UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000032474 |
|---|---|
| Receipt number | R000037029 |
| Scientific Title | Mild cognitive impairment in Parkinson's disease: the voxel-based QSM analysis |
| Date of disclosure of the study information | 2018/05/05 |
| Last modified on | 2024/11/08 09:15:18 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Mild cognitive impairment in Parkinson's disease: the voxel-based QSM analysis
Acronym
Mild cognitive impairment in Parkinson's disease: the voxel-based QSM analysis
Scientific Title
Mild cognitive impairment in Parkinson's disease: the voxel-based QSM analysis
Scientific Title:Acronym
Mild cognitive impairment in Parkinson's disease: the voxel-based QSM analysis
Region
| Japan |
Condition
Condition
Parkinson's disease
Classification by specialty
| Neurology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To explore the quantitative susceptibility mapping (QSM) value, a magnetic resonance imaging method which is sensitive to tissue iron, in Parkinson's disease with cognitive dysfunctions.
Basic objectives2
Others
Basic objectives -Others
we applied the voxel-based QSM to PD with dementia, mild cognitive impairment and normal cognitive subjects.
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
QSM value
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 60 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
PD-MCI group
Age> 60
HY stage 2-4
CDR 0-0.5
The diagnosis of PD-MCI was made based on MDS Task Force criteria.
Key exclusion criteria
Other primary explanations for cognitive impairment.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Yuto |
| Middle name | |
| Last name | Uchida |
Organization
Nagoya City University
Division name
Neurology
Zip code
467-8601
Address
1 Kawasumi, Mizuho-ku, Nagoya
TEL
052-853-8094
uchidayuto0720@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Yuto |
| Middle name | |
| Last name | Uchida |
Organization
Nagoya City University
Division name
Neurology
Zip code
467-8601
Address
1 Kawasumi, Mizuho-ku, Nagoya
TEL
052-853-8094
Homepage URL
uchidayuto0720@yahoo.co.jp
Sponsor or person
Institute
Department of Neurology, Nagoya City Universtiy
Institute
Department
Personal name
Funding Source
Organization
This work was supported by KAKENHI, Grant-in-Aid for Scientific Research on Innovative Areas, "Willdynamics" (16H06403).
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Nagoya City University
Address
1 Kawasumi, Mizuho-ku, Nagoya
Tel
052-853-8094
uchidayuto0720@yahoo.co.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 05 | Month | 05 | Day |
Related information
URL releasing protocol
https://center6.umin.ac.jp/cgi-open-bin/icdr/ctr_view.cgi?recptno=R000037029
Publication of results
Unpublished
Result
URL related to results and publications
doi: 10.1002/mds.27717.
Number of participants that the trial has enrolled
66
Results
The PD and mild cognitive impairment group had lower Montreal Cognitive Assessment (MoCA) scores than the PD and normal cognition and healthy control groups.
In contrast, the voxel-based quantitative susceptibility mapping analysis showed that the PD and mild cognitive impairment group had significantly higher quantitative susceptibility mapping values in the cuneus, precuneus, caudate head, fusiform gyrus, and orbitofrontal cortex than did the PD and normal cognition group.
Results date posted
| 2024 | Year | 11 | Month | 08 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
The participants fulfilled the following inclusion criteria: a clinical dementia rating <1, age >50 years, Hoehn and Yahr stage <5, and availability of results from a detailed neurological and comprehensive MRI examination.
Participant flow
The participants were recruited through advertisements on local bulletin boards.
Adverse events
NA
Outcome measures
Two senior movement disorder experts neurologically
examined the participants and evaluated the MDS Unified
Parkinson Disease Rating Scale (MDS-UPDRS).
The patients had discontinued antiparkinsonian medications
for at least 12 hours before clinical assessments.Cognitive
functions were globally assessed using the Montreal
Cognitive Assessment (MoCA). The MoCA comprises tests
of attention, visuospatial, verbal, and visual memory and is
well-suited to screen for cognitive impairment in PD.24 In
addition, a variety of executive functions, including flexibility,
working memory, and inhibition, were also assessed.
Briefly, these executive functions were measured using the
trail-making test (TMT), the digit span backward, and the
Stroop color-word test.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Open public recruiting
Date of protocol fixation
| 2017 | Year | 04 | Month | 01 | Day |
Date of IRB
| 2018 | Year | 03 | Month | 26 | Day |
Anticipated trial start date
| 2017 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
We applied quantitative susceptibility mapping (QSM), a magnetic resonance imaging method which is sensitive to tissue iron, to PD subjects.
Management information
Registered date
| 2018 | Year | 05 | Month | 05 | Day |
Last modified on
| 2024 | Year | 11 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037029
