Molecular Mediators of Physical Exercise and Carnosine Induced Effects in Patients With Preclinical and Early Stage Neurodegenerative Disease

Study Overview
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Brief Summary
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The purpose of this study is to investigate the beneficial effects of regular exercise and the impact of food supplement carnosine on cognitive, motoric and metabolic functions as well as on specific biologically active substances in volunteers with subjective (SCI) or mild (MCI) cognitive impairment, as well as in patients in early stages of Parkinson's disease. The investigators assume the immediate intervention-associated health benefit for volunteers.

Detailed Description
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Standard Operating Procedures for patient recruitment, data collection, data management, data analysis routinely used in Biomedical Research Center, Slovak Academy of Sciences, University Hospital Bratislava and Comenius University, Bratislava will be employed. Statistical analysis will be employed to address the primary and secondary objectives, as specified in the study protocol.

Official Title
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Molecular Mediators of Physical Exercise and Carnosine Induced Effects in Patients With Preclinical and Early Stage Neurodegenerative Disease

Conditions
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Healthy Volunteers, Mild Cognitive Impairment, Parkinson Disease, Subjective Cognitive Impairment

Intervention / Treatment
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* Behavioral: exercise
* Dietary Supplement: carnosine supplementation
* Behavioral: stretching
* Dietary Supplement: supplementation with placebo


Participation Criteria
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Eligibility 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

Ages Eligible for Study
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Minimum Age: 55 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: exercise and carnosine supplementation<br>exercise: participants will be subjected to 3 months supervised exercise intervention carnosine supplementation: participants will be instructed to take carnosine 2 times daily | Behavioral: exercise<br>* participants will be subjected to 3 months supervised exercise intervention<br>Dietary Supplement: carnosine supplementation<br>* participants will be instructed to take carnosine 2 times daily<br>|
| Experimental: exercise and supplementation with placebo<br>exercise: participants will be subjected to 3 months supervised exercise intervention supplementation with placebo: participants will be instructed to take placebo 2 times daily | Behavioral: exercise<br>* participants will be subjected to 3 months supervised exercise intervention<br>Dietary Supplement: supplementation with placebo<br>* participants will be instructed to take placebo 2 times daily<br>|
| Experimental: stretching controls and carnosine supplementation<br>stretching controls: participants will be subjected to 3 months supervised stretching program carnosine supplementation: participants will be instructed to take carnosine 2 times daily | Dietary Supplement: carnosine supplementation<br>* participants will be instructed to take carnosine 2 times daily<br>Behavioral: stretching<br>* participants will be subjected to 3 months supervised stretching program<br>|
| Experimental: stretching controls and supplementation with placebo<br>stretching controls: participants will be subjected to 3 months supervised stretching program supplementation with placebo: participants will be instructed to take placebo 2 times daily | Behavioral: stretching<br>* participants will be subjected to 3 months supervised stretching program<br>Dietary Supplement: supplementation with placebo<br>* participants will be instructed to take placebo 2 times daily<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| glucose tolerance | changes in glucose tolerance will be determined with oral glucose tolerance test (2h glucose, mmol/l) | up to 36 months | 
| learning/working memory | exercise related changes in learning/working memory will be determined with the aid of Addenbrook's cognitive test (maximum test score 100) | up to 36 months | 
| motoric functions - Berg Balance Scale | exercise related changes in motoric functions will be determined with the aid of Berg Balance Scale (maximum score 56) | up to 36 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| habitual physical activity | Habitual physical activity will be determined with accelerometers | up to 36 months | 
| physical fitness | Submaximal aerobic capacity will be determined with one mile walk test | up to 36 months |