Sanctura Muscarinic Receptor Antagonist Resists Transport (SMART) Trial

Condition(s) targeted: Elderly; Pharmacokinetics; Overactive Bladder

Intervention: Trospium Chloride (Drug)

Phase: Phase 4

Status: Not yet recruiting

Sponsored by: Allergan

Official(s) and/or principal investigator(s):
Medical Director, Study Director, Affiliation: Allergan

Overall contact:
Allergan Inc, Email: clinicaltrials@allergan.com

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: Treatment, Non-Randomized, Open Label, Single Group Assignment, Pharmacokinetics Study

Primary outcome: Mean concentration of trospium in cerebral spinal fluid at day 10, hour 5

Secondary outcome:

The proportion of study subjects with no clinically significant effect on neurocognitive function as measured by the Hopkins Verbal Learning test-Revised

The proportion of study subjects with no clinically significant effect on neurocognitive function as measured by the Brief Visuospatial Memory Test-Revised

Minimum age: 65 Years. Maximum age: 75 Years. Gender(s): Both.

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

Allergan Inc, Email: clinicaltrials@allergan.com

Glendale, California, United States

Starting date: April 2009
Ending date: September 2009
Last updated: March 16, 2009