Clinical Observation for the Therapeutic Effect of mNGF on Cognitive Decline in Cerebral Small Vessel Disease

• Status: Recruiting
• Trial end date: 2021-02-28
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Zhujiang Hospital
• Collaborators: Dongguan People's Hospital; First Affiliated Hospital of Jinan University; First Affiliated Hospital of Shantou University Medical College; First Affiliated Hospital, Sun Yat-Sen University; Guangdong 999 Brain Hospital; Houjie Hospital of Dongguan City; Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University; The First Affiliated Hospital of Guangdong Pharmaceutical University; Wuhan University
• Treatments: Cholinesterase Inhibitors; Mitogens

Criteria

Inclusion Criteria:

1. Aged 50-80 years old;

2. 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);

3. 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);

4. Clinical diagnosis of vascular cognitive impairment or dementia, MMSE score =<26;

5. Signed informed consent.

Exclusion Criteria:

1. Intracranial or extracranial arterial stenosis of > 50% luminal stenosis or prior history of endarterectomy of cerebral large arteries;

2. TOAST classification suggested (very) possible cardioembolic stroke;

3. 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.;

4. History of alcohol intoxication, drug addiction, or mental disease, or severe aphasia;

5. Contraindication for MRI examination. -