NCT00863551CompletedPhase 4
Sanctura Muscarinic Receptor Antagonist Resists Transport (SMART) Trial
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- Allergan
- Enrollment
- 12
- Primary Endpoint
- Cerebral Spinal Fluid Levels of Trospium at Day 10, Hour 5
Study Overview
Brief Summary
This study evaluates the penetration through the blood-brain-barrier of trospium chloride at plasma steady state (Day 10) in elderly subjects with overactive bladder symptoms. Trospium levels in cerebrospinal fluid (CSF) and peak and trough plasma levels will be measured. Baseline and day 10 post-dose neurocognitive testing will be compared using a reliable change index to assess if any study subject shows evidence of a clinically and statistically significant change in memory.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 65 Years to 75 Years (Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Male or female, 65-75 years of age without evidence of memory impairment
- •Subject has overactive bladder symptoms but otherwise healthy
- •Non-smoker (refrained from any tobacco usage, including smokeless tobacco, nicotine patches, etc., for 6 months prior to the screening visit)
- •Weight within normal range
- •Ability to follow study instructions and likely to complete all required visits
Exclusion Criteria
- •Residual urine within bladder greater than 4 ounces
- •Moderate or severe memory impairment
- •Bleeding disorder
- •Blood-thinning agents
- •Concurrent overactive bladder medication
- •Concurrent dementia drugs: Aricept (donepezil), Namenda (memantine), Cognex (tacrine), Exelon (rivastigmine), Razadyne (galantamine), galantamine or similar drugs for dementia
- •Chronic kidney failure
- •Abdominal bypass surgery for obesity
Arms & Interventions
Trospium Chloride Extended Release, 60 mg
Experimental
Trospium Chloride Extended Release, 60 mg
Intervention: Trospium Chloride (Drug)
Outcomes
Primary Outcomes
Cerebral Spinal Fluid Levels of Trospium at Day 10, Hour 5
Time Frame: Day 10, Hour 5
Cerebral spinal fluid levels of Trospium at day 10, hour 5. Cerebral spinal fluid was collected from each patient.
Secondary Outcomes
- Percentage of Study Subjects With No Clinically Significant Effect on Neurocognitive Function as Measured by the Brief Visuospatial Memory Test-Revised (BVMT-R) Total Score at Day 10 Post-Dose(Day 10)
- Percentage of Study Subjects With No Clinically Significant Effect on Neurocognitive Function Total Recall Score as Measured by the Hopkins Verbal Learning Test-Revised (HVLT-R) at Day 10 Post-Dose(Day 10)
- Percentage of Study Subjects With No Clinically Significant Effect on Neurocognitive Function as Measured by the Brief Visuospatial Memory Test-Revised (BVMT-R) Delayed Recall Score at Day 10 Post-Dose(Day 10)
- Percentage of Study Subjects With No Clinically Significant Effect on Neurocognitive Function Delayed Recall Score as Measured by the Hopkins Verbal Learning Test-Revised (HVLT-R) at Day 10 Post-Dose(Day 10)
Investigators
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