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NCT03599726 · ClinicalTrials.gov registry record · Early Phase 1

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

A Early Phase 1 study, sponsored by Oregon Health and Science University.

Completed
Registry status
Early Phase 1
Development phase
20
Enrollment target

NCT03599726: Completed Early Phase 1 study, sponsored by Oregon Health and Science University.

NCT03599726 is a Early Phase 1 study that has completed, run by Oregon Health and Science University. The registered enrollment target is 20 participants, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (62% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT03599726, a Early Phase 1 study, has completed, sponsored by Oregon Health and Science University.

COMPLETED
Registry status
Early Phase 1
Development phase
20 participants
Enrollment target

Study Summary

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).

Primary Outcome

Oxygenated hemoglobin changes during walking, compared to standing, will be quantified with a wireless functional near infrared spectroscopy (fNIRS). Subjects with PD will be tested while walking after 14 days of placebo and their regular dose of levodopa or after 14 days of donepezil (5 mg/day oral) and their regular dose of levodopa, with a two week wash out in between.

Interventions

  • DRUG Placebo
  • DRUG Donepezil

Trial Details

FieldValue
Enrollment Target 20 participants
Start Date 2018-07-30
Est. Completion 2019-07-30
Phase Early Phase 1

What the finished NCT03599726 record still lists

NCT03599726 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 20 participants, a relatively small participant target, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (62% lower).

The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.

NCT03599726 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT03599726 about?

NCT03599726 is a clinical study titled "Improving Walking Automaticity in Parkinson's Disease: Levodopa or Donepezil". 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-...

What is the current status of trial NCT03599726?

This trial is currently completed. It is a Early Phase 1 study. The enrollment target is 20 participants. The study started on 2018-07-30. Estimated completion is 2019-07-30.

What interventions are being tested in trial NCT03599726?

The interventions under investigation include: Placebo (DRUG), Donepezil (DRUG).

Who is sponsoring clinical trial NCT03599726?

This trial is sponsored by Oregon Health and Science University, which has 546 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT03599726's enrollment target sits among peer trials

20 1157th of 2000 higher than 709 of 2,000 other Early Phase 1 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Early Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT03599726, the US trial registry maintained by the National Library of Medicine. NCT03599726 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.