Cholinergic Augmentation in Frequently Falling Subjects With Parkinson's Disease

NCT00912808 | Completed Results

• 1 other identifier: e1784
• Study Type: interventional
• Target: 23
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Parkinson's Disease

Keywords

parkinsons disease; falling

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Frequency of Near Falls Per Day

  6 weeks

Study Arms (2)

Donepezil

EXPERIMENTAL

Drug: Donepezil

Sugar Pill

PLACEBO COMPARATOR

Drug: Sugar Pill (placebo)

Interventions

Donepezil DRUG

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

Also known as: aricept

Donepezil

Sugar Pill (placebo) DRUG

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

Sugar Pill

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age over 21
• Diagnosis of Parkinson's disease
• Treated with dopaminergic medication for at least 1 year

You may not qualify if:

• 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

Sponsors & Collaborators

• Oregon Health and Science University: lead

MeSH Terms

Conditions

Parkinson Disease

Interventions

Donepezil; Sugars

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Intervention Hierarchy (Ancestors)

Indans; Indenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Polycyclic Compounds; Carbohydrates

Limitations and Caveats

Small number of subjects and lack of objective measurement to quantify falls. The most difficult condition to exclude was co-existing freezing of gait.

Results Point of Contact

• Title: Kathryn Chung, MD
• Organization: Oregon Health & Science University

chungka@ohsu.edu

503 220 8262

Study Officials

• Kathryn Chung, MD

  Oregon Health and Science University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor - Neurology

Study Record Dates

• First Submitted: June 2, 2009
• First Posted: June 3, 2009
• Study Start: October 1, 2005
• Primary Completion: February 1, 2009
• Study Completion: February 1, 2009
• Last Updated: May 8, 2018
• Results First Posted: August 15, 2011

Record last verified: 2018-04

Data Sharing

• IPD Sharing: Will not share