The Effect of Anticholinergics on Cognitive Function in the Elderly (ACE)

University of North Carolina (UNC)

Status and phase: Completed; Phase 4

Conditions: Cognitive Function; Urinary Bladder, Overactive; Mental Competency

Treatments: Drug: Trospium Chloride; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT01922115

13-1352

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 59 patients

Sex: Female

Ages: 50 to 99 years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

59 participants in 2 patient groups, including a placebo group

TROSPIUM CHLORIDE

Active Comparator group

Description:

Those with overactive bladder will be administered either a placebo or Sanctura XR extended release (Trospium chloride) for treatment (60 mg).

Treatment:

Drug: Trospium Chloride

PLACEBO

Placebo Comparator group

Description:

Subjects may be administered a placebo rather than the Sanctura XR (Trospium Chloride).

Treatment:

Drug: Placebo