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| Name | Class |
|---|---|
| Greek Alzheimer's Association and Related Disorders | OTHER |
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The study investigates the incidence of remote ischemic conditioning in mild cognitive impairment and dementia patients
The investigators will study the potential neuroprotection of ischemia/reperfusion (I/R) of a peripheral organ or tissue against cerebral I/R injury in people with mild cognitive impairment as well as early and middle stage dementia.
This crossover study will be held with individuals suffering from peripheral arteriopathy that can cause intermittent claudication after structured exercise, thus inducing extensive transient leg's ischemia.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 90 individuals, baseline assessment before intervention | No Intervention | Baseline Cognitive status assessment | |
| Remote ischemic condition of the brain | Experimental | Intermittent claudication induction on a daily basis for 1 month |
|
| Late cognitive assessment | No Intervention | Late cognitive status assessment 6 months later |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Leg ischemia | Behavioral | potential neuroprotection of ischemia/reperfusion of a peripheral organ or tissue against cerebral I/R injury |
|
| Measure | Description | Time Frame |
|---|---|---|
| Measurements to Assess General Cognitive Function | Change in Mini Mental State Examination (minimum value 10 - maximum value 30, higher scores mean a better outcome) | Baseline, 1 and 6 months |
| Neuropsychological Assessment | Change Test (higher scores mean a better outcome) | Baseline, 1 and 6 months |
| Changes in Functional Cognitive State | Global Deterioration Scale (values 1-7, higher scores mean a worse outcome) | Baseline, 1 and 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| NeuroImaging | Magnetic Resonance Imaging (MRI) (white matter hyperintensities volume) | baseline, 1 month, 6 months |
| Neurophysiology | Changes in Event-Related Potential (ERP) (oddball paradigm, auditory ERPs) |
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Inclusion Criteria:
Exclusion Criteria:
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Individual participant data will be available. Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices) will be shared. Study Protocol and Informed Consent Form will also be available. Data will be available (start and end dates) immediately following publication, No end date, with Investigations whose proposed use of the data has been approved by an independent review committee identified for this purpose, and for any purpose types of analysis.
Data will be available (start and end dates) immediately following publication, No end date
To gain access, data requestors will need to sign a data access agreement.
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| ID | Term |
|---|---|
| D060825 | Cognitive Dysfunction |
| D003704 | Dementia |
| D007383 | Intermittent Claudication |
| ID | Term |
|---|---|
| D003072 | Cognition Disorders |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| D001927 | Brain Diseases |
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| Baseline, 1 month, 12 months |
| Electroencephalography recording | Changes in Electroencephalography (EEG), resting state | Baseline, 1 month, 6 months |
| D002493 |
| Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D058729 | Peripheral Arterial Disease |
| D016491 | Peripheral Vascular Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |