Dongzhimen Hospital, Beijing University of Chinese Medicine, Beijing, 100700
Beijing, Beijing Municipality, China
Location status: Recruiting
Location contact
Beida Ren, PhD
CONTACT
Yupeng Wei
CONTACT
NCT Number: NCT07342075
The incidence of cerebral small vessel disease (CSVD) increases with age, affecting approximately 5% of individuals over 50 years old and nearly all individuals over 90 years old. CSVD is also the most important vascular factor contributing to cognitive decline, with 45% of dementia patients attributed to CSVD. Existing interventions are similar to secondary prevention strategies for cardiovascular and cerebrovascular diseases, and no specific therapies are currently available.
CSVD-related cognitive impairment (CSVDCI) predominantly involves attention, processing speed, and executive functions, with relatively preserved memory function, and may be accompanied by non-cognitive clinical manifestations such as gait disturbances, emotional and behavioral disorders, and bladder dysfunction. Although CSVDCI can be classified under vascular cognitive impairment (VCI), there are certain differences in its clinical manifestations.
In summary, it is necessary to develop more targeted treatments for CSVD. We attempt to establish a "symptom-tongue coating-gut microbiota-imaging" system to provide data support for the subsequent exploration of CSVD treatments based on traditional Chinese medicine (TCM) syndrome differentiation and treatment.
Interested in participating?
Request Info50 year and older
All sexes
Observational
Beijing, Beijing Municipality, China
Location status: Recruiting
Beida Ren, PhD
CONTACT
Yupeng Wei
CONTACT
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: 6 months
Change from baseline in Montreal Cognitive Assessment (MoCA). Score range is 0-30. Higher score means good cognition.
Time frame: 6 months
Change from baseline in Mini-Mental State Examination (MMSE). Score range is 0-30. Higher score means good cognition.
Time frame: 6 months
Measure changes in whole-brain fiber connectivity on brain MRI diffusion tensor imaging (DTI).
Time frame: 6 months
Change from baseline in trail making test (TMT).TMT contains TMT-A and TMT-B. Both are related to age and education. The longer the duration of both tests, the poorer the ability to concentrate, process and perform.
Time frame: 6 months
Change from baseline in Tinetti Performance Oriented Mobility Assessment (POMA). Score range is 0-28. Lower score means higher risk of falling.
Time frame: 6 months
Change from baseline in instrumental activities of daily living (IADL). Score range is 0-24. Higher score means better daily living.
Time frame: 6 months
Change from baseline in Modified Rankin Scale (mRS).Score range is 0-6. Higher score means greater disability.
Time frame: 6 months
Change from baseline in the symptom. The study plans to analyze whether there are statistically significant differences in the incidence of major symptoms before and after treatment. Patient-reported outcomes (PROs) will be used to record the degree of change in patients' symptoms from baseline (expressed as a percentage, with >100% indicating symptom worsening and <100% indicating symptom relief). Meanwhile, baseline and 6-month tongue coating photos will be preserved.
Time frame: 6 months
Change from baseline in gut microbiota. Metagenomic sequencing technology will be applied to the analysis.
Time frame: 6 months
New vascular events include ischemic stroke, TIA, cerebral hemorrhage, MI, pulmonary embolism, thrombosis, peripheral arterial occlusion
Time frame: 6 months
Numbers in all-cause hospitalization
Contact information is provided by the study sponsor or research team.
Dongzhimen Hospital, Beijing
Other
Real-world Patient Registry Study of Cerebral Small Vessel Disease
Acronym: DZM-CSVD-R
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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