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

NCT04041349 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2020-11-02

No results posted yet for this study

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.

Conditions

  • Cerebral Small Vessel Diseases

Interventions

DRUG

mouse nerve growth factor

mouse nerve growth factor of 20 UG (9000 U)/day for 14 consecutive days by intramuscular injection

Sponsors & Collaborators

  • First Affiliated Hospital, Sun Yat-Sen University

    collaborator OTHER

  • Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

    collaborator OTHER

  • First Affiliated Hospital of Jinan University

    collaborator OTHER

  • Guangdong 999 Brain Hospital

    collaborator OTHER

  • Dongguan People's Hospital

    collaborator OTHER_GOV

  • Houjie Hospital of Dongguan City

    collaborator UNKNOWN

  • First Affiliated Hospital of Shantou University Medical College

    collaborator OTHER

  • Wuhan University

    collaborator OTHER

  • The First Affiliated Hospital of Guangdong Pharmaceutical University

    collaborator OTHER

  • Zhujiang Hospital

    lead OTHER

Principal Investigators

  • Xiaoya Gao, Doctor · Zhujiang Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
50 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-09-07
Primary Completion
2020-11-30
Completion
2021-02-28

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04041349 on ClinicalTrials.gov