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

Parkinson's Disease Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05471713
• Other study ID #: 2022-KY-034-01
• Status: Recruiting
• Start date: January 1, 2022
• Est. completion date: December 30, 2023

Study information

• Verified date: May 2022
• Source: Zhujiang Hospital
• Contact: shuzhen zhu, doctor
• Phone: 86-020-783071
• Email: 453951712[@]qq.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: December 30, 2023
• Est. primary completion date: December 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 45 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Autonomic Nervous System Diseases
• Parkinson Disease
• Parkinson's Disease
• Primary Dysautonomias

Intervention

Other:
• Autonomic dysfunction
Autonomic dysfunction

Locations

Country	Name	City	State
China	Zhujiang Hospital of Southern Medical University	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Zhujiang Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	MAPT genotype	MAPT mainly has two extended haplotypes (H1 and H2) .	baseline
Primary	Dynamic changes of the permeability of blood-brain barrier in dorsal medulla oblongata	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
Primary	Dynamic changes of SCOPA-AUT scale	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