Remote Ischemic Conditioning of the Human Brain in Dementia Patients

Not Applicable

• Conditions: Intermittent Claudication; Dementia; Mild Cognitive Impairment
• Interventions: Behavioral: Leg ischemia

• Registration Number: NCT04168021
• Lead Sponsor: Aristotle University Of Thessaloniki

Brief Summary

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

Detailed Description

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 Timeline

• Status Verified: 2019-11
• Study First Submitted: 2019-11-10
• Study First Submitted QC: 2019-11-18
• Last Update Submitted: 2019-11-18
• Study First Posted: 2019-11-19
• Last Update Posted: 2019-11-19
• Study Start: 2020-01-01
• Primary Completion: 2021-08-31
• Study Completion: 2021-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 90

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Remote ischemic condition of the brain	Leg ischemia	Intermittent claudication induction on a daily basis for 1 month

Primary Outcome Measures

Name	Time	Method
Measurements to Assess General Cognitive Function	Baseline, 1 and 6 months	Change in Mini Mental State Examination (minimum value 10 - maximum value 30, higher scores mean a better outcome)
Neuropsychological Assessment	Baseline, 1 and 6 months	Change Test (higher scores mean a better outcome)
Changes in Functional Cognitive State	Baseline, 1 and 6 months	Global Deterioration Scale (values 1-7, higher scores mean a worse outcome)

Secondary Outcome Measures

Name	Time	Method
NeuroImaging	baseline, 1 month, 6 months	Magnetic Resonance Imaging (MRI) (white matter hyperintensities volume)
Electroencephalography recording	Baseline, 1 month, 6 months	Changes in Electroencephalography (EEG), resting state
Neurophysiology	Baseline, 1 month, 12 months	Changes in Event-Related Potential (ERP) (oddball paradigm, auditory ERPs)