Chronic Remote Ischemic Conditioning in Vascular Cognitive Impairment: A Dose Escalation Study

Last updated: December 12, 2023
Sponsor: Augusta University
Overall Status: Active - Recruiting

Phase

N/A

Condition

Memory Loss

Dementia

Mild Cognitive Impairment

Treatment

remote ischemic conditioning

Clinical Study ID

NCT06179797
1513705-3
  • Ages > 56
  • All Genders

Study Summary

To evaluate the dose-response of relevant blood biomarkers to remote ischemic conditioning in patients with age-related cerebral white matter hyperintensities on MRI, in preparation for a subsequent larger efficacy trial.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Age ≥55 years
  2. Head MRI in the past 6 months showing no more than moderate age related cerebral whitematter changes (Fazekas score 0-2).
  3. Able to walk without assistance & independently perform basic activities of dailyliving.
  4. Able to understand this study and agree for a valid consent.

Exclusion

Exclusion Criteria: Prior non-lacunar (cortical) stroke. 2. Unable to cooperate with the use of theconditioning device. 3. Confounding illness that might interfere with the interpretation ofresults (such as active malignancy or multiple sclerosis). 4. Contraindication to transient arm ischemia in either arm (such as symptomatic peripheralartery disease).

Study Design

Total Participants: 40
Treatment Group(s): 1
Primary Treatment: remote ischemic conditioning
Phase:
Study Start date:
August 15, 2020
Estimated Completion Date:
December 15, 2023

Study Description

Objective: The objective of this early phase study is to evaluate the dose-response of relevant blood biomarkers to remote ischemic conditioning in preparation for a subsequent larger efficacy trial. In addition, we will evaluate the tolerability and adherence to the treatment protocol.

Aim: We aim to measure blood biomarkers in response to daily remote ischemic conditioning (RIC) using a dose escalation study design in 40 patients with age-related cerebral white matter hyperintensities on MRI.

Hypothesis: We hypothesize that there will be a significant change in the biomarker levels in a dose dependent fashion.

Connect with a study center

  • Wellstar MCG Health

    Augusta, Georgia 30912
    United States

    Active - Recruiting

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