Skip to main content
Delfa

← Trials/Trial dossier/NCT06507488

DISCO

RecruitingPhase NA

Daphnetin 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

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

NCT IDNCT06507488
Org study IDRXSJNJLXD-2024-SYSY

Timeline

Milestones

Study first posted2024-07-18actual
Study start2025-07-07actual
Primary completion2025-07-07actual
Last update posted2025-08-28actual
Study completion2026-04-30estimated

Assets

Drug assets

Study populations

Who this study enrolls

Vascular cognitive impairment / dementia

Eligibility

Who can enroll

Minimum age50 Years
Maximum age80 Years
SexAll
Healthy volunteersNot accepted

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
Other (unclassified)
3
Function / daily living
2
Other clinical outcomes
2
Behavior / neuropsychiatric
1

Global cognition

4 endpoints
Primary/protocol endpoint

Changes in Vascular Dementia Assessment Scale-cognitive subscale (VADAS-cog)

Time frame:6 months

ADAS-Cog

categorical status, descriptive

Secondary/protocol endpoint

Change in the Brief Mental State Evaluation Scale (MMSE)

Time frame:6 months

Mini-Mental State Examination (MMSE)

change from baseline, improvement

Secondary/protocol endpoint

Change in the Montreal Cognitive Assessment Scale (MoCA)

Time frame:6 months

Montreal Cognitive Assessment (MoCA)

change from baseline, improvement

Secondary/protocol endpoint

Change in Clinical Dementia Rating Scale (CDR)

Time frame:6 months

change from baseline, improvement

Function / daily living

2 endpoints
Secondary/protocol endpoint

Changes in the Activities of Daily Living Scale (ADL)

Time frame:6 months

descriptive

Secondary/protocol endpoint

EuroQol Five Dimensions Questionnaire (EQ-5D)

Time frame:6 months

descriptive

Behavior / neuropsychiatric

1 endpoint
Secondary/protocol endpoint

Change in Neuropsychiatric Questionnaire (NPI-Q)

Time frame:6 months

Neuropsychiatric Inventory (NPI)

change from baseline, improvement

Other clinical outcomes

2 endpoints
Secondary/protocol endpoint

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

Time frame:6 months

event count, event

Secondary/protocol endpoint

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 endpoints
Secondary/protocol endpoint/low confidence

Incidence of each individual event of the combined endpoint

Time frame:6 months

event count, event

Secondary/protocol endpoint/low confidence

Changes in the Symbol Digit Transformation Test (SDMT)

Time frame:6 months

descriptive

Secondary/protocol endpoint/low confidence

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

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 21, 2026
Endpoint classificationDelfa ADRD endpoint taxonomy
Results tableno registry results posted yet

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.