Cholinergic Augmentation in Frequently Falling Subjects With Parkinson's Disease

Parkinson's Disease Clinical Trial

Official title:

A Study of Cholinergic Augmentation in Frequently Falling Subjects With Parkinson's

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00912808
• Other study ID #: e1784
• Status: Completed
• Phase: N/A
• Start date: October 2005
• Est. completion date: February 2009

Study information

• Verified date: April 2018
• Source: Oregon Health and Science University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to find out if a medication that increases levels of a brain chemical called acetylcholine will improve balance and reduce falls in patients with parkinson's disease who have the problem of very poor balance and are frequently falling or nearly falling on a daily basis. Donepezil, a drug approved for the treatment of Alzheimer's dementia, will reduce falls in subjects with Parkinson's disease and balance impairment.

Description:

This trial is a double-blinded cross-over design comparing donepezil with placebo in 40 subjects with idiopathic Parkinson's disease who report frequent falls or near falls (>2/week). The purpose of this study is to find out if a medication that increases levels of a brain chemical called acetylcholine will improve balance and reduce falls in patients with parkinson's disease who have the problem of very poor balance and are frequently falling or nearly falling on a daily basis. Donepezil, a drug approved for the treatment of Alzheimer's dementia, will reduce falls in subjects with Parkinson's disease and balance impairment.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 23
• Est. completion date: February 2009
• Est. primary completion date: February 2009
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years and older

Eligibility

Inclusion Criteria:

• Age over 21

• Diagnosis of Parkinson's disease

• Treated with dopaminergic medication for at least 1 year

Exclusion Criteria:

• Must be ambulatory (can use walker or cane)

• No obvious remediable cause of falls

• Falls are on basis of non-CNS etiologies (cardiogenic, orthopedic, peripheral neuropathy, etc)

• Dementia present (MMSE < 25)

• Not taking cholinergic or anticholinergic medications 10 days prior to screening visit

• No Warfarin use

Related Conditions & MeSH terms

• Parkinson Disease
• Parkinson's Disease

Intervention

Drug:
• Donepezil
donepezil, 5 mg, capsule, once a day, 3 weeks
• Sugar Pill (placebo)
sugar pill, one capsule, once a day, 3 weeks

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Oregon Health and Science University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fall Frequency Per Day	The primary outcomes were fall frequency determined using daily event recording by the subjects onto postcards which accumulated data for six weeks per phase. Falls were defined as landing on the floor. Fall frequency is the number of reported falls divided by the number of days reported. Postcards were mailed back to the investigator weekly.	6 weeks
Secondary	Frequency of Near Falls Per Day	The secondary outcome was near fall frequency determined using daily event recording by the subjects onto postcards which accumulated data for six weeks per phase. Near falls were defined as a fall that did not land on the floor (for example grabbing a handrail or a table). Near fall frequency is the number of reported near falls divided by the number of days reported. Postcards were mailed back to the investigator weekly.	6 weeks