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Bilateral Upper Arm Compression Ischemic Preconditioning for Alzheimer’s Disease: A Randomized, Sham-Controlled, Double-Blind Exploratory Study

Bilateral Upper Arm Compression Ischemic Preconditioning for Alzheimer’s Disease: A Randomized, Sham-Controlled, Double-Blind Exploratory Study

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600127499
Enrollment
Unknown
Registered
2026-07-01
Start date
2026-07-01
Completion date
Unknown
Last updated
2026-07-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Alzheimer’s disease

Interventions

RIC intervention group:Bilateral upper arm wearing standard medical intermittent pneumatic compression cuffs, pressure higher than systolic blood pressure by 30-50 mmHg, maintained for 5 minutes, foll
Sham intervention control group:Wearing identical intermittent pneumatic compression cuffs, performing the same inflation-deflation cycles, but cuff pressure lower than patient's diastolic blood press

Sponsors

The First Affiliated Hospital of Xi'an Jiaotong University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
40 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Patients from the neurology outpatient clinic or inpatient ward of our hospital, aged 40–80 years, male or female; 2. Clinically diagnosed with mild-to-moderate Alzheimer’s disease (AD) according to the 2024 diagnostic criteria for AD dementia established by the National Institute on Aging and the Alzheimer’s Association (NIA-AA); 3. Having a stable caregiver who can accompany the patient to the hospital for remote ischemic conditioning (RIC) intervention 5 days per week during the study period; 4. Able to cooperate with clinical assessments including MMSE, ADAS-cog, NPI, ADL, and other relevant scales; 5. Medication requirements: - Patients diagnosed with mild AD must have been on a stable dose of donepezil (2.5–5 mg/day) for at least 3 months before enrollment; - Patients diagnosed with moderate AD must have been on a stable combination of donepezil (2.5–5 mg/day) and memantine (5–10 mg/day) for at least 3 months before enrollment; 6. Willing to participate in this study and sign the informed consent form.

Exclusion criteria

Exclusion criteria: 1. Presence of skin lesions, infection, lymphedema, severe pain, or severe peripheral arterial disease in the upper limbs that would preclude the use of a compression cuff; 2. Comorbid systemic diseases, such as a history of chronic kidney disease or creatinine clearance =160 mmHg or diastolic blood pressure >=100 mmHg), or a history of hypertensive crisis or hypertensive encephalopathy; 4. Presence of uncorrectable visual or hearing impairment that precludes completion of neuropsychological tests.

Design outcomes

Primary

MeasureTime frame
Change in the cognitive subscale score of the Alzheimer's Disease Assessment Scale (ADAS-cog);

Secondary

MeasureTime frame
To record adverse events occurring throughout the study period, particularly those related to the RIC procedure (such as limb numbness, pain, ecchymosis, etc.), in order to evaluate the safety and tol;To compare the between-group differences in the changes of MMSE, NPI, and ADL scores at baseline and at each follow-up time point (weeks 4, 12, 24, 36, and 48) between the two groups.;

Countries

China

Contacts

Public ContactZhao Beiyu

The First Affiliated Hospital of Xi'an Jiaotong University

402936605@qq.com+86 13228062065

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Jul 23, 2026