Improving Walking Automaticity in Parkinson's Disease: Levodopa or Donepezil

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT03599726
• Date of registration: 29/06/2018
• Prospective Registration: Yes
• Primary sponsor: Oregon Health and Science University
• Public title: Improving Walking Automaticity in Parkinson's Disease: Levodopa or Donepezil
• Scientific title: Improving Walking Automaticity in Parkinson's Disease: Levodopa or Donepezil
• Date of first enrolment: July 30, 2018
• Target sample size: 20
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT03599726
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Crossover Assignment. Primary purpose: Basic Science. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
• Phase: Early Phase 1

Countries of recruitment

United States

Contacts

• Name: Martina Mancini, PhD
• Affiliation: Oregon Health and Science University

Key inclusion & exclusion criteria

Inclusion Criteria:

- Subjects must be able to stand unassisted for a minute and to walk continuously for 2
minutes without assistance or assistive devices.

- Diagnosis of idiopathic Parkinson's disease with sensitivity to levodopa and
off-medication Hoehn & Yahr scores of III-IV.

- Subjects must be currently taking levodopa, and not already taking donepezil

- The subjects must be able to appreciate the purpose of the research, give informed
consent to participate, be able to cooperate with the testing and be compliant with
taking the experimental medications.

Exclusion Criteria:

- Other factors affecting gait (hip replacement, musculoskeletal disorder, uncorrected
vision or vestibular problem), or an inability to stand or walk for 2 minutes at a
time. Major depression, hallucinations or other psychiatric disturbances will be
exclusions.

- Medical problems that might be worsened by donepezil are exclusion criteria and
include tachycardia, bradycardia, arrhythmias, and peptic ulcer disease.

- Use of anticholinergics for parkinsonism, cholinesterase inhibitors for cognitive
problems, bladder antispasmodics for urinary urgency or tricyclic antidepressants for
depression are contraindications.



Age minimum: 50 Years
Age maximum: 90 Years
Gender: All

Health Condition(s) or Problem(s) studied

Parkinson Disease

Intervention(s)

Drug: Donepezil

Drug: Placebo

Primary Outcome(s)

Oxygenated Hemoglobin levels in the prefrontal cortex while walking (microM). [Time Frame: 43 days]

Secondary Outcome(s)

Stride time variability of gait (%). [Time Frame: 43 days]

Stride length (m) [Time Frame: 43 days]

Gait speed (m/s) [Time Frame: 43 days]

Turning duration (s) [Time Frame: 43 days]

Turning velocity (degrees/s) [Time Frame: 43 days]

Secondary ID(s)

eIRB 17805

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Medical Research Foundation, Oregon