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

October 30, 2020 updated by: Gao Xiaoya, Zhujiang Hospital
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 CSVD are complex and varied, but cognitive impairment is one of the core clinical manifestations of CSVD, and some patients have gait and sphincter dysfunction.At present, CSVD is an important subtype of vascular cognitive dysfunction and the most common cause of vascular dementia in clinic.Currently, the treatment of cognitive impairment in small cerebral vascular diseases is conducted in two aspects: the treatment and prevention of the structure and function of small cerebral vascular diseases, and the treatment of cognitive dysfunction.The treatments recommended by experts for cognitive dysfunction include cholinesterase inhibitors, nmda-receptor antagonists, and other drugs, but these drugs have not been specifically studied for the treatment of cognitive impairment in small cerebral vascular diseases.The treatment of cognitive impairment in small cerebral vascular disease is still in difficulty, and there is no effective and specific treatment at present.Mouse Nerve Growth Factor (mNGF) is a soluble protein which promotes Nerve Growth, isolated and purified successively by Levi-Montalcini and Cohen in 1959 and 1960.The discovery of NGF makes people realize that some factors are needed to promote the development, growth and maintain the activity of neurons in the process of nervous system, which opens up a new field of neurobiology, for which the two scholars won the 1986 Nobel Prize in physiology.Clinical use of NGF in the treatment of Alzheimer's Disease (AD), NGF injection into Meynert basal ganglia showed that NGF can improve the symptoms of AD and AD induced brain atrophy.Meynert basal ganglia is considered to be the main source of cholinergic neurons and plays an important role in the pathogenesis of AD and Parkinson's Disease (PD). Similar studies in China have also confirmed that nerve growth factor can reduce the symptoms of vascular dementia in stroke patients and delay the development of cognitive dysfunction.It has been found that nerve growth factor, like other special types of macromolecular proteins, can pass through the blood-brain barrier (BBB) through receptor-mediated endocytosis.In the animal studies, BBB integrity was significantly damaged in rats with hypertensive white matter lesions, in which case, nerve growth factor can play a role in protecting neurons, preventing cell apoptosis and promoting nerve reconstruction through BBB.By carrying out this study, the researchers intend to explore the therapeutic effect of rat nerve growth factor on cognitive dysfunction caused by cerebral small vascular disease, and preliminarily explore its imaging mechanism, so as to provide a new direction for further research on drug treatment of cognitive dysfunction caused by cerebral small vascular disease.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
50

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Xiaoya Gao, doctor
  • Phone Number: 86-18680282869
  • Email: gaoxy23@126.com

Study Contact Backup

  • Name: Xiaomei Liang
  • Phone Number: 86-13602497928
  • Email: nfylxm@163.com

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 510000
        • Recruiting
        • Zhujiang Hospiatal
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

50 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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. -

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
No Intervention: The standard treatment group
The standard treatment group is treated with conventional drugs and cholinesterase inhibitors
Experimental: mouse nerve growth factor (mNGF)group
Conventional drugs and cholinesterase inhibitors + mouse nerve growth factor (mNGF) of 20 μg (9000 U)/day for 14 consecutive days by intramuscular injection.
Drug: mouse nerve growth factor
mouse nerve growth factor of 20 UG (9000 U)/day for 14 consecutive days by intramuscular injection
Other Names:
  • mNGF

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
change of Alzheimer's disease assessment scale-cognition (ADAS-cog) score
Time Frame: Baseline -14 days -3 months
Cognitive function assessment
Baseline -14 days -3 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
change of Mini-mental State Examination (MMSE)
Time Frame: Baseline -14 days -3 months
Dementia screening scale
Baseline -14 days -3 months
Montreal Cognitive Assessment (MoCA) scale
Time Frame: Baseline -14 days -3 months
A rapid screening tool for mild cognitive impairment
Baseline -14 days -3 months
digit span test
Time Frame: Baseline -14 days -3 months
test the ability to concentrate attention, instantaneous memory and anti - information interference ability
Baseline -14 days -3 months
Activity of Daily Living Scale
Time Frame: Baseline -14 days -3 months
Barthel index was used to reflect the daily life ability of the interviewees
Baseline -14 days -3 months
Patient Health Questionnaire-9 Score
Time Frame: Baseline -14 days -3 months
Depression assessment tool
Baseline -14 days -3 months
Hamilton anxiety scale
Time Frame: Baseline -14 days -3 months
Assess the severity of anxiety symptoms in neurosis and other patients
Baseline -14 days -3 months
Hamilton depression scale
Time Frame: Baseline -14 days -3 months
A commonly used scale in clinical evaluation of depression
Baseline -14 days -3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Zhujiang Hospital

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Wuhan University
First Affiliated Hospital, Sun Yat-Sen University
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
First Affiliated Hospital of Jinan University
Dongguan People's Hospital
First Affiliated Hospital of Shantou University Medical College
Guangdong 999 Brain Hospital
The First Affiliated Hospital of Guangdong Pharmaceutical University
Houjie Hospital of Dongguan City

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Xiaoya Gao, Doctor, Zhujiang Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 7, 2019

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 30, 2020

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 28, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 9, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 31, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 1, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 2, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 30, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2019-KY-026-02

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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