Trial Outcomes & Findings for Multi-chip Meta-analysis of Parkinson's Disease for Clinical Validation of Small Samples of Key Genes in Disease (NCT NCT03848455)
NCT ID: NCT03848455
Last Updated: 2023-07-28
Results Overview
The blood of patients were taken for genetic testing and relative expression levels of the genes(These genes expression relative to a house keeping gene:GAPDH) for PPP2CA, PPP3CB, SYNJ1, NSF were extracted.The method we used is RT-PCR.
Recruitment status
COMPLETED
Target enrollment
238 participants
Primary outcome timeframe
3 days
Results posted on
2023-07-28
Participant Flow
Participant milestones
| Measure |
Healthy Controls
healthy group inclusion criteria: age, gender-matched PD group, non-PD, non-PDS, non-neurological degenerative disease, patients without inflammatory disease and related family history; informed consent to the study; age \> 18 older.
genetic diagnosis: The venous blood of the three groups of patients was taken for genetic testing, and the expression levels of PPP2CA, PPP3CB, SYNJ1, NSF and CYCS were extracted by pre-processing the genetic data of PD and PPS patients and healthy controls .
|
Parkinson's Disease Group
1. Patients who meet the 2016 China Parkinson's diagnostic criteria and the 2015 International Parkinson's and Movement Disorders Association (MDS) Parkinson's disease diagnostic criteria;
2. Newly diagnosed primary PD patients, diagnosed within 3-6 months;
3. informed consent to the study;
4. age \> 18 older.
genetic diagnosis: The venous blood of the three groups of patients was taken for genetic testing, and the expression levels of PPP2CA, PPP3CB, SYNJ1, NSF and CYCS were extracted by pre-processing the genetic data of PD ,PPS patients and healthy controls.
|
Parkinson-plus Syndrome Group
1\. patients with Parkinson-plus syndrome were diagnosed according to 2017 MDS progressive supranuclear paralysis and 2017 clinical diagnostic criteria for MDS progressive supra palsy (PSP patients) and Giman standard, the 2008 American board of neurology (AAN) MSA diagnostic consensus.2.informed consent to the study; 3.age \> 18 older.
genetic diagnosis: The venous blood of the three groups of patients was taken for genetic testing, and the expression levels of PPP2CA, PPP3CB, SYNJ1, NSF and CYCS were extracted by pre-processing the genetic data of PD and PPS patients and healthy controls .
|
|---|---|---|---|
|
Overall Study
STARTED
|
125
|
90
|
23
|
|
Overall Study
COMPLETED
|
125
|
90
|
23
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Multi-chip Meta-analysis of Parkinson's Disease for Clinical Validation of Small Samples of Key Genes in Disease
Baseline characteristics by cohort
| Measure |
Parkinson's Disease Group
n=90 Participants
1. Patients who meet the 2016 China Parkinson's diagnostic criteria and the 2015 International Parkinson's and Movement Disorders Association (MDS) Parkinson's disease diagnostic criteria;
2. Newly diagnosed primary PD patients, diagnosed within 3-6 months;
3. informed consent to the study;
4. age \> 18 older.
genetic diagnosis: The venous blood of the three groups of patients was taken for genetic testing, and the expression levels of PPP2CA, PPP3CB, SYNJ1, NSF and CYCS were extracted by pre-processing the genetic data of PD ,PPS patients and healthy controls.
|
Healthy Controls
n=125 Participants
healthy group inclusion criteria: age, gender-matched PD group, non-PD, non-PDS, non-neurological degenerative disease, patients without inflammatory disease and related family history; informed consent to the study; age \> 18 older.
genetic diagnosis: The venous blood of the three groups of patients was taken for genetic testing, and the expression levels of PPP2CA, PPP3CB, SYNJ1, NSF and CYCS were extracted by pre-processing the genetic data of PD and PPS patients and healthy controls .
|
Parkinson-plus Syndrome Group
n=23 Participants
1\. patients with Parkinson-plus syndrome were diagnosed according to 2017 MDS progressive supranuclear paralysis and 2017 clinical diagnostic criteria for MDS progressive supra palsy (PSP patients) and Giman standard, the 2008 American board of neurology (AAN) MSA diagnostic consensus.2.informed consent to the study; 3.age \> 18 older.
