MAPT Haploid H1b and the Damage of BBB in Dorsal Medulla Oblongata and Autonomic Dysfunction in PD
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
1 other identifier
observational
80
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Jan 2022
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2022
CompletedFirst Submitted
Initial submission to the registry
June 8, 2022
CompletedFirst Posted
Study publicly available on registry
July 25, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 30, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
December 30, 2023
CompletedJuly 25, 2022
May 1, 2022
2 years
June 8, 2022
July 22, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
MAPT genotype
MAPT mainly has two extended haplotypes (H1 and H2) .
baseline
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
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
Study Arms (2)
PD with AutD
Parkinson's disease with autonomic dysfunction
PD without AutD
Parkinson's disease without autonomic dysfunction
Interventions
Eligibility Criteria
Patients with primary Parkinson's disease.
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Zhujiang Hospital of Southern Medical University
Guangzhou, Guangdong, 510000, China
Biospecimen
Microtubule associated protein tau (MAPT ) gene is located in 17q21.3 and contains 16 exons Due to the linkage disequilibrium inheritance of genes, MAPT mainly has two extended haplotypes (H1 and H2). This gene is responsible for encoding the neuronal microtubule associated protein tau, which is mainly distributed in the axons of neurons and plays an important role in the stability and assembly of microtubules. The gene polymorphism of MAPT is related to the clinical subtype of PD, in which MAPT H1J is related to sleep behavior disorder during rapid eye movement, while the risk of postural hypotension in H1B patients is increased by 1.72 times. The above studies suggest that the gene subtype of MAPT may be related to the occurrence and progression of early autd in PD patients.
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
shuzhen zhu, doctor
Southern Medical University, China
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- CROSS SECTIONAL
- Target Duration
- 6 Months
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 8, 2022
First Posted
July 25, 2022
Study Start
January 1, 2022
Primary Completion
December 30, 2023
Study Completion
December 30, 2023
Last Updated
July 25, 2022
Record last verified: 2022-05