Safety and Efficacy of Remote Ischemic Conditioning on Cerebral Amyloid Angiopathy. (RIC-CAA)

Last updated: January 12, 2022
Sponsor: Capital Medical University
Overall Status: Active - Recruiting

Phase

N/A

Condition

Amyloidosis

Alzheimer's Disease

Treatment

N/A

Clinical Study ID

NCT05207475
RIC-CAA
  • Ages 55-85
  • All Genders

Study Summary

Cerebral amyloid angiopathy (CAA) is a common form of cerebral small vessel disease, characterized by symptomatic intracerebral hemorrhage and cognitive impairment. However, no effective prevention and treatment strategies have been established. This study aims to evaluate the safety and efficacy of remote ischemic conditioning on patients with CAA.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Age≥55 and ≤85.
  2. The diagnosis of probable CAA and probable CAA with supporting pathology by the Bostoncriteria.
  3. Signed and dated informed consented is obtained.

Exclusion

Exclusion Criteria:

  1. Familial hereditary CAA or other hereditary small-vessel disorders.
  2. Previous intracranial hemorrhage caused by other reasons, such as tumor, cerebralcavernous angioma, ruptured aneurysm, arteriovenous malformation, venous sinusthrombosis and so on.
  3. A history of stroke within 3 months.
  4. The degree of intracranial or extracranial large artery stenosis >50%.
  5. Clinical diagnosis of probable AD by National Institute of Neurological andCommunicative Diseases and Stroke/Alzheimer's Disease and Related DisordersAssociation (NINCDS-ADRDA) criteria.
  6. 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.
  7. Inability to walk 6m unaided or other conditions that affected gait performance, suchas Parkinson.
  8. Illiteracy and patients with severe visual or hearing impairment.
  9. Contraindication to MRI scan, such as intracranial metal implants, cardiac pacemaker,severe claustrophobia, history of seizures and so on.
  10. Patients with missing or poor-quality MRI sequences at baseline and follow-up.
  11. Patients with a pre-existing neurological deficits (modified Ranks scale score >2) orpsychiatric disease that would confound the neurological or functional evaluations.
  12. Alcohol dependence and other psychoactive substance abuse
  13. Contraindication for remote ischemic conditioning: severe soft tissue injury, limbdeformities, fracture, atrial fibrillation or peripheral vascular disease in the upperlimbs.
  14. Life expectancy of less than 1 year due to co-morbid conditions.
  15. Severe, sustained hypertension (SBP > 180 mmHg or DBP > 110 mmHg).
  16. Severe renal or hepatic disease.
  17. Known pregnancy (or positive pregnancy test), or breast-feeding.
  18. Concurrent participation in another research protocol for investigation of anotherexperimental therapy.
  19. 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

CAA is a cerebrovascular disease caused by the deposition of β-amyloid in the walls of arteries, arterioles, and capillaries in the cerebral cortex and overlying leptomeninges. It is often associated with repeated lobar intracerebral hemorrhages, progressive cognitive decline, transient neurological symptoms and gait disturbances. No treatment is specific for symptomatic management of CAA up to date. Remote ischemic conditioning is a non-invasive strategy to protect the brain. The clinical trials have demonstrated that daily limb RIC seems to be potentially effective in patients with cerebral small-vessel disease in slowing cognition decline and reducing white matter hyperintensities. Thereby, investigators design this study to assess whether RIC has a beneficial effect on CAA.

Connect with a study center

  • Xuan Wu Hospital,Capital Medical University

    Beijing, Beijing 100069
    China

    Active - Recruiting

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