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

Sponsor
Zhujiang Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT05471713
Collaborator
(none)
80
1
23.9
3.3

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Autonomic dysfunction

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 Design

Study Type:
Observational [Patient Registry]
Anticipated Enrollment :
80 participants
Observational Model:
Case-Control
Time Perspective:
Cross-Sectional
Official Title:
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
Actual Study Start Date :
Jan 1, 2022
Anticipated Primary Completion Date :
Dec 30, 2023
Anticipated Study Completion Date :
Dec 30, 2023

Arms and Interventions

Arm 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

Outcome Measures

Primary Outcome Measures

  1. MAPT genotype [baseline]

    MAPT mainly has two extended haplotypes (H1 and H2) .

  2. Dynamic changes of the permeability of blood-brain barrier in dorsal medulla oblongata [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.

  3. Dynamic changes of SCOPA-AUT scale [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
45 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Zhujiang Hospital of Southern Medical University Guangzhou Guangdong China 510000

Sponsors and Collaborators

  • Zhujiang Hospital

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Zhujiang Hospital
ClinicalTrials.gov Identifier:
NCT05471713
Other Study ID Numbers:
  • 2022-KY-034-01
First Posted:
Jul 25, 2022
Last Update Posted:
Jul 25, 2022
Last Verified:
May 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Zhujiang Hospital
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jul 25, 2022