Sanctura Muscarinic Receptor Antagonist Resists Transport (SMART) Trial

Completed · Phase 4

Conditions studied: Elderly, Pharmacokinetics, Overactive Bladder

In brief

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.

Key facts

Study ID

NCT00863551

Run by

Allergan

People needed

12

Starts

2009-04-01

Expected to finish

2009-08-01

Last updated by the study team

2016-02-26

Who can join

Age: 65 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Study site — Glendale, California, United States

Full record on ClinicalTrials.gov

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