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DISCO
RecruitingPhase NADaphnetin Capsule In the Treatment of VaScular COgnitive Impairment Without Dementia
Daphnetin Capsule In the Treatment of VaScular COgnitive Impairment Without Dementia - A Randomized, Double-blind, Placebo-controlled Study
Lead sponsor
Asset
Daphnetin
Listed sites
1
Recruiting sites
1
Enrollment
206
estimated
Study population
Vascular cognitive impairment / dementia
Key I/E criterion
•MoCA 18-26
Primary endpoint
•ADAS-Cog
Footprint
Where this trial recruits
Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.
Identifiers
Registered as
Timeline
Milestones
Assets
Drug assets
Study populations
Who this study enrolls
Eligibility
Who can enroll
Inclusion criteria
1. Be 50-80 years of age (both ends included)
2. Have a complaint of cognitive impairment involving memory and/or other cognitive domains that has persisted for at least 3 months
3. Have a cognitive level that is neither normal nor demented according to Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition, Criteria ( DSM-V criteria), a Montreal Cognitive Assessment (MoCA scale) score <26 and ≥18, and a Clinical Dementia Rating (CDR) scale score of ≥0.5 in at least one domain and an overall CDR score ≤1
4. Have a cognitive level that is neither normal nor demented according to DSM-V criteria, a MoCA scale score <26 and ≥18, and a CDR scale score of ≥0.5 in at least one domain and an overall CDR score ≤1
5. Voluntarily participate in this study and sign an informed consent form
Exclusion criteria
1. Previously diagnosed dementia; vascular cognitive impairment not associated with a condition other than dementia that may affect cognition
2. Acute stroke event within 6 months
3. Previously diagnosed hereditary or inflammatory small vessel disease
4. Presence of congenital mental retardation and severe neurological or psychiatric disorders
5. Illiteracy or severe visual or hearing impairment, severe aphasia, and other factors that may preclude cooperation with neuropsychological evaluation
6. Associated depression (Hamilton Depression Scale score ≥ 17), or other unrelated serious mental illness (schizophrenia, bipolar disorder, or delirium)
7. Combined severe cardiac, pulmonary, and renal insufficiency (creatinine > 2.0 mg/dl or 177 μ mol/L), and severe hepatic impairment (aminotransferases more than 3 times normal)
8. Alcoholism, drug addiction, or ongoing use of medications that affect cognitive assessment, such as tranquilizers, sleeping pills, puberty pills, and cholinergics
9. Malignant tumors that have been clearly diagnosed, vital organ failure
10. Those with bleeding tendency after surgery
11. Pregnant and lactating women are prohibited
12. Severe hypertension (Systolic Blood Pressure(SBP)≥160mmHg and/or Diastolic Blood Pressure(DBP)≥110mmHg) is prohibited
13. Previous allergy or intolerance to the ingredients of Reserpine
14. The subject does not have a stable and reliable caregiver or the caregiver is unable to assist the subject in participating in the study
15. Patients who have participated in other interventional clinical studies within the last 3 months or are currently participating in other interventional clinical studies.
Endpoints (12)
What's being measured
Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.
Coverage by outcome category
Global cognition
4 endpointsChanges in Vascular Dementia Assessment Scale-cognitive subscale (VADAS-cog)
Time frame:6 months
ADAS-Cog
categorical status, descriptive
Change in the Brief Mental State Evaluation Scale (MMSE)
Time frame:6 months
Mini-Mental State Examination (MMSE)
change from baseline, improvement
Change in the Montreal Cognitive Assessment Scale (MoCA)
Time frame:6 months
Montreal Cognitive Assessment (MoCA)
change from baseline, improvement
Change in Clinical Dementia Rating Scale (CDR)
Time frame:6 months
change from baseline, improvement
Function / daily living
2 endpointsChanges in the Activities of Daily Living Scale (ADL)
Time frame:6 months
descriptive
EuroQol Five Dimensions Questionnaire (EQ-5D)
Time frame:6 months
descriptive
Behavior / neuropsychiatric
1 endpointChange in Neuropsychiatric Questionnaire (NPI-Q)
Time frame:6 months
Neuropsychiatric Inventory (NPI)
change from baseline, improvement
Other clinical outcomes
2 endpointsIncidence 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
Time frame:6 months
event count, event
Clinician Interview-Based studies Impression of Change scale-plus version(CIBIC-Plus) of change
Time frame:6 months
change from baseline, improvement
Other (unclassified)
3 endpointsIncidence of each individual event of the combined endpoint
Time frame:6 months
event count, event
Changes in the Symbol Digit Transformation Test (SDMT)
Time frame:6 months
descriptive
Changes in motor function (TUG, time to walk three meters)
Time frame:6 months
change from baseline, improvement
Publications (24)
Bibliography
Records linked to this trial through ClinicalTrials.gov references, PubMed NCT search, and curated study seeds. 'Canonical' marks design/result papers; others are registry references or candidates.
Registry references + supporting bibliography
- PMID36982853via BACKGROUND
- PMID30260007via BACKGROUND
- PMID24747094via BACKGROUND
- PMID33860917via BACKGROUND
- PMID33902056via BACKGROUND
- PMID25475248via BACKGROUND
- PMID23776645via BACKGROUND
- PMID28515342via BACKGROUND
- PMID31950453via BACKGROUND
- PMID22961470via BACKGROUND
- PMID36249766via BACKGROUND
- PMID22156700via BACKGROUND
- PMID30859119via BACKGROUND
- PMID24343531via BACKGROUND
- PMID32054507via BACKGROUND
- PMID31050033via BACKGROUND
- PMID26036939via BACKGROUND
- PMID34182245via BACKGROUND
- PMID17975326via BACKGROUND
- PMID23803634via BACKGROUND
- PMID25225718via BACKGROUND
- PMID35513128via BACKGROUND
- PMID35969390via BACKGROUND
- PMID29273521via BACKGROUND
Provenance
Sources
Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 21, 2026 snapshot.