BridgeMD
New treatment option for Cerebrovascular Disorders
Official title Daphnetin Capsule In the Treatment of VaScular COgnitive Impairment Without Dementia
ClinicalTrials.gov ID: NCT06507488
What this study is testing
What is Daphnetin Capsule?
Daphnetin Capsule is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for cerebrovascular disorders.
Also referred to as 7,8-dihydroxycoumarin.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 50 to 80
You may be able to join 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...
- 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...
- Voluntarily participate in this study and sign an informed consent form.
You likely can't join 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)
See the full eligibility criteria
- 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)...
- 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.
- 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 treatment clinical studies within the last 3 months or are currently participating in other treatment clinical studies.
The study team makes the final eligibility decision.
Where it's taking place
- Shenyang, Liaoning, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 50 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Shenyang, Liaoning, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.