Sanctura Muscarinic Receptor Antagonist Resists Transport (SMART-II) Trial

Study Overview
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Brief Summary
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This study will evaluate the cerebrospinal fluid levels of trospium chloride (Sanctura XR®) and oxybutynin immediate release (Oxybutynin IR) on memory performance in patients with overactive bladder and age associated memory impairment.

Conditions
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Overactive Bladder

Intervention / Treatment
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* Drug: trospium chloride
* Drug: oxybutynin IR
* Drug: oxybutynin IR placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient presents symptoms of overactive bladder Patient has age associated memory impairment No acute or unstable medical conditions Exclusion Criteria: History of alcohol or substance abuse within 1 year prior to study Has donated in excess of 500mL of blood or plasma in the 30 days prior to study Has known bleeding disorder (hemophilia) Previous abdominal bypass surgery for obesity

Ages Eligible for Study
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Minimum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Sanctura XR®<br>Sanctura XR® (trospium chloride), 60mg once daily for 10 days | Drug: trospium chloride<br>* trospium chloride (60mg) once daily for 10 days<br>* Other names: Sanctura XR®;|
| Active Comparator: Oxybutynin IR<br>Oxybutynin IR (oxybutynin immediate release), 5 mg three times daily for 2 days | Drug: oxybutynin IR<br>* oxybutynin IR (5 mg) three times daily for 2 days<br>|
| Placebo Comparator: Oxybutynin IR placebo<br>Oxybutynin IR placebo three times daily for 2 days | Drug: oxybutynin IR placebo<br>* oxybutynin IR placebo three times daily for 2 days<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cerebral Spinal Fluid Levels of Sanctura XR® at Day 10 Post-dose | Cerebral spinal fluid levels of Sanctura XR® at Day 10 Post-dose. Cerebral spinal fluid is the fluid that surrounds the spinal cord and the inside of the brain. Samples were drawn from patients who received Sanctura XR®. | Day 10 Post-Dose | 
| Cerebral Spinal Fluid Levels of Oxybutynin and N-Desethyl-Oxybutynin at Day 2 Post-dose | Cerebral spinal fluid levels of Oxybutynin and N-Desethyl-Oxybutynin (metabolite of Oxybutynin) at Day 2 Post-dose. Cerebral spinal fluid is the fluid that surrounds the spinal cord and the inside of the brain. Samples were drawn from patients who received Oxybutynin IR. | Day 2 Post-Dose | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Plasma Levels of Sanctura XR® at Day 10 Post-dose | Plasma levels of Sanctura XR® at Day 10 post-dose. Plasma is the liquid component of the blood in which the blood cells are suspended. Plasma samples were collected from each patient and analyzed for the drug the patient received. | Day 10 Post-Dose | 
| Plasma Levels of Oxybutynin and N-Desethyl-Oxybutynin at Day 2 Post-dose | Plasma levels of Oxybutynin and N-Desethyl-Oxybutynin (metabolite of Oxybutynin) at Day 2 post-dose. Plasma is the liquid component of the blood in which the blood cells are suspended. Plasma samples were collected from each patient and analyzed for the drug the patient received. | Day 2 Post-Dose | 
| Change From Baseline in Total Recall Score as Measured by the Hopkins Verbal Learning Test-Revised (HVLT-R) up to Day 10 | Change from Baseline in Total Recall Score as Measured by the HVLT-R up to Day 10. The HVLT-R is an instrument used to measure verbal learning and memory (recognition and recall). It consists of 3 learning trials: free recall, delayed recall, and yes/no delayed recognition. The total recall score was the sum of 3 'free recall' learning trials, and reflects the patient's ability to learn. The total score ranges from 0 (no memory) to 36 (best memory). A positive change from baseline indicates improved memory and a negative change from baseline indicates worsened memory. | Baseline, 10 Days | 
| Change From Baseline in Delayed Recall Score as Measured by the HVLT-R up to Day 10 | Change from Baseline in Delayed Recall Score as Measured by the HVLT-R up to Day 10. The HVLT-R is an instrument used to measure verbal learning and memory (recognition and recall). It consists of 3 learning trials: free recall, delayed recall, and yes/no delayed recognition. The total recall score was the sum of 3 'free recall' learning trials, and reflects the patient's ability to learn. The total score ranges from 0 (no memory) to 12 (best memory). A positive change from baseline indicates improved memory. | Baseline, 10 Days | 
| Change From Baseline in Total Recall Score as Measured by the Brief Visuospatial Memory Test-Revised (BVMT-R) up to Day 10 | Change from Baseline in total recall score as measured by the BVMT-R up to Day 10. The BVMT-R is an instrument used to measure visual learning and memory (recognition and recall). It consists of 3 learning trials: free recall, delayed recall, and yes/no delayed recognition trial. The total recall score is the sum of 3 free recall learning trials, and reflects the patient's ability to learn. The total score ranges from 0 (no memory) to 36 (best memory). A positive change from baseline indicates improved memory. | Baseline, 10 Days | 
| Change From Baseline in Delayed Recall Score as Measured by the BVMT-R up to Day 10 | Change from Baseline in delayed recall score as measured by the BVMT-R up to Day 10. The BVMT-R is an instrument used to measure visual learning and memory (recognition and recall). It consists of 3 learning trials: free recall, delayed recall, and yes/no delayed recognition trial. The total recall score is the sum of 3 free recall learning trials, and reflects the patient's ability to learn. The total score ranges from 0 (no memory) to 12 (best memory). A positive change from baseline indicates improved memory. | Baseline, 10 Days |