Last updated: January 12, 2022
Sponsor: Capital Medical University
Overall Status: Active - Recruiting
Phase
N/A
Condition
Amyloidosis
Alzheimer's Disease
Treatment
N/AClinical Study ID
NCT05207475
RIC-CAA
Ages 55-85 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Age≥55 and ≤85.
- The diagnosis of probable CAA and probable CAA with supporting pathology by the Bostoncriteria.
- Signed and dated informed consented is obtained.
Exclusion
Exclusion Criteria:
- Familial hereditary CAA or other hereditary small-vessel disorders.
- Previous intracranial hemorrhage caused by other reasons, such as tumor, cerebralcavernous angioma, ruptured aneurysm, arteriovenous malformation, venous sinusthrombosis and so on.
- A history of stroke within 3 months.
- The degree of intracranial or extracranial large artery stenosis >50%.
- Clinical diagnosis of probable AD by National Institute of Neurological andCommunicative Diseases and Stroke/Alzheimer's Disease and Related DisordersAssociation (NINCDS-ADRDA) criteria.
- Significant cognitive impairment (defined as Mini-mental State Examination (MMSE)score of ≥20 (primary school) or ≥24 (junior school or above) or other diseasesresulting from severe cognitive impairment.
- Inability to walk 6m unaided or other conditions that affected gait performance, suchas Parkinson.
- Illiteracy and patients with severe visual or hearing impairment.
- Contraindication to MRI scan, such as intracranial metal implants, cardiac pacemaker,severe claustrophobia, history of seizures and so on.
- Patients with missing or poor-quality MRI sequences at baseline and follow-up.
- Patients with a pre-existing neurological deficits (modified Ranks scale score >2) orpsychiatric disease that would confound the neurological or functional evaluations.
- Alcohol dependence and other psychoactive substance abuse
- Contraindication for remote ischemic conditioning: severe soft tissue injury, limbdeformities, fracture, atrial fibrillation or peripheral vascular disease in the upperlimbs.
- Life expectancy of less than 1 year due to co-morbid conditions.
- Severe, sustained hypertension (SBP > 180 mmHg or DBP > 110 mmHg).
- Severe renal or hepatic disease.
- Known pregnancy (or positive pregnancy test), or breast-feeding.
- Concurrent participation in another research protocol for investigation of anotherexperimental therapy.
- Any condition which, in the judgment of the investigator, might increase the risk tothe patient.
Study Design
Total Participants: 30
Study Start date:
January 20, 2022
Estimated Completion Date:
January 20, 2022
Study Description
Connect with a study center
Xuan Wu Hospital,Capital Medical University
Beijing, Beijing 100069
ChinaActive - Recruiting
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