NCT06507488 · RECRUITING
Daphnetin Capsule In the Treatment of VaScular COgnitive Impairment Without Dementia
This trial is testing whether Daphnetin, a plant-derived compound, can improve thinking and memory in people who have mild cognitive problems caused by blood vessel disease in the brain — but who have not yet developed full dementia. Participants take either Daphnetin capsules or a placebo daily for six months. It is a Phase NA trial, meaning it is likely an efficacy study but outside the standard Phase 1-3 framework, and the intervention is not yet proven or approved for this use.
You may qualify if
- Be 50-80 years of age (both ends included)
- Have a complaint of cognitive impairment involving memory and/or other cognitive domains that has persisted for at least 3 months
- 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
- 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
- Voluntarily participate in this study and sign an informed consent form.
You're excluded if
- Previously diagnosed dementia; vascular cognitive impairment not associated with a condition other than dementia that may affect cognition
- Acute stroke event within 6 months
- Previously diagnosed hereditary or inflammatory small vessel disease
- Presence of congenital mental retardation and severe neurological or psychiatric disorders
- Illiteracy or severe visual or hearing impairment, severe aphasia, and other factors that may preclude cooperation with neuropsychological evaluation
- Associated depression (Hamilton Depression Scale score ≥ 17), or other unrelated serious mental illness (schizophrenia, bipolar disorder, or delirium)
- 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)
- Alcoholism, drug addiction, or ongoing use of medications that affect cognitive assessment, such as tranquilizers, sleeping pills, puberty pills, and cholinergics
- Malignant tumors that have been clearly diagnosed, vital organ failure
- Those with bleeding tendency after surgery
- Pregnant and lactating women are prohibited
- Severe hypertension (Systolic Blood Pressure(SBP)≥160mmHg and/or Diastolic Blood Pressure(DBP)≥110mmHg) is prohibited
- Previous allergy or intolerance to the ingredients of Reserpine
- The subject does not have a stable and reliable caregiver or the caregiver is unable to assist the subject in participating in the study
- Patients who have participated in other interventional clinical studies within the last 3 months or are currently participating in other interventional clinical studies.
The sponsor's own eligibility wording, lightly reformatted. The study team makes the final eligibility decision — worth discussing with your doctor.
Eligibility criteria as of 2025-08-28