Clinical Observation for the Therapeutic Effect of mNGF on Cognitive Decline in Cerebral Small Vessel Disease
1 other identifier
interventional
50
1 country
1
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 randomly included in multiple centers and randomized into two groups (standard treatment group and mouse nerve growth factor addition treatment group). The standard treatment group is treated with conventional drugs and cholinesterase inhibitors. In addition to the above treatment, the mouse nerve growth factor addition treatment group is administered with nerve growth factor 20 μg (9000 U)/vial for 14 consecutive days, intramuscularly once a day. Systematic clinical evaluation of patient cognitive function is performed at baseline, 14-day, and 3-month follow-up, and imaging (MR) is also evaluated twice at baseline, 14-day, and 3-month follow-up. At last observe the clinical effect of mouse nerve growth factor on cognitive impairment of cerebral small vessel disease.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4
Started Sep 2019
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 9, 2019
CompletedFirst Posted
Study publicly available on registry
August 1, 2019
CompletedStudy Start
First participant enrolled
September 7, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 30, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
February 28, 2021
CompletedNovember 2, 2020
October 1, 2020
1.2 years
July 9, 2019
October 30, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
change of Alzheimer's disease assessment scale-cognition (ADAS-cog) score
Cognitive function assessment
Baseline -14 days -3 months
Secondary Outcomes (7)
change of Mini-mental State Examination (MMSE)
Baseline -14 days -3 months
Montreal Cognitive Assessment (MoCA) scale
Baseline -14 days -3 months
digit span test
Baseline -14 days -3 months
Activity of Daily Living Scale
Baseline -14 days -3 months
Patient Health Questionnaire-9 Score
Baseline -14 days -3 months
- +2 more secondary outcomes
Study Arms (2)
The standard treatment group
NO INTERVENTIONThe standard treatment group is treated with conventional drugs and cholinesterase inhibitors
mouse nerve growth factor (mNGF)group
EXPERIMENTALConventional drugs and cholinesterase inhibitors + mouse nerve growth factor (mNGF) of 20 μg (9000 U)/day for 14 consecutive days by intramuscular injection.
Interventions
mouse nerve growth factor of 20 UG (9000 U)/day for 14 consecutive days by intramuscular injection
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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. -
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Zhujiang Hospitallead
- First Affiliated Hospital, Sun Yat-Sen Universitycollaborator
- Sun Yat-Sen Memorial Hospital of Sun Yat-Sen Universitycollaborator
- First Affiliated Hospital of Jinan Universitycollaborator
- Guangdong 999 Brain Hospitalcollaborator
- Dongguan People's Hospitalcollaborator
- Houjie Hospital of Dongguan Citycollaborator
- First Affiliated Hospital of Shantou University Medical Collegecollaborator
- Wuhan Universitycollaborator
- The First Affiliated Hospital of Guangdong Pharmaceutical Universitycollaborator
Study Sites (1)
Zhujiang Hospiatal
Guangzhou, Guangdong, 510000, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Xiaoya Gao, Doctor
Zhujiang Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Chief Physician
Study Record Dates
First Submitted
July 9, 2019
First Posted
August 1, 2019
Study Start
September 7, 2019
Primary Completion
November 30, 2020
Study Completion
February 28, 2021
Last Updated
November 2, 2020
Record last verified: 2020-10
Data Sharing
- IPD Sharing
- Will not share