genetic diagnosis: The venous blood of the three groups of patients was taken for genetic testing, and the expression levels of PPP2CA, PPP3CB, SYNJ1, NSF and CYCS were extracted by pre-processing the genetic data of PD and PPS patients and healthy controls .
|
Total
n=238 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
46 Participants
n=99 Participants
|
71 Participants
n=107 Participants
|
16 Participants
n=206 Participants
|
133 Participants
n=7 Participants
|
|
Age, Categorical
>=65 years
|
44 Participants
n=99 Participants
|
54 Participants
n=107 Participants
|
7 Participants
n=206 Participants
|
105 Participants
n=7 Participants
|
|
Age, Continuous
|
63.66 years
STANDARD_DEVIATION 11.94 • n=99 Participants
|
63.42 years
STANDARD_DEVIATION 10.99 • n=107 Participants
|
62.30 years
STANDARD_DEVIATION 8.13 • n=206 Participants
|
63.40 years
STANDARD_DEVIATION 11.09 • n=7 Participants
|
|
Sex: Female, Male
Female
|
34 Participants
n=99 Participants
|
59 Participants
n=107 Participants
|
15 Participants
n=206 Participants
|
108 Participants
n=7 Participants
|
|
Sex: Female, Male
Male
|
56 Participants
n=99 Participants
|
66 Participants
n=107 Participants
|
8 Participants
n=206 Participants
|
130 Participants
n=7 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
90 Participants
n=99 Participants
|
125 Participants
n=107 Participants
|
23 Participants
n=206 Participants
|
238 Participants
n=7 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Asian
|
90 Participants
n=99 Participants
|
125 Participants
n=107 Participants
|
23 Participants
n=206 Participants
|
238 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Region of Enrollment
China
|
90 Participants
n=99 Participants
|
125 Participants
n=107 Participants
|
23 Participants
n=206 Participants
|
238 Participants
n=7 Participants
|
PRIMARY outcome
Timeframe: 3 daysThe blood of patients were taken for genetic testing and relative expression levels of the genes(These genes expression relative to a house keeping gene:GAPDH) for PPP2CA, PPP3CB, SYNJ1, NSF were extracted.The method we used is RT-PCR.
Outcome measures
| Measure |
Parkinson's Disease Group
n=90 Participants
1. Patients who meet the 2016 China Parkinson's diagnostic criteria and the 2015 International Parkinson's and Movement Disorders Association (MDS) Parkinson's disease diagnostic criteria;
2. Newly diagnosed primary PD patients, diagnosed within 3-6 months;
3. informed consent to the study;
4. age \> 18 older.
genetic diagnosis: The venous blood of the three groups of patients was taken for genetic testing, and the expression levels of PPP2CA, PPP3CB, SYNJ1, NSF and CYCS were extracted by pre-processing the genetic data of PD ,PPS patients and healthy controls.
|
Healthy Controls
n=125 Participants
healthy group inclusion criteria: age, gender-matched PD group, non-PD, non-PDS, non-neurological degenerative disease, patients without inflammatory disease and related family history; informed consent to the study; age \> 18 older.
genetic diagnosis: The venous blood of the three groups of patients was taken for genetic testing, and the expression levels of PPP2CA, PPP3CB, SYNJ1, NSF and CYCS were extracted by pre-processing the genetic data of PD and PPS patients and healthy controls .
|
Parkinson-plus Syndrome Group
n=23 Participants
1\. patients with Parkinson-plus syndrome were diagnosed according to 2017 MDS progressive supranuclear paralysis and 2017 clinical diagnostic criteria for MDS progressive supra palsy (PSP patients) and Giman standard, the 2008 American board of neurology (AAN) MSA diagnostic consensus.2.informed consent to the study; 3.age \> 18 older.
genetic diagnosis: The venous blood of the three groups of patients was taken for genetic testing, and the expression levels of PPP2CA, PPP3CB, SYNJ1, NSF and CYCS were extracted by pre-processing the genetic data of PD and PPS patients and healthy controls .
