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

Completed · Early Phase 1 · Has a placebo group

Conditions studied: Parkinson Disease

In brief

Safe and independent mobility at home and in the community requires control of walking while accomplishing other functional tasks. A hallmark of healthy control of walking is automaticity, defined as the ability of the nervous system to successfully coordinate movement with minimal use of attention-demanding executive resources \[1\]. Recent evidence indicates that walking disorders are often characterized by a shift in the locomotor control strategy from healthy automaticity to compensatory executive control. This shift is potentially detrimental to walking performance as an executive control strategy is not optimized for locomotor control and it places excessive demands on a limited pool of cognitive reserve. Here, the investigators hypothesize that walking automaticity, as measured by the prefrontal cortex activity while walking, will be improved by donepezil (a cholinesterase inhibitor).

Key facts

Study ID

NCT03599726

Run by

Oregon Health and Science University

People needed

20

Starts

2018-07-30

Expected to finish

2019-07-30

Last updated by the study team

2020-05-11

Who can join

Age: 50 and older, up to 90. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Oregon Health & Science University — Portland, Oregon, United States

Full record on ClinicalTrials.gov

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