Cholinergic Neurotransmission in Mobility and Cognition in Parkinson Disease

Purpose

This is a single-site, single-group open label 3-month 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). Study participants will be treated with rivastigmine for 12 weeks, and the effect of this treatment on gait measures and cognitive measures will be analyzed. 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.

Condition

  • Parkinson Disease

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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).
  • Patient is taking a cholinesterase inhibitor (donepezil, rivastigmine, galantamine).
  • Patient has undergone deep brain stimulation surgery, focused ultrasound, or other forms of stereotactic neurosurgical intervention.

Study Design

Phase
Phase 4
Study Type
Interventional
Intervention Model
Single Group Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Rivastigmine (transdermal) patch
At baseline, participants will undergo instrumented gait/balance testing, using a wearable sensor (Dynaport MT), and cognitive testing, using a computerized cognitive test battery (NeuroTrax Mild Cognitive Impairment & Early Dementia Battery by MindStreams). As study intervention, participants will then be treated with transdermal rivastigmine patch 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 patient on a stable dose of transdermal rivastigmine.
  • Drug: Rivastigmine transdermal patch
    Titration of transdermal rivastigmine, as per arm description.
    Other names:
    • Exelon transdermal patch

Recruiting Locations

University of Maryland School of Medicine, Dept. of Neurology
Baltimore, Maryland 21201
Contact:
Rainer von Coelln, Dr. med.
410-328-7809
rvoncoelln@som.umaryland.edu

More Details

NCT ID
NCT03840837
Status
Recruiting
Sponsor
University of Maryland

Study Contact

Rainer von Coelln, Dr. med.
410-328-7809
rvoncoelln@som.umaryland.edu

Detailed Description

This is a single-site, single-group 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.

Patients with idiopathic Parkinson disease (PD) and mild to moderate cognitive deficits will be enrolled. At baseline, 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). Participants 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. The investigatorswill also analyze change in iTUG measures and cognitive measures between baseline and follow-up (in other words, before and after rivastigmine treatment).