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Cholinergic Neurotransmission in Mobility and Cognition in Parkinson Disease

NCT ID: NCT03840837

Last Updated: 2023-12-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

31 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-05-02

Study Completion Date

2020-04-01

Brief Summary

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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.

Detailed Description

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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).

Conditions

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Parkinson Disease Parkinson Disease Dementia

Keywords

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cognitive impairment Parkinson disease dementia wearable sensor gait analysis rivastigmine cholinesterase inhibitor

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SEQUENTIAL

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).
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Arm 1: baseline only (cross-sectional)

At baseline, all 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). In other words, all participants will be part of arm 1.

Group Type NO_INTERVENTION

No interventions assigned to this group

Arm 2: rivastigmine (longitudinal)

As study intervention, a subgroup of 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. For the arm 2 subgroup of participants, the same assessment that was performed at baseline (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.

Group Type EXPERIMENTAL

Rivastigmine transdermal patch

Intervention Type DRUG

Titration of transdermal rivastigmine, as per arm description.

Interventions

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Rivastigmine transdermal patch

Titration of transdermal rivastigmine, as per arm description.

Intervention Type DRUG

Other Intervention Names

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Exelon transdermal patch

Eligibility Criteria

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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).
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute on Aging (NIA)

NIH

Sponsor Role collaborator

University of Maryland, Baltimore

OTHER

Sponsor Role lead

Responsible Party

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F. Rainer von Coelln, MD

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Rainer von Coelln, Dr. med.

Role: PRINCIPAL_INVESTIGATOR

University of Maryland, Baltimore

Locations

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University of Maryland School of Medicine, Dept. of Neurology

Baltimore, Maryland, United States

Site Status

Countries

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United States

Other Identifiers

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3P30AG028747-13S3

Identifier Type: NIH

Identifier Source: secondary_id

View Link

HP-00084074

Identifier Type: -

Identifier Source: org_study_id