Remote Ischemic Conditioning of the Human Brain in Dementia Patients

Aristotle University Of Thessaloniki90 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Mild Cognitive Impairment Dementia Intermittent Claudication

Interventions

Leg ischemiaBEHAVIORAL

potential neuroprotection of ischemia/reperfusion of a peripheral organ or tissue against cerebral I/R injury

Eligibility

Sex: ALLMin age: 65 YearsMax age: 95 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Measurements to Assess General Cognitive Function

Change in Mini Mental State Examination (minimum value 10 - maximum value 30, higher scores mean a better outcome)

Time frame: Baseline, 1 and 6 months

Neuropsychological Assessment

Change Test (higher scores mean a better outcome)

Time frame: Baseline, 1 and 6 months

Changes in Functional Cognitive State

Global Deterioration Scale (values 1-7, higher scores mean a worse outcome)

Time frame: Baseline, 1 and 6 months

Secondary Outcomes

NeuroImaging

Magnetic Resonance Imaging (MRI) (white matter hyperintensities volume)

Time frame: baseline, 1 month, 6 months

Neurophysiology

Changes in Event-Related Potential (ERP) (oddball paradigm, auditory ERPs)

Time frame: Baseline, 1 month, 12 months

Electroencephalography recording

Changes in Electroencephalography (EEG), resting state

Time frame: Baseline, 1 month, 6 months

Data from ClinicalTrials.gov

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