Remote Ischemic Conditioning of the Human Brain in Dementia Patients

NCT ID: NCT04168021

Last Updated: 2019-11-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-01-01

Study Completion Date

2021-12-31

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.

Conditions

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Mild Cognitive Impairment Dementia Intermittent Claudication

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Caregivers Outcome Assessors

Study Groups

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Group 90 individuals, baseline assessment before intervention

Baseline Cognitive status assessment

Group Type NO_INTERVENTION

No interventions assigned to this group

Remote ischemic condition of the brain

Intermittent claudication induction on a daily basis for 1 month

Group Type EXPERIMENTAL

Leg ischemia

Intervention Type BEHAVIORAL

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

Late cognitive assessment

Late cognitive status assessment 6 months later

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Leg ischemia

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

Intervention Type BEHAVIORAL

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
Minimum Eligible Age

65 Years

Maximum Eligible Age

95 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Greek Alzheimer's Association and Related Disorders

OTHER

Sponsor Role collaborator

Aristotle University Of Thessaloniki

OTHER

Sponsor Role lead

Responsible Party

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Magda Tsolaki

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Other Identifiers

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BrainIRC

Identifier Type: -

Identifier Source: org_study_id

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