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

Primary Purpose

Mild Cognitive Impairment, Dementia, Intermittent Claudication

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Leg ischemia
Sponsored by
Aristotle University Of Thessaloniki
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Mild Cognitive Impairment

Eligibility Criteria

65 Years - 95 Years (Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    No Intervention

    Experimental

    No Intervention

    Arm Label

    Group 90 individuals, baseline assessment before intervention

    Remote ischemic condition of the brain

    Late cognitive assessment

    Arm Description

    Baseline Cognitive status assessment

    Intermittent claudication induction on a daily basis for 1 month

    Late cognitive status assessment 6 months later

    Outcomes

    Primary Outcome Measures

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

    Secondary Outcome Measures

    NeuroImaging
    Magnetic Resonance Imaging (MRI) (white matter hyperintensities volume)
    Neurophysiology
    Changes in Event-Related Potential (ERP) (oddball paradigm, auditory ERPs)
    Electroencephalography recording
    Changes in Electroencephalography (EEG), resting state

    Full Information

    First Posted
    November 10, 2019
    Last Updated
    November 18, 2019
    Sponsor
    Aristotle University Of Thessaloniki
    Collaborators
    Greek Alzheimer's Association and Related Disorders
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04168021
    Brief Title
    Remote Ischemic Conditioning of the Human Brain in Dementia Patients
    Acronym
    RICBDE
    Official Title
    Remote Ischemic Conditioning of the Human Brain in Dementia Patients (RICBDE): Protocol for a Crossover Non-pharmaceutical Intervention Study
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    November 2019
    Overall Recruitment Status
    Unknown status
    Study Start Date
    January 1, 2020 (Anticipated)
    Primary Completion Date
    August 31, 2021 (Anticipated)
    Study Completion Date
    December 31, 2021 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Aristotle University Of Thessaloniki
    Collaborators
    Greek Alzheimer's Association and Related Disorders

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Mild Cognitive Impairment, Dementia, Intermittent Claudication

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Crossover Assignment
    Masking
    Care ProviderOutcomes Assessor
    Allocation
    Non-Randomized
    Enrollment
    90 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Group 90 individuals, baseline assessment before intervention
    Arm Type
    No Intervention
    Arm Description
    Baseline Cognitive status assessment
    Arm Title
    Remote ischemic condition of the brain
    Arm Type
    Experimental
    Arm Description
    Intermittent claudication induction on a daily basis for 1 month
    Arm Title
    Late cognitive assessment
    Arm Type
    No Intervention
    Arm Description
    Late cognitive status assessment 6 months later
    Intervention Type
    Behavioral
    Intervention Name(s)
    Leg ischemia
    Intervention Description
    potential neuroprotection of ischemia/reperfusion of a peripheral organ or tissue against cerebral I/R injury
    Primary Outcome Measure Information:
    Title
    Measurements to Assess General Cognitive Function
    Description
    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
    Title
    Neuropsychological Assessment
    Description
    Change Test (higher scores mean a better outcome)
    Time Frame
    Baseline, 1 and 6 months
    Title
    Changes in Functional Cognitive State
    Description
    Global Deterioration Scale (values 1-7, higher scores mean a worse outcome)
    Time Frame
    Baseline, 1 and 6 months
    Secondary Outcome Measure Information:
    Title
    NeuroImaging
    Description
    Magnetic Resonance Imaging (MRI) (white matter hyperintensities volume)
    Time Frame
    baseline, 1 month, 6 months
    Title
    Neurophysiology
    Description
    Changes in Event-Related Potential (ERP) (oddball paradigm, auditory ERPs)
    Time Frame
    Baseline, 1 month, 12 months
    Title
    Electroencephalography recording
    Description
    Changes in Electroencephalography (EEG), resting state
    Time Frame
    Baseline, 1 month, 6 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    65 Years
    Maximum Age & Unit of Time
    95 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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

    12. IPD Sharing Statement

    Plan to Share IPD
    Yes
    IPD Sharing 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.

    Learn more about this trial

    Remote Ischemic Conditioning of the Human Brain in Dementia Patients

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