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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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8 January 2024 |
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Main ID: |
NCT03840837 |
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Date of registration:
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11/02/2019 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Cholinergic Neurotransmission in Mobility and Cognition in Parkinson Disease
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Scientific title:
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Cholinergic Neurotransmission - A Common Underlying Mechanism of Cognitive and Gait Impairment in Parkinson Disease |
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Date of first enrolment:
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May 2, 2019 |
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Target sample size:
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31 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/ct2/show/NCT03840837 |
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Study type:
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Interventional |
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Study design:
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Allocation: Non-Randomized. Intervention model: Sequential Assignment. Primary purpose: Treatment. Masking: None (Open Label).
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Phase:
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Phase 4
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Countries of recruitment
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United States
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Contacts
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Name:
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Rainer von Coelln, Dr. med. |
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Address:
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Telephone:
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Email:
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Affiliation:
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University of Maryland, Baltimore |
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Key inclusion & exclusion 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).
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Parkinson Disease
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Parkinson Disease Dementia
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Intervention(s)
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Drug: Rivastigmine transdermal patch
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Primary Outcome(s)
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Timed-Up-and-Go (TUG) duration [s]
[Time Frame: Data analysis will be completed within 6 months of completing study enrollment.]
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NeuroTrax Executive Function score
[Time Frame: Data analysis will be completed within 6 months of completing study enrollment.]
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Secondary ID(s)
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HP-00084074
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3P30AG028747-13S3
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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