Dementia Clinical Trial
— RICBDEOfficial title:
Remote Ischemic Conditioning of the Human Brain in Dementia Patients (RICBDE): Protocol for a Crossover Non-pharmaceutical Intervention Study
Verified date | November 2019 |
Source | Aristotle University Of Thessaloniki |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The study investigates the incidence of remote ischemic conditioning in mild cognitive impairment and dementia patients
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 |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Aristotle University Of Thessaloniki | Greek Alzheimer's Association and Related Disorders |
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 |
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