Clinical trial NCT05471713: MAPT Haploid H1b and the Damage of BBB in Dorsal Medulla Oblongata and Autonomic Dysfunction in PD
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
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Parkinson's Disease
Keywords: Parkinson's disease
MAPT genotype
autonomic dysfunction
blood brain barrier
Lead sponsor: Zhujiang Hospital
Sponsor class: OTHER
First posted: 2022-07-25
Enrollment: 80
Sex: ALL
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with primary Parkinson's disease.

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: MAPT genotype
timeFrame: baseline
measure: Dynamic changes of the permeability of blood-brain barrier in dorsal medulla oblongata
timeFrame: baseline,the sixth month,1year
measure: Dynamic changes of SCOPA-AUT scale
timeFrame: baseline,the sixth month,1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Zhujiang Hospital of Southern Medical University
state: Guangdong
Study officials:
affiliation: Southern Medical University, China
name: shuzhen zhu, doctor
role: PRINCIPAL_INVESTIGATOR
References: