Sanctura Muscarinic Receptor Antagonist Resists Transport (SMART) Trial

Allergan

Status and phase

Completed

Phase 4

Conditions

Elderly

Overactive Bladder

Pharmacokinetics

Treatments

Drug: Trospium Chloride

Study type

Interventional

Funder types

Industry

Identifiers

NCT00863551

MA-SXR-09-001

SMART Trial (Other Identifier)

Details and patient eligibility

About

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.

Enrollment

12 patients

Sex

All

Ages

65 to 75 years old

Volunteers

No Healthy Volunteers

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