Daphnetin Capsule In the Treatment of VaScular COgnitive Impairment Without Dementia
NCT Number: NCT06507488
Acronym: DISCO
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Cerebrovascular Disorders
Interventions: DRUG: Daphnetin Capsule|DRUG: Placebo
Sponsor: First People's Hospital of Shenyang
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 206
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-08
Completion Date: 2026-04
Locations: First People's Hospital of Shenyang, Shenyang, Liaoning, 110041, China

Summary:
The purpose of this clinical trial is to understand and evaluate the clinical efficacy and safety of Daphnetin Capsule in patients with vascular cognitive impairment. Changes in the Vascular Dementia Assessment Scale-cog(VADAS-cog) at 6 months were evaluated. Although Daphnetin has a dual neurovascular protective effect, however, there is still a lack of relevant high-quality studies on its role in patients with vascular cognitive impairment, especially in patients with vascular cognitive impairment in non-dementia (VCI-ND), whether it has a role in improving cognitive status needs to be urgently explored in high-quality clinical studies. Researchers are comparing Daphnetin to placebo (a drug-free analog) to see if Daphnetin is effective in treating vascular cognitive impairment. Participants will take either Daphnetin or placebo daily for six months, with follow-up visits every three months and completion of a case report form.

Primary Outcome Measures: Changes in Vascular Dementia Assessment Scale-cognitive subscale (VADAS-cog), Vascular Dementia Assessment Scale-cognitive subscale（VADAS-cog） is a revision of the Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-cog) to be a better measure in vascular conditions，The lowest score is 0, with higher scores representing higher levels of cognitive dysfunction and poorer status of the patient., 6 months
Secondary Outcome Measures: Incidence of combined endpoints: including new stroke (ischemic Trial of ORG 10172 in Acute Stroke Treatment typing [TOAST typing] or hemorrhagic)/transient ischemic attack, myocardial infarction, new-onset dementia, death, For categorical indicators, the stratified Cochran- Mantel-Haenszel (CMH) test will be used for analysis., 6 months|Incidence of each individual event of the combined endpoint, For categorical indicators, the stratified Cochran- Mantel-Haenszel (CMH) test will be used for analysis., 6 months|Clinician Interview-Based studies Impression of Change scale-plus version(CIBIC-Plus) of change, Consists of three parts The clinician's impression of change is an assessment of change from baseline, not an assessment of severity. The clinician may refer to his/her own baseline information compiled in Part I when making the assessment of change. The clinician's assessment of impression of change should then be replicated in the main study case report form.The score of CIBIC-plus ranges from 1 to 7, and the score of 1-3 indicates improvement, 4 means no changed, and 5-7 indicates worse., 6 months|Change in the Brief Mental State Evaluation Scale (MMSE), Each correct item is scored as 1 point, and errors are scored as 0 points. The total score ranges from 0 to 30, and the cut-off value for normal and abnormal is related to the level of education; ≤17 points for the illiterate (no education) group, ≤20 points for the elementary school (≤6 years of education) group, and ≤24 points for the secondary school or above (\>6 years of education) group. Cognitive deficits are considered to be below the cut-off value and normal above it., 6 months|Change in the Montreal Cognitive Assessment Scale (MoCA), The MoCA scale is a 30-point scale, with ≥26 normal, 18-26 mild cognitive impairment (MCI), 10-17 moderate, and less than 10 severe.Patients with MCI scored approximately 22 (19-25) points, and patients with AD scored between 11-21 points., 6 months|Changes in the Symbol Digit Transformation Test (SDMT), Completion of the SDMT scale within 90 seconds, with a total score of 0-110; the lower the score, the more severe the degree of cognitive impairment, 6 months|Change in Clinical Dementia Rating Scale (CDR), The total score ranges from 0 to 18,The higher the score, the more demented the patient is, the worse the state is., 6 months|Change in Neuropsychiatric Questionnaire (NPI-Q), Presence of symptoms (1-2): 1=present 2=absent. Frequency (1-4 points): 1=occasional, less than weekly; 2=frequent, about weekly; 3=several times a week but less than daily; 4=very frequent, once or more at a time or continuously.

Severity (on a scale of 1 to 3): 1=mild, perceptible but not obvious; 2=moderate, obvious but not very prominent; 3=severe, very prominent changes.

The degree of distress caused by the symptom to the caregiver (0-5 points): 0 = no distress; 1 = very mild distress, caregiver does not need to take steps to cope; 2 = mild distress, caregiver copes easily; 3 = moderate distress, caregiver struggles to cope; 4 = severe, caregiver is barely able to cope; 5 = extreme distress, caregiver is unable to cope. The higher the score the more severe, 6 months|Changes in the Activities of Daily Living Scale (ADL), 1 = can do it all by myself; 2 = can still do it with some difficulty; 3 = need help 4 = cannot do it at all. When the patient never does it but is able to do it, it is rated as 1, never does it but has difficulty doing it but does not need help, 2, never does it but needs help, 3, never does it and is unable to do it, 4. The range of scores is from 20 to 80, and a score of \>23 is considered to be cognitively impaired., 6 months|Changes in motor function (TUG, time to walk three meters), Change in motor score (TUG, time to walk three meters) at 6 months relative to baseline, 6 months|EuroQol Five Dimensions Questionnaire (EQ-5D), The EuroQol Five Dimensions Questionnaire (EQ-5D) health description system consists of five dimensions: mobility (MO), self-care (SC), ability to perform activities of daily living (UA), pain or discomfort (PD), and anxiety or depression (AD), each of which can be reported separately as "no problem, moderate problem, or severe problem".Self-rated health on a scale of 0 to 100, the higher the score the better your health is considered to be., 6 months