Cholinergic Neurotransmission in Mobility and Cognition in Parkinson Disease

NCT03840837 | Completed Phase 4 DMC FDA Drug

• 2 other identifiers: HP-000840743P30AG028747-13S3
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Parkinson Disease; Parkinson Disease Dementia

Keywords

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

Outcome Measures

Primary Outcomes (2)

• Timed-Up-and-Go (TUG) duration [s]

  Time participant needs to complete the TUG.

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

• NeuroTrax Executive Function score

  Result of the NeuroTrax computerized cognitive test of executive function.

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

Study Arms (2)

Arm 1: baseline only (cross-sectional)

NO INTERVENTION

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.

Arm 2: rivastigmine (longitudinal)

EXPERIMENTAL

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.

Drug: Rivastigmine transdermal patch

Interventions

Rivastigmine transdermal patch DRUG

Titration of transdermal rivastigmine, as per arm description.

Also known as: Exelon transdermal patch

Arm 2: rivastigmine (longitudinal)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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).

Sponsors & Collaborators

• University of Maryland, Baltimore: lead
• National Institute on Aging (NIA): collaborator

Study Sites (1)

University of Maryland School of Medicine, Dept. of Neurology

Baltimore, Maryland, 21201, United States

Location

MeSH Terms

Conditions

Parkinson Disease; Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Study Officials

• Rainer von Coelln, Dr. med.

  University of Maryland, Baltimore

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: 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).

Study Record Dates

• First Submitted: February 11, 2019
• First Posted: February 15, 2019
• Study Start: May 2, 2019
• Primary Completion: April 1, 2020
• Study Completion: April 1, 2020
• Last Updated: December 20, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)