|
|---|---|---|---|
|
Parkinson's Key Gene
PPP2CA
|
1.502 gene expression relative to GAPDH
Interval 0.718 to 3.11
|
3.653 gene expression relative to GAPDH
Interval 1.99 to 5.856
|
0.916 gene expression relative to GAPDH
Interval 0.654 to 1.452
|
|
Parkinson's Key Gene
PPP3CB
|
1.669 gene expression relative to GAPDH
Interval 0.792 to 2.947
|
2.237 gene expression relative to GAPDH
Interval 0.903 to 4.416
|
2.320 gene expression relative to GAPDH
Interval 1.11 to 3.269
|
|
Parkinson's Key Gene
SYNJ1
|
0.924 gene expression relative to GAPDH
Interval 0.537 to 1.585
|
4.662 gene expression relative to GAPDH
Interval 2.278 to 7.452
|
5.206 gene expression relative to GAPDH
Interval 2.541 to 6.15
|
|
Parkinson's Key Gene
NSF
|
1.002 gene expression relative to GAPDH
Interval 0.513 to 2.15
|
3.058 gene expression relative to GAPDH
Interval 1.665 to 4.909
|
1.408 gene expression relative to GAPDH
Interval 0.864 to 2.689
|
PRIMARY outcome
Timeframe: 2 daysPopulation: The "Unified Parkinson's Disease Rating Scale 3.0" is just suitable for PD patients,so there are no relative result for the group of healthy controls and Parkinson-plus syndrome group.
The total score ranges from 0 to 199( minimum score is 0 and maximum scores is 199), in which a lower score denotes a better perception of the patient's. Scoring the mental, behavioral and emotional, daily living activities, exercise tests, and drug treatment complications associated with UPDRS3.0 in patients with Parkinson's disease;each item 0-4 points, total score 199 points, 0-50 points: limb and body mild dysfunction, posture response normal;51-100 points: mild postural reaction disorder, self-care in daily life, loss of labor force;101-199: obvious postural reaction disorder, loss of daily life and labor force, may need help to get up and confined to wheelchair life;The more severe the symptoms of Parkinson's disease, the higher the score.
Outcome measures
| Measure |
Parkinson's Disease Group
n=90 Participants
1. Patients who meet the 2016 China Parkinson's diagnostic criteria and the 2015 International Parkinson's and Movement Disorders Association (MDS) Parkinson's disease diagnostic criteria;
2. Newly diagnosed primary PD patients, diagnosed within 3-6 months;
3. informed consent to the study;
4. age \> 18 older.
genetic diagnosis: The venous blood of the three groups of patients was taken for genetic testing, and the expression levels of PPP2CA, PPP3CB, SYNJ1, NSF and CYCS were extracted by pre-processing the genetic data of PD ,PPS patients and healthy controls.
|
Healthy Controls
healthy group inclusion criteria: age, gender-matched PD group, non-PD, non-PDS, non-neurological degenerative disease, patients without inflammatory disease and related family history; informed consent to the study; age \> 18 older.
genetic diagnosis: The venous blood of the three groups of patients was taken for genetic testing, and the expression levels of PPP2CA, PPP3CB, SYNJ1, NSF and CYCS were extracted by pre-processing the genetic data of PD and PPS patients and healthy controls .
|
Parkinson-plus Syndrome Group
1\. patients with Parkinson-plus syndrome were diagnosed according to 2017 MDS progressive supranuclear paralysis and 2017 clinical diagnostic criteria for MDS progressive supra palsy (PSP patients) and Giman standard, the 2008 American board of neurology (AAN) MSA diagnostic consensus.2.informed consent to the study; 3.age \> 18 older.
genetic diagnosis: The venous blood of the three groups of patients was taken for genetic testing, and the expression levels of PPP2CA, PPP3CB, SYNJ1, NSF and CYCS were extracted by pre-processing the genetic data of PD and PPS patients and healthy controls .
|
|---|---|---|---|
|
Unified Parkinson's Disease Rating Scale 3.0（UPDRS 3.0）
|
61.352 score on a scale
Standard Deviation 29.611
|
—
|
—
|
PRIMARY outcome
Timeframe: 2 daysPopulation: Data were not collected.
Scoring based on the patient's own situation in the last month Severity: 1 = mild; 2 = moderate; 3 = severe Frequency: 1 = very little (less than once a week); 2 = often (1 time a week); 3 = frequent (a few times a week); 4 = very frequent (every day or persist)
Outcome measures
Outcome data not reported
Adverse Events
Parkinson's Disease Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Healthy Controls
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Parkinson-plus Syndrome Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Xiaoya Gao
Zhujiang Hospital of Southern Medical University
Phone: 18680282869
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place