Clinical trial NCT03022149: Remote Ischemic Preconditioning for Subcortical Vascular Dementia
Official title: Remote Ischemic Preconditioning for Subcortical Vascular Dementia
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Subcortical Vascular Dementia
Lead sponsor: Tianjin Medical University General Hospital
Sponsor class: OTHER
First posted: 2017-01-16
Enrollment: 52
Sex: ALL
Minimum age (years): 50
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine whether the remote ischemic preconditioning are effective in the treatment of mild to moderate vascular dementia.

Detailed description: In this randomized, double-blind, placebo-controlled trial, the investigators enrolled 52 participants aged 50-80 years. The participants had a diagnosis of subcortical vascular dementia at the neurology department of Tianjin medical university general hospital. Inclusion criteria included a clinical dementia rating 1-2; a mini-mental state examination score 15-26; and brain magnetic resonance imaging consistent with subcortical ischemic small vessel disease. All participants received standard medical management.Participants in the remote ischemic preconditioning group underwent 5 brief cycles consisting of bilateral upper limb ischemia followed by reperfusion. The remote ischemic precondition procedure was performed once daily over 180 consecutive days. Cognitive impairment assessment scale ( Hopkins Verbal Learning Test,HVLT;Symbol digital modalities tes,SDMT;judgement line orientation, JLO;trail making test A and B,TMT-A/B;chinese word fluency test;Activity of Daily Living Scale,ADL;Neuropsychiatric Inventory,NPI), serological inflammatory markers:hypersensitive C-reactive protein（hs-CRP）、plasma tumor necrosis factor-α(TNF-α)、interleukin-1β(IL-1β)、interleukin-6 (IL-6)、α1-antichymotrypsin),and MRI diffusion tensor imaging, DTI were compared with the untreated control group.

Eligibility criteria: Inclusion Criteria:

1. Clinical diagnosis of vascular dementia
2. In three months without cerebral infarction
3. MMSE 15 to 26 points;CDR 1-2 points;MoCA \< 26 points
4. MRI showed subcortical ischemic cerebrovascular disease.

Exclusion Criteria:

1. AD 、 FTD, DLB and other causes of dementia.
2. Cortical/subcortical infarction
3. Cortex watershed infarction
4. Cerebral hemorrhage
5. Hydrocephalus
6. Other special causes of white matter lesions such as multiple sclerosis, sarcoidosis, radiation encephalopathy, etc.
7. Cannot complete aphasia neuropsychological assessment.
8. Genetic or inflammatory small vascular disease.
9. Serious cardiovascular, lung, liver, kidney, endocrine, such as infection disease.
10. Alcohol poisoning;
11. Cancer
12. Hypothyroidism
13. Schizophrenia;Hamilton depression rating scale \> 17 points.
14. Can not complete MRI.

Primary outcomes:
measure: Cognitive impairment assessment scale-HVLT
timeFrame: At the first day/sixth month after randomization
measure: Cognitive impairment assessment scale-SDMT
timeFrame: At the first day/sixth month after randomization
measure: Cognitive impairment assessment scale-JLO
timeFrame: At the first day/sixth month after randomization
measure: Cognitive impairment assessment scale-ADL
timeFrame: At the first day/sixth month after randomization
measure: Cognitive impairment assessment scale-TMT
timeFrame: At the first day/sixth month after randomization
measure: Cognitive impairment assessment scale-NPI
timeFrame: At the first day/sixth month after randomization
measure: Cognitive impairment assessment scale-Chinese auditory learning test
timeFrame: At the first day/sixth month after randomization
Secondary outcomes:
measure: Serological inflammatory markers-hs-CRP
timeFrame: At the fist day/sixth month after randomization
measure: Serological inflammatory markers-TNF-a
timeFrame: At the fist day/sixth month after randomization
measure: Serological inflammatory markers-IL - 1b
timeFrame: At the fist day/sixth month after randomization
measure: Serological inflammatory markers-IL - 6
timeFrame: At the fist day/sixth month after randomization
measure: Serological inflammatory markers-ACT
timeFrame: At the fist day/sixth month after randomization
measure: Imaging markers-DTI
timeFrame: At the fist day/sixth month after randomization
measure: Imaging markers-Routine MRI
timeFrame: At the fist day/sixth month after randomization
Other outcomes:
measure: Laboratory examination of the urine routine
timeFrame: At the first month/third month after randomization
measure: Laboratory examination of the blood routine
timeFrame: At the first month/third month after randomization
measure: Laboratory examination of the blood coagulation function
timeFrame: At the first month/third month after randomization
measure: Laboratory examination of the liver function
timeFrame: At the first month/third month after randomization
measure: Laboratory examination of the kidney function
timeFrame: At the first month/third month after randomization
Locations:
city: Tianjin
country: China
facility: Tianjin Medical University General Hospital
state: Tianjin
Study officials:
affiliation: Tianjin Medical University General Hospital
name: Junwei Hao, PHD, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Liao Z, Bu Y, Li M, Han R, Zhang N, Hao J, Jiang W. Remote ischemic conditioning improves cognition in patients with subcortical ischemic vascular dementia. BMC Neurol. 2019 Aug 23;19(1):206. doi: 10.1186/s12883-019-1435-y.