A Study to Assess the Cognitive Effects of Fesoterodine in Elderly Subjects

Pfizer

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: Placebo; Drug: 8mg fesoterodine; Drug: 4mg fesoterodine; Drug: alprazolam 1mg

Study type: Interventional

Funder types: Industry

Identifiers

NCT01161472

A0221086

Details and patient eligibility

About

The study is designed to evaluate elements of cognitive function in subjects receiving either fesoterodine or alprazolam.

Full description

Evaluation of cognitive function

Enrollment: 20 patients

Sex: All

Ages: 65 to 85 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Adult healthy volunteers 65 years and over with minimum MMSE of 26

Exclusion criteria

• Prohibited concomitant medications
• Confounding medical conditions
• Clinically significant comorbid diseases
• Hypersensitivity or contraindications to fesoterodine or active control

Trial design

20 participants in 4 patient groups, including a placebo group

4mg fesoterodine

Experimental group

Treatment:

Drug: 4mg fesoterodine

fesoterodine 8mg

Experimental group

Treatment:

Drug: 8mg fesoterodine

1mg alprazolam

Active Comparator group

Treatment:

Drug: alprazolam 1mg

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo