Dementia, Intermittent Claudication, Mild Cognitive Impairment
Conditions
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.
Interventions
BEHAVIORALLeg ischemia
potential neuroprotection of ischemia/reperfusion of a peripheral organ or tissue against cerebral I/R injury
Sponsors
Greek Alzheimer's Association and Related Disorders
Aristotle University Of Thessaloniki
Study design
Allocation
NON_RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
65 Years to 95 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Measurements to Assess General Cognitive Function | 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 | Baseline, 1 and 6 months | Change Test (higher scores mean a better outcome) |
| Changes in Functional Cognitive State | Baseline, 1 and 6 months | Global Deterioration Scale (values 1-7, higher scores mean a worse outcome) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| NeuroImaging | baseline, 1 month, 6 months | Magnetic Resonance Imaging (MRI) (white matter hyperintensities volume) |
| Neurophysiology | Baseline, 1 month, 12 months | Changes in Event-Related Potential (ERP) (oddball paradigm, auditory ERPs) |
| Electroencephalography recording | Baseline, 1 month, 6 months | Changes in Electroencephalography (EEG), resting state |
Outcome results
None listed