Daphnetin Capsule In the Treatment of VaScular COgnitive Impairment Without Dementia

Launched by FIRST PEOPLE'S HOSPITAL OF SHENYANG · Jul 12, 2024

Keywords

ClinConnect Summary

This clinical trial is looking at a medication called Daphnetin, which will be given in capsule form to patients experiencing vascular cognitive impairment (VCI) without dementia. VCI refers to problems with thinking and memory that are caused by reduced blood flow to the brain, but do not meet the criteria for dementia. The main goal of the trial is to see if Daphnetin can help improve cognitive function over a six-month period compared to a placebo, which is a harmless pill with no active ingredients. Researchers will evaluate participants' cognitive abilities using a specific assessment tool at the beginning and after six months of treatment.

To be eligible for the trial, participants need to be between 50 and 80 years old and have been experiencing memory or thinking problems for at least three months. They should have a certain level of cognitive impairment, but not be diagnosed with dementia. Participants will take either the Daphnetin capsule or the placebo daily and will have check-in visits every three months. It's important to note that individuals with certain medical conditions or recent health issues, such as a stroke or severe mental illness, will not be able to participate. This study is currently not recruiting participants, so if you or someone you know is interested, keep an eye out for updates!

Gender

ALL

Eligibility criteria

• 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.