Clinical trial

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

Name
HP-00084074
Description
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.
Trial arms
Trial start
2019-05-02
Estimated PCD
2020-04-01
Trial end
2020-04-01
Status
Completed
Phase
Early phase I
Treatment
Rivastigmine transdermal patch
Titration of transdermal rivastigmine, as per arm description.
Arms:
Arm 2: rivastigmine (longitudinal)
Other names:
Exelon transdermal patch
Size
31
Primary endpoint
Timed-Up-and-Go (TUG) duration [s]
Data analysis will be completed within 6 months of completing study enrollment.
NeuroTrax Executive Function score
Data analysis will be completed within 6 months of completing study enrollment.
Eligibility criteria
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).
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'NON_RANDOMIZED', 'interventionModel': 'SEQUENTIAL', 'interventionModelDescription': 'All participants perform a baseline assessment (arm 1 - cross-sectional). A subgroup of participants (based on physician and participant choice) proceed to a 12-week treatment phase with the study drug (transdermal rivastigmine) and subsequent follow-up assessment (arm 2 - longitudinal).', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 31, 'type': 'ACTUAL'}}
Updated at
2023-12-20

1 organization

1 product

2 indications