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Completed

NCT Number: NCT00912808

Cholinergic Augmentation in Frequently Falling Subjects With Parkinson's Disease

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.

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Key information

Conditions

Parkinson's Disease Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Movement Disorders Nervous System Diseases Neurodegenerative Diseases Parkinson Disease Parkinsonian Disorders Synucleinopathies

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Donepezil

Drug

donepezil, 5 mg, capsule, once a day, 3 weeks

Other names: aricept

Sugar Pill (placebo)

Drug

sugar pill, one capsule, once a day, 3 weeks

Primary outcomes

  1. Fall Frequency Per Day

    Time frame: 6 weeks

    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.

Secondary outcomes

  1. Frequency of Near Falls Per Day

    Time frame: 6 weeks

    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.

Sponsors and collaborators

Lead sponsor

Oregon Health and Science University

Other

Registry information

Official study title

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

Important dates

Study start
2005
Primary completion
2009
Study completion
2009
First posted
Jun 3, 2009
Registry last updated
May 8, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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