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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000046104
Receipt No. R000033525
Scientific Title Neuroimaging study for the assessment and treatment of cognitive impairment of the patients with Parkinson's disease
Date of disclosure of the study information 2021/11/21
Last modified on 2021/11/17

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Basic information
Public title Research for the development of assessment strategy and treatment for cognitive impairment of Parkinson's disease
Acronym Research for the development of assessment strategy and treatment for cognitive impairment of Parkinson's disease
Scientific Title Neuroimaging study for the assessment and treatment of cognitive impairment of the patients with Parkinson's disease
Scientific Title:Acronym RCIP-Nagoya Study: Research for the cognitive impairment of Parkinson's disease in Nagoya
Region
Japan

Condition
Condition Parkinson's disease
Classification by specialty
Neurology Rehabilitation medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Mild cognitive impairment of Parkinson's disease (PD) represents increased risk of future cognitive decline. The characteristics of mild cognitive impairment of PD (PD-MCI) are impairments in executive function and visuospatial recognition. The visuospatial n-back test has a merit that it can assess both cognitive domains.

Using functional MRI, we explored the specific brain regions associated with the performance of the n-back test in the patients with PD-MCI, cognitive normal PD, and the age-matched healthy subjects. The 0-back test assesses visuospatial recognition, while the 1-back and 2-back tests assess visuospatial working memory. Group comparisons were performed for three loads of this test. Using this test and neuroimaging, we aimed to clarify the advantage of the visuospatial n-back test as a tool for detecting impairments of working memory in PD.
Basic objectives2 Others
Basic objectives -Others Efficacy of memantine for dementia in PD has been reported, however, therapeutic evidence of memantine for the mild cognitive impairment in PD has not been unestablished yet. Therefore, we aimed to investigate whether memantine can alter brain function of the patients with PD-MCI, using functional MRI. In comparison between memantine and placebo, we explored the difference in brain regions associated with visuospatial n-back test.
Trial characteristics_1 Exploratory
Trial characteristics_2 Explanatory
Developmental phase Not applicable

Assessment
Primary outcomes BOLD signