Remote Ischemic Conditioning of the Human Brain in Dementia Patients

Dementia Clinical Trial

— RICBDE  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04168021
• Other study ID #: BrainIRC
• Status: Not yet recruiting
• Phase: N/A
• Start date: January 1, 2020
• Est. completion date: December 31, 2021

Study information

• Verified date: November 2019
• Source: Aristotle University Of Thessaloniki
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 90
• Est. completion date: December 31, 2021
• Est. primary completion date: August 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years to 95 Years

Eligibility

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

Related Conditions & MeSH terms

• Cognitive Dysfunction
• Dementia
• Intermittent Claudication
• Mild Cognitive Impairment

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Aristotle University Of Thessaloniki	Greek Alzheimer's Association and Related Disorders

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Neuropsychological Assessment	Change Test (higher scores mean a better outcome)	Baseline, 1 and 6 months
Primary	Changes in Functional Cognitive State	Global Deterioration Scale (values 1-7, higher scores mean a worse outcome)	Baseline, 1 and 6 months
Secondary	NeuroImaging	Magnetic Resonance Imaging (MRI) (white matter hyperintensities volume)	baseline, 1 month, 6 months
Secondary	Neurophysiology	Changes in Event-Related Potential (ERP) (oddball paradigm, auditory ERPs)	Baseline, 1 month, 12 months
Secondary	Electroencephalography recording	Changes in Electroencephalography (EEG), resting state	Baseline, 1 month, 6 months