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Completed

NCT Number: NCT03840837

Cholinergic Neurotransmission in Mobility and Cognition in Parkinson Disease

This is a single-site non-randomized open label pilot study. The investigators will use accelerometer-based instrumented gait analysis and computerized cognitive testing to study the interaction of motor and cognitive dysfunction in Parkinson disease dementia (PDD), and the effect of rivastigmine on motor and cognitive performance. All study participants will be tested for motor and cognitive performance at baseline (arm 1). A subgroup of study participants will then be treated with rivastigmine for 12 weeks (arm 2), and the effect of this treatment on gait measures and cognitive measures will be analyzed at the follow-up visit 12 weeks after the baseline visit. Specifically, we will determine which components of motor and cognitive impairment are associated with each other, and which components of the two domains respond to rivastigmine-mediated stimulation of cholinergic neurotransmission.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

University of Maryland School of Medicine, Dept. of Neurology

Baltimore, Maryland, 21201, United States

About this study

This is a single-site non-randomized open label clinical trial in patients with Parkinson disease (PD) and mild to moderate cognitive deficits, designed to 1) identify associations between cognitive impairment and gait impairment, and 2) identify cognitive domains and gait measures that improve after 12 weeks of treatment with rivastigmine. Aim 1 will be addressed with a cross-sectional approach (arm 1, baseline only, all participants), and aim 2 will be addressed with a longitudinal interventional approach (arm 2, 12 week-treatment with rivastigmine, subgroup of participants).

Patients with idiopathic Parkinson disease (PD) and mild to moderate cognitive deficits amounting to PD dementia (PDD) will be enrolled. At baseline (arm 1), all participants will perform the timed-up-and-go test (TUG), wearing a light-weight sensor device strapped to the lower back with a neoprene belt. Participants will also complete a computerized cognitive test battery (NeuroTrax Mild Cognitive Impairment & Early Dementia Battery by MindStreams). A subgroup of participants (arm 2) will then be treated with transdermal rivastigmine for 12 weeks, with dose increases every 4 weeks and titration up to 13.3 mg/24h, if tolerated. The same assessment (quantitative gait testing and NeuroTrax computerized cognitive test battery) will be repeated after 12 weeks, with the participant on a stable dose of transdermal rivastigmine.

The investigators will analyze correlation of iTUG measures and cognitive measures at baseline (cross-sectional analysis). The investigators will also analyze change in iTUG measures and cognitive measures between baseline and follow-up for the subgroup of participants in arm 2 (in other words, before and after rivastigmine treatment; longitudinal analysis).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age ≥ 18 years.
  • Diagnosis of idiopathic Parkinson disease.
  • Mild to moderate cognitive impairment, as determined by a MoCA score of ≤ 25 and ≥ 10.
  • Patient passes the Evaluation to Sign Consent (ESC) or a legally authorized representative (LAR) is present at the time of enrollment and signs the informed consent form on behalf of the patient.
  • Patient is enrolled (or willing to be enrolled) in the University of Maryland Parkinson Disease and Movement Disorders Center PD Research Database (HP 42195)

Exclusion criteria

  • Advanced Parkinson disease (Hoehn & Yahr stage 5), with inability to walk unassisted.
  • Other medical condition(s) that significantly interfere(s) with gait and balance (e.g., advanced arthritis).

Treatment and study plan

Rivastigmine transdermal patch

Drug

Titration of transdermal rivastigmine, as per arm description.

Other names: Exelon transdermal patch

Primary outcomes

  1. Timed-Up-and-Go (TUG) duration [s]

    Time frame: Data analysis will be completed within 6 months of completing study enrollment.

    Time participant needs to complete the TUG.

  2. NeuroTrax Executive Function score

    Time frame: Data analysis will be completed within 6 months of completing study enrollment.

    Result of the NeuroTrax computerized cognitive test of executive function.

Sponsors and collaborators

Lead sponsor

University of Maryland, Baltimore

Other

Collaborators

  • National Institute on Aging (NIA)

Registry information

Official study title

Cholinergic Neurotransmission - A Common Underlying Mechanism of Cognitive and Gait Impairment in Parkinson Disease

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Feb 15, 2019
Registry last updated
Dec 20, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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