Trial Outcomes & Findings for Evaluation of Clinical Decision Support System-mPDia for Neurodegenerative Parkinsonism Using MRI Images (NCT NCT04334902)
NCT ID: NCT04334902
Last Updated: 2025-10-29
Results Overview
Sensitivity of mPDia in diagnosing neurodegenerative parkinsonism, based on comparison with the golden standard (final clinical diagnosis determined by specialist groups). Sensitivity was calculated as TP/(TP+FN) Sensitivity: 100 x True positive(TP)/ \[True positive(TP) + False negative(FN)\] (%)
COMPLETED
221 participants
At Visit 2 (within 4 weeks after Visit 1)
2025-10-29
Participant Flow
The data will be collected retrospectively from person whose past 3T nigrosome 1 MRI image, 18F FP-CIT PET/CT image, image interpretation, and neurologic exam results are confirmed by medical records, and those whose diagnosis as neurodegenerative Parkinsonism is confirmed. Data collecting must be executed following therandom collection. Only the verified researcher who is registered in this study will have access to medical records.
At each Institution, participants who met all inclusion and exclusion criteria for this study were randomly selected up to the target number of participants. Based on the medical record diagnosis of neurodegenerative parkinsonism, participants were classified into the normal group or the patient group. The data from the randomly selected participants were used for diagnostic evaluation.
Participant milestones
| Measure |
Abnormal
The person who visits parkinsonism symptoms and has been diagnosed with neurodegenerative parkinsonism
|
Normal
The person who presented with parkinsonism symptoms but were determined not to have neurodegenerative parkinsonism.
|
|---|---|---|
|
Overall Study
STARTED
|
159
|
62
|
|
Overall Study
COMPLETED
|
158
|
60
|
|
Overall Study
NOT COMPLETED
|
1
|
2
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Since this clinical trial is not a parallel design comparing two groups, comparative analysis of basic data and test results between the normal group and the patient group was not conducted.
Baseline characteristics by cohort
| Measure |
Abnormal
n=158 Participants
The person who visits parkinsonism symptoms and has been diagnosed with neurodegenerative parkinsonism
|
Normal
n=60 Participants
The person who visits parkinsonism symptoms but is not or is normal for neurodegenerative parkinsonism
|
Total
n=218 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Sex: Female, Male
Female
|
83 Participants
n=158 Participants • Since this clinical trial is not a parallel design comparing two groups, comparative analysis of basic data and test results between the normal group and the patient group was not conducted.
|
36 Participants
n=60 Participants • Since this clinical trial is not a parallel design comparing two groups, comparative analysis of basic data and test results between the normal group and the patient group was not conducted.
|
119 Participants
n=218 Participants • Since this clinical trial is not a parallel design comparing two groups, comparative analysis of basic data and test results between the normal group and the patient group was not conducted.
|
|
Sex: Female, Male
Male
|
75 Participants
n=158 Participants • Since this clinical trial is not a parallel design comparing two groups, comparative analysis of basic data and test results between the normal group and the patient group was not conducted.
|
24 Participants
n=60 Participants • Since this clinical trial is not a parallel design comparing two groups, comparative analysis of basic data and test results between the normal group and the patient group was not conducted.
|
99 Participants
n=218 Participants • Since this clinical trial is not a parallel design comparing two groups, comparative analysis of basic data and test results between the normal group and the patient group was not conducted.
|
|
Age, Continuous
|
65.85 year
STANDARD_DEVIATION 10.50 • n=158 Participants
|
68.35 year
STANDARD_DEVIATION 8.04 • n=60 Participants
|
66.54 year
STANDARD_DEVIATION 9.93 • n=218 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
PRIMARY outcome
Timeframe: At Visit 2 (within 4 weeks after Visit 1)Population: Sensitivity is calculated only in the Abnormal group (patients diagnosed with neurodegenerative parkinsonism). The Normal group is not applicable for this analysis, therefore the number of participants analyzed is recorded as 0.
Sensitivity of mPDia in diagnosing neurodegenerative parkinsonism, based on comparison with the golden standard (final clinical diagnosis determined by specialist groups). Sensitivity was calculated as TP/(TP+FN) Sensitivity: 100 x True positive(TP)/ \[True positive(TP) + False negative(FN)\] (%)
Outcome measures
| Measure |
Abnormal
n=158 Participants
The person who visits parkinsonism symptoms and has been diagnosed with neurodegenerative parkinsonism
|
Normal
The person who presented with parkinsonism symptoms but were determined not to have neurodegenerative parkinsonism.
|
|---|---|---|
|
Sensitivity of mPDia for the Diagnosis of Neurodegenerative Parkinsonism
|
94.30 percentage
Interval 90.69 to 97.92
|
—
|
PRIMARY outcome
Timeframe: At Visit 2 (within 4 weeks after Visit 1)Population: Specificity is calculated only in the Normal group (participants without neurodegenerative parkinsonism). The Abnormal group is not applicable for this analysis, therefore the number of participants analyzed is recorded as 0.
Specificity of mPDia in diagnosing neurodegenerative parkinsonism, based on comparison with the golden standard (final clinical diagnosis determined by specialist groups). Specificity was calculated as True Negative / (True Negative + False Positive) Specificity: 100 x True negative(TN)/\[False positive(FP) + True negative(TN)\] (%)
Outcome measures
| Measure |
Abnormal
The person who visits parkinsonism symptoms and has been diagnosed with neurodegenerative parkinsonism
|
Normal
n=60 Participants
The person who presented with parkinsonism symptoms but were determined not to have neurodegenerative parkinsonism.
|
|---|---|---|
|
Specificity of mPDia for the Diagnosis of Neurodegenerative Parkinsonism
|
—
|
91.67 percentage
Interval 84.67 to 98.66
|
Adverse Events
Abnormal
Normal
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place