Ignite Creation Date:
2024-10-26 @ 3:35 PM
Last Modification Date:
2024-10-26 @ 3:35 PM
Study NCT ID:
NCT06507488
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-07-12
Brief Title:
Daphnetin Capsule In the Treatment of VaScular COgnitive Impairment Without Dementia
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Daphnetin Capsule In the Treatment of VaScular COgnitive Impairment Without Dementia - A Randomized Double-blind Placebo-controlled Study
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
DISCO
Brief Summary:
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-cogVADAS-cog at 6 months were evaluated Although Daphnetin has a dual neurovascular protective effect however there is still a lack of relevant high-quality studies on its role in patients with vascular cognitive impairment especially in patients with vascular cognitive impairment in non-dementia VCI-ND whether it has a role in improving cognitive status needs to be urgently explored in high-quality clinical studies Researchers are comparing Daphnetin to placebo a drug-free analog to see if Daphnetin is effective in treating vascular cognitive impairment Participants will take either Daphnetin or placebo daily for six months with follow-up visits every three months and completion of a case report form
Detailed Description:
Vascular cognitive impairment VCI is caused by ischemic or hemorrhagic strokes and other cerebrovascular diseases leading to cognitive and memory function impairment With the aging population and high incidence of cerebrovascular diseases in China Vascular cognitive impairment VCI prevalence is rising increasing the disease burden However due to the complexity of Vascular cognitive impairment VCI symptoms and imaging changes targeted therapies are currently lacking
Daphnetin a coumarin derivative has shown promise in treating various diseases and has gained significant attention recently It offers triple protection for blood blood vessels and ischemic tissues by inhibiting inflammation anticoagulation and thrombosis protecting endothelial structures and regulating vasoactive substances Daphnetin is particularly beneficial for cardio-cerebral vascular disease diabetes mellitus and microvascular complications It also expands peripheral blood vessels improving circulation and alleviating vascular occlusive diseases
Research indicates that Daphnetins anti-inflammatory effects can inhibit neuroinflammation promote synaptic growth and enhance neuronal survival protecting nerve cells and repairing damage Despite these benefits there is a lack of high-quality studies on Daphnetins role in non-dementia vascular cognitive impairment VCI-ND
This project aims to evaluate the clinical efficacy and safety of oral Daphnetin capsules in treating Vascular cognitive impairment VCI through a prospective randomized double-blind placebo-controlled study Patients with vascular cognitive dysfunction confirmed by cerebral small vessel disease imaging will participate The study will follow the international FINESSE framework comparing Daphnetin to a placebo over six months with follow-up visits and case report forms completed every three months
Daphnetin a coumarin derivative has shown promise in treating various diseases and has gained significant attention recently It offers triple protection for blood blood vessels and ischemic tissues by inhibiting inflammation anticoagulation and thrombosis protecting endothelial structures and regulating vasoactive substances Daphnetin is particularly beneficial for cardio-cerebral vascular disease diabetes mellitus and microvascular complications It also expands peripheral blood vessels improving circulation and alleviating vascular occlusive diseases
Research indicates that Daphnetins anti-inflammatory effects can inhibit neuroinflammation promote synaptic growth and enhance neuronal survival protecting nerve cells and repairing damage Despite these benefits there is a lack of high-quality studies on Daphnetins role in non-dementia vascular cognitive impairment VCI-ND
This project aims to evaluate the clinical efficacy and safety of oral Daphnetin capsules in treating Vascular cognitive impairment VCI through a prospective randomized double-blind placebo-controlled study Patients with vascular cognitive dysfunction confirmed by cerebral small vessel disease imaging will participate The study will follow the international FINESSE framework comparing Daphnetin to a placebo over six months with follow-up visits and case report forms completed every three months
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None