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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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12 December 2020 |
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Main ID: |
NCT03330470 |
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Date of registration:
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17/10/2017 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Molecular Mediators of Physical Exercise and Carnosine Induced Effects in Patients With Preclinical and Early Stage Neurodegenerative Disease
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Scientific title:
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Molecular Mediators of Physical Exercise and Carnosine Induced Effects in Patients With Preclinical and Early Stage Neurodegenerative Disease |
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Date of first enrolment:
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January 1, 2017 |
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Target sample size:
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100 |
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Recruitment status: |
Recruiting |
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URL:
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https://clinicaltrials.gov/show/NCT03330470 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Basic Science. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
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Phase:
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N/A
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Countries of recruitment
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Slovakia
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Taiwan
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Contacts
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Name:
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Barbara Ukropcová, Assoc. Prof., MD, PhD |
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Address:
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Telephone:
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+421 2 32295 2261 |
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Email:
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barbara.ukropcova@savba.sk |
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Affiliation:
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Name:
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Barbara Ukropcová, Assoc. Prof., MD, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Biomedical Research Center, Slovak Academy of Sciences, |
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Name:
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Peter Valkovic, Prof., MD, PhD |
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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 Hospital Bratislava, Comenius University, Bratislava, |
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Name:
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Jozef Ukropec, DrSc, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Biomedical Research Center, Slovak Academy of Sciences, |
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Name:
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Barbara Ukropcová, Assoc. Prof., MD, PhD |
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Address:
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Telephone:
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+421 2 32295 2261 |
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Email:
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barbara.ukropcova@savba.sk |
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Affiliation:
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Name:
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Peter Turcáni, Prof., MD, PhD |
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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 Hospital Bratislava, Comenius University, Bratislava, |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Signed informed consent
- Age 55 - 80 years
- Presence of Subjective Cognitive Impairment (SCI), Mild Cognitive Impairment (MCI) or
early stage of Parkinson's Disease (Hoehn-Yahr 1st-2nd stage), assessed by experienced
neurologist
Exclusion Criteria:
- Serious systemic cardiovascular, hepatic, renal disease, cancer
- Lack of compliance
Age minimum:
55 Years
Age maximum:
80 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Parkinson Disease
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Healthy Volunteers
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Mild Cognitive Impairment
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Subjective Cognitive Impairment
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Intervention(s)
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Dietary Supplement: carnosine supplementation
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Behavioral: exercise
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Behavioral: stretching
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Dietary Supplement: supplementation with placebo
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Primary Outcome(s)
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motoric functions - Berg Balance Scale
[Time Frame: up to 36 months]
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learning/working memory
[Time Frame: up to 36 months]
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glucose tolerance
[Time Frame: up to 36 months]
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Secondary Outcome(s)
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habitual physical activity
[Time Frame: up to 36 months]
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physical fitness
[Time Frame: up to 36 months]
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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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