MAPT Haploid H1b and the Damage of BBB in Dorsal Medulla Oblongata and Autonomic Dysfunction in PD

July 22, 2022 updated by: Zhujiang Hospital

Study on the Correlation Between MAPT Haploid H1b and the Damage of Blood-brain Barrier in Dorsal Medulla Oblongata and Autonomic Dysfunction in Parkinson's Disease

This study mainly explored the relationship between the permeability of the blood-brain barrier in the dorsal medulla oblongata and autonomic dysfunction, and the relationship and mechanism of MAPT genotype on the permeability of the blood-brain barrier and the progression of autonomic dysfunction in PD patients.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

According to the MDS 2015 clinical diagnostic criteria for Parkinson's disease and the diagnostic criteria for autonomic dysfunction (AutD), the patients were divided into PD with AutD group and PD without AutD group. DCE results, pet-pdrp+18f-dopa data and clinical evaluation (SCOPA-AUT, HRV and sleep EEG) were analyzed; Blood samples were collected to detect MAPT gene polymorphism, oligomers and phosphorylated synuclein. To explore the relationship between the permeability of the blood-brain barrier in the dorsal medulla oblongata and autonomic dysfunction, and the relationship and mechanism of MAPT genotype on the permeability of the blood-brain barrier and the progression of autonomic dysfunction in PD patients.

Study Type

Observational

Enrollment (Anticipated)

80

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 Backup

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 510000
        • Recruiting
        • ZhuJiang Hospital of Southern Medical University
        • 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

Ages Eligible for Study

45 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with primary Parkinson's disease.

Description

Inclusion Criteria:

  • Meet the diagnostic criteria for idiopathic PD of MDS 2015
  • Age ≥ 45 years old
  • Be able to complete various clinical evaluations and scales; Willing to participate in MRI, no contrast agent allergy

Exclusion Criteria:

  • Dementia was diagnosed before or 1 year after the onset of motor symptoms
  • Single gene form of PD
  • Coexisting neuropathological diagnosis considered to affect PD progression
  • Known complications affecting BBB (severe infection, cerebral infarction, etc.
  • Such as comorbidities known to affect the autonomic nervous system (e.g., diabetes gangliopathy or neuropathy)
  • Disturbance of consciousness, serious cerebral hemorrhage or cerebral thrombosis, serious brain tumor or brain surgery history, serious mental illness or other serious nervous system diseases, which are enough to seriously interfere with the subjects' motor and non motor symptoms
  • According to the judgment of the researcher, the researcher is unable to complete the research test according to the requirements of the research scheme.

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
PD with AutD
Parkinson's disease with autonomic dysfunction
Other: Autonomic dysfunction
Autonomic dysfunction
PD without AutD
Parkinson's disease without autonomic dysfunction

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
MAPT genotype
Time Frame: baseline
MAPT mainly has two extended haplotypes (H1 and H2) .
baseline
Dynamic changes of the permeability of blood-brain barrier in dorsal medulla oblongata
Time Frame: baseline,the sixth month,1year
Dynamic contrast-enhanced MRI is used to measure the permeability of blood-brain barrier in dorsal medulla oblongata.Dynamic contrast ⁃ enhanced (DCE) ⁃ MRI is a very valuable quantitative MRI technology, which plays a great role in clinical research. Quantitative analysis can calculate the contrast agent concentration in the region of interest, and then improve the comparability of different research results. The permeability of blood-brain barrier is calculated by the volume transfer constant (Ktrans) between plasma and extravascular-extracellular space.
baseline,the sixth month,1year
Dynamic changes of SCOPA-AUT scale
Time Frame: baseline,the sixth month,1 year
The Scales for Outcomes in Parkinson's Disease-Autonomic (SCOPA-AUT) is used to evaluate autonomic nerve dysfunction. The SCOPA-AUT consists of 25 items assessing the following regions: gastrointestinal (7), urinary (6), cardiovascular (3), thermoregulatory (4), pupillomotor (1), and sexual (2 items for men and 2 items for women) dysfunction.Higher scores mean more severe autonomic dysfunction, with a minimum score of 0 and a maximum of 69.
baseline,the sixth month,1 year

Collaborators and Investigators

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

Sponsor

Zhujiang Hospital

Investigators

  • Principal Investigator: shuzhen zhu, doctor, Southern Medical University, China

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)

January 1, 2022

Primary Completion (Anticipated)

December 30, 2023

Study Completion (Anticipated)

December 30, 2023

Study Registration Dates

First Submitted

June 8, 2022

First Submitted That Met QC Criteria

July 22, 2022

First Posted (Actual)

July 25, 2022

Study Record Updates

Last Update Posted (Actual)

July 25, 2022

Last Update Submitted That Met QC Criteria

July 22, 2022

Last Verified

May 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2022-KY-034-01

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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