Remote Ischemic Conditioning of the Human Brain in Dementia Patients (RICBDE): Protocol for a Crossover Non-pharmaceutical Intervention Study
Trial Snapshot
- Phase
- Not Applicable
- Enrollment
- 90
- Primary Endpoint
- Measurements to Assess General Cognitive Function
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Treatment
- Masking
- Double (Care Provider, Outcomes Assessor)
Eligibility Criteria
- Ages
- 65 Years to 95 Years (Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Group 90 individuals, baseline assessment before intervention
Baseline Cognitive status assessment
Remote ischemic condition of the brain
Intermittent claudication induction on a daily basis for 1 month
Intervention: Leg ischemia (Behavioral)
Late cognitive assessment
Late cognitive status assessment 6 months later
Outcomes
Primary Outcomes
Measurements to Assess General Cognitive Function
Time Frame: 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
Time Frame: Baseline, 1 and 6 months
Change Test (higher scores mean a better outcome)
Changes in Functional Cognitive State
Time Frame: Baseline, 1 and 6 months
Global Deterioration Scale (values 1-7, higher scores mean a worse outcome)
Secondary Outcomes
- NeuroImaging(baseline, 1 month, 6 months)
- Electroencephalography recording(Baseline, 1 month, 6 months)
- Neurophysiology(Baseline, 1 month, 12 months)
Investigators
Magda Tsolaki
Professor
Aristotle University Of Thessaloniki