Sanctura Muscarinic Receptor Antagonist Resists Transport (SMART) Trial



Status:Completed
Conditions:Overactive Bladder
Therapuetic Areas:Gastroenterology
Healthy:No
Age Range:65 - 75
Updated:4/21/2016
Start Date:April 2009
End Date:August 2009

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Trial Summary
Trial Overview
Inclusion Criteria

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.


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
We found this trial at
1
site
Clinical Trial Facility in Glendale California
Glendale, California 91206
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mi
from
Glendale, CA
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