Remote Ischemic Conditioning of the Human Brain in Dementia Patients (RICBDE)

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

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

Study Overview

• Status: Unknown
• Conditions: Dementia; Intermittent Claudication; Mild Cognitive Impairment
• Intervention / Treatment: Behavioral: Leg ischemia

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 Type: Interventional
• Enrollment (Anticipated): 90
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years to 95 years (Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Aristotle University Of Thessaloniki
• Collaborators: Greek Alzheimer's Association and Related Disorders

Study record dates

Study Major Dates

• Study Start (Anticipated): January 1, 2020
• Primary Completion (Anticipated): August 31, 2021
• Study Completion (Anticipated): December 31, 2021

Study Registration Dates

• First Submitted: November 10, 2019
• First Submitted That Met QC Criteria: November 18, 2019
• First Posted (Actual): November 19, 2019

Study Record Updates

• Last Update Posted (Actual): November 19, 2019
• Last Update Submitted That Met QC Criteria: November 18, 2019
• Last Verified: November 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Cardiovascular Diseases; Vascular Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Neurocognitive Disorders; Cognition Disorders; Dementia; Cognitive Dysfunction; Intermittent Claudication
• Other Study ID Numbers: BrainIRC

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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.
• IPD Sharing Time Frame: Data will be available (start and end dates) immediately following publication, No end date
• IPD Sharing Access Criteria: To gain access, data requestors will need to sign a data access agreement.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No