Intervention/treatment	Phase
Memory; Cognition	Drug: Tolterodine ER; Drug: Oxybutynin ER	Phase 4

Study Design

• Study Type: Interventional (Clinical Trial)
• Enrollment: 220 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double
• Primary Purpose: Treatment
• Official 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
• Study Start Date: December 2006
• Actual Primary Completion Date: June 2007
• Actual Study Completion Date: June 2007

Arms and Interventions

Outcome Measures

Primary Outcome Measures :

1. 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 :

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)

Eligibility Criteria

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

Criteria

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

Contacts and Locations

Locations

United States, Arizona

Pfizer Investigational Site

Tucson, Arizona, United States, 85741

United States, Florida

Pfizer Investigational Site

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

St. Petersburg, Florida, United States, 33709

Pfizer Investigational Site

Tampa, Florida, United States, 33606

Pfizer Investigational Site

West Palm Beach, Florida, United States, 33407

Sponsors and Collaborators

Pfizer

Investigators

• Study Director: Pfizer CT.gov Call Center; Pfizer

More Information

Additional Information:

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

• ClinicalTrials.gov Identifier: NCT00411437
• Other Study ID Numbers: A6121154
• First Posted: December 14, 2006
• Last Update Posted: June 11, 2008
• Last Verified: June 2008

Additional relevant MeSH terms:

Tolterodine Tartrate; Oxybutynin; Muscarinic Antagonists; Cholinergic Antagonists; Cholinergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Physiological Effects of Drugs; Urological Agents; Parasympatholytics; Autonomic Agents; Peripheral Nervous System Agents