Sanctura Muscarinic Receptor Antagonist Resists Transport (SMART) Trial

• Status: Completed
• Trial end date: 2009-08-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Allergan
• Treatments: Trospium chloride

Criteria

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