Remote Ischemic Conditioning of the Human Brain in Dementia Patients

Study Overview
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Brief Summary
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The study investigates the incidence of remote ischemic conditioning in mild cognitive impairment and dementia patients

Detailed Description
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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.

Official Title
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Remote Ischemic Conditioning of the Human Brain in Dementia Patients (RICBDE): Protocol for a Crossover Non-pharmaceutical Intervention Study

Conditions
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Mild Cognitive Impairment, Dementia, Intermittent Claudication

Intervention / Treatment
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* Behavioral: Leg ischemia


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Clinical diagnosis of mild cognitive impairment Clinical diagnosis of mild dementia Clinical diagnosis of moderate dementia Peripheral arteriopathy Exclusion Criteria: Clinical diagnosis of severe dementia Not being able to follow the exercise program for more than two days for any reason

Ages Eligible for Study
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Minimum Age: 65 Years
Maximum Age: 95 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Group 90 individuals, baseline assessment before intervention<br>Baseline Cognitive status assessment | |
| Experimental: Remote ischemic condition of the brain<br>Intermittent claudication induction on a daily basis for 1 month | Behavioral: Leg ischemia<br>* potential neuroprotection of ischemia/reperfusion of a peripheral organ or tissue against cerebral I/R injury<br>|
| No Intervention: Late cognitive assessment<br>Late cognitive status assessment 6 months later | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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) | Baseline, 1 month, 12 months | 
| Electroencephalography recording | Changes in Electroencephalography (EEG), resting state | Baseline, 1 month, 6 months |