Status:
UNKNOWN
Clinical Observation for the Therapeutic Effect of mNGF on Cognitive Decline in Cerebral Small Vessel Disease
Lead Sponsor:
Zhujiang Hospital
Collaborating Sponsors:
First Affiliated Hospital, Sun Yat-Sen University
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Conditions:
Cerebral Small Vessel Diseases
Eligibility:
All Genders
50-80 years
Phase:
PHASE4
Brief Summary
This study was a multicenter, prospective, randomized controlled trial. In this study, 510 patients with cognitive impairment of cerebral small vessel disease who met the inclusion criteria are random...
Detailed Description
Cerebral small vessel disease (CSVD) refers to the disease that involves cerebral small blood vessels, including arterioles, arterioles, capillaries, and venules, etc.The clinical manifestations of CS...
Eligibility Criteria
Inclusion
- Aged 50-80 years old;
- Clinical symptoms of acute CSVD, including Transient ischemic attack (TIA) or lacunar infarction, and with related lesions on MRI imaging (acute infarction with diameter \< 20mm on (diffusion weighted imaging) DWI or with diameter of 3-15mm on MRI-T1,T2 or FLAIR);
- For patients with chronic CSVD symptoms, two or more CSVD imaging markers are required : lacune (number \> = 1), white matter lesion (Fazekas \> = 2), cerebral microbleeds (number \> =1 in deep white matter), enlarged perivascular space(number \> = 10 in basal ganglia);
- Clinical diagnosis of vascular cognitive impairment or dementia, MMSE score =\<26;
- Signed informed consent.
Exclusion
- Intracranial or extracranial arterial stenosis of \> 50% luminal stenosis or prior history of endarterectomy of cerebral large arteries;
- TOAST classification suggested (very) possible cardioembolic stroke;
- Large cortical or subcortical infarction with diameter \> 1.5cm on MRI; White matter lesions caused by other diseases such as multiple sclerosis; Other central nervous system diseases such as cerebral hemorrhage, brain trauma, epilepsy, encephalitis, hydrocephalus or brain tumors; Oher systemic diseases, such as liver and kidney insufficiency, tumor, etc.;
- History of alcohol intoxication, drug addiction, or mental disease, or severe aphasia;
- Contraindication for MRI examination. -
Key Trial Info
Start Date :
September 7 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 28 2021
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT04041349
Start Date
September 7 2019
End Date
February 28 2021
Last Update
November 2 2020
Active Locations (1)
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1
Zhujiang Hospiatal
Guangzhou, Guangdong, China, 510000