The Effect of Anticholinergics on Cognitive Function in the Elderly
| Status: | Completed |
|---|---|
| Conditions: | Cognitive Studies, Cognitive Studies, Overactive Bladder |
| Therapuetic Areas: | Gastroenterology, Psychiatry / Psychology |
| Healthy: | No |
| Age Range: | 50 - 99 |
| Updated: | 4/21/2016 |
| Start Date: | June 2013 |
| End Date: | June 2015 |
The Effect of Anticholinergics on Cognitive Function in the Elderly: a Randomized Controlled Trial
Anticholinergic medication is used to treat overactive bladder (OAB). A known side effect of
this medication is cognitive dysfunction. OAB is more prevalent in the elderly population -
a group that also has a higher baseline risk of cognitive dysfunction. Our objective is to
evaluate the effect of an anticholinergic medication on cognitive function in elderly women.
Subjects will be randomized to:1) trospium chloride or 2) placebo. There are three aims: 1)
To evaluate changes in cognitive function in elderly women taking trospium versus placebo,
using validated cognitive assessment tests. 2) To develop a useful battery of cognitive
screening tests for monitoring the cognitive safety of OAB management. 3) To understand how
the timing of cognitive changes relates to the timing of improvement in OAB symptoms. The
investigators will recruit 60 women aged ≥ 50 with the diagnosis of OAB. Cognitive
assessments will be performed at baseline and Week 1 and 4 after drug initiation using
paper-based validated questionnaires. OAB improvement will be assessed with validated
questionnaires.
this medication is cognitive dysfunction. OAB is more prevalent in the elderly population -
a group that also has a higher baseline risk of cognitive dysfunction. Our objective is to
evaluate the effect of an anticholinergic medication on cognitive function in elderly women.
Subjects will be randomized to:1) trospium chloride or 2) placebo. There are three aims: 1)
To evaluate changes in cognitive function in elderly women taking trospium versus placebo,
using validated cognitive assessment tests. 2) To develop a useful battery of cognitive
screening tests for monitoring the cognitive safety of OAB management. 3) To understand how
the timing of cognitive changes relates to the timing of improvement in OAB symptoms. The
investigators will recruit 60 women aged ≥ 50 with the diagnosis of OAB. Cognitive
assessments will be performed at baseline and Week 1 and 4 after drug initiation using
paper-based validated questionnaires. OAB improvement will be assessed with validated
questionnaires.
Inclusion Criteria:
- Female 50 or older
- Diagnosis of OAB (ICS definition)
- English literacy
- Ability to swallow oral medication
- Cognitive ability to give consent
Exclusion Criteria:
- Dementia/Depression/Delirium
- Current anticholinergic use (requires 2 week washout period)
- Current cholinesterase
- Urinary or gastric retention
- Severe decreased gastrointestinal motility
- Uncontrolled narrow-angle glaucoma
- Myasthenia gravis
- Diagnosis fo renal impairment (creatinine clearance <30 mL/min)
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