The Effect of Donepezil on Gait and Balance in Parkinson's Disease

NCT01521117 | Completed Phase 4 Results DMC FDA Drug

• 1 other identifier: OHSU-7363
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

Brief Summary

This study involves Parkinson's disease (PD). Symptoms include slow movement, tremor, and muscle rigidity. Current medications for the treatment of PD do not improve gait and balance difficulties in individuals with PD. Donepezil (study drug) has been found to reduce falls in individuals with PD. The mechanism in which this reduction of falls occurs is unclear. The investigators study will look at what aspects of gait and balance are improved by the study drug. The study drug is not approved to treat PD in the United States or other countries because we do not know enough about it.

Conditions

Parkinson's Disease

Keywords

donepezil; parkinson's disease; balance; cholinesterase inhibitor

Outcome Measures

Primary Outcomes (2)

• Sensory Organization Test - Composite Score

  Balance was measured using the Sensory Organization test (SOT) on the NeuroCom Balance Master Clinical Research System platform (Neurocom International, Inc), which tests sway in 6 conditions, eyes open, eyes closed, and a moving visual surround first with a stable platform then with a moving platform. Center of Pressure (CoP) was calculated from the recordings. Forces and moments were recorded at 100Hz sampling frequency. A change score from the beginning of each treatment phase (placebo or active drug) to the end of the treatment phase. The SOT is scored on an interval scale with the highest possible score of 100 indicating no sway at all. The lowest possible score of 0 indicates the trial was stopped due to an impending fall. Higher scores are indicative of better balance (greater stability).

  Change from Day 1 of each treatment phase to Day 42 of each treatment phase

• Sensory Organization Test (SOT) - Condition 4 (Eyes Open, Moving Surround, Stable Platform).

  Condition 4 of the Sensory Organization Test. The participants eyes are open as the surround moves and the platform remains stable. A change score from the beginning of each treatment phase (placebo or active drug) to the end of the treatment phase. The SOT is scored on an interval scale with the highest possible score of 100 indicating no sway at all. The lowest possible score of 0 indicates the trial was stopped due to an impending fall. Higher scores are indicative of better balance (greater stability).

  Change from Day 1 of each treatment phase to Day 42 of each treatment phase

Secondary Outcomes (1)

• Trails B - A

  Change from Day 1 of each treatment phase to Day 42 of each treatment phase

Study Arms (2)

Donepezil, Then Placebo

EXPERIMENTAL

Donepezil 5 mg a day for weeks 1 - 3, if tolerated increased to 10 mg a day for weeks 4 - 6. After a washout period of 4 weeks, placebo 5 mg a day for weeks 1 - 3, if tolerated increased to 10 mg a day for weeks 4 - 6.

Drug: Donepezil; Drug: Placebo

Placebo, Then Donepezil

EXPERIMENTAL

Placebo 5 mg a day for weeks 1 - 3, if tolerated increased to 10 mg a day for weeks 4 - 6. After a washout period of 4 weeks, donepezil 5 mg a day for weeks 1 - 3, if tolerated increased to 10 mg a day for weeks 4 - 6.

Drug: Donepezil; Drug: Placebo

Interventions

Donepezil DRUG

Use 1 capsule (5 mg) of donepezil once per day for first 21 days than donepezil 10mg qday for 21 days.

Also known as: Aricept

Donepezil, Then Placebo; Placebo, Then Donepezil

Placebo DRUG

Use 1 capsule (5 mg) once per day for first 21 days than 10mg qday for 21 days.

Also known as: Sugar Pill

Donepezil, Then Placebo; Placebo, Then Donepezil

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Idiopathic Parkinson's disease, defined by the UK Brain Bank criteria, with a Hoehn and Yahr score of 2 to 4
• Treated with levodopa for at least a year and on a stable antiparkinsonian regimen for at least one month
• Abnormal computerized dynamic posturography (CDP) on screening defined as a composite score below 65 (range 1-100)

You may not qualify if:

• Dementia defined by MMSE less than 27
• Other medical conditions other than PD affecting balance or gait as determined by the investigators
• Unable to stand unassisted for 30 minutes
• Current use of an acetylcholinesterase inhibitors or drugs with known anticholinergic properties
• Medical or psychiatric co-morbidities that may interfere with compliance or might place subject in danger as determined by the investigators

Sponsors & Collaborators

• Oregon Health and Science University: lead

Study Sites (1)

Parkinson's Center of Oregon - Oregon Health and Science University

Portland, Oregon, 97239, United States

Location

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

Results Point of Contact

• Title: Amie Hiller, MD
• Organization: Oregon Health & Science University

peterami@ohsu.edu

503 721 1091

Study Officials

• Seth Kareus, MD

  Movement Disorders Program - Parkinson's Center of Oregon - Oregon Health and Science University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 12, 2012
• First Posted: January 30, 2012
• Study Start: December 1, 2011
• Primary Completion: April 1, 2012
• Study Completion: July 1, 2012
• Last Updated: October 5, 2021
• Results First Posted: August 27, 2021

Record last verified: 2021-09

Locations

US (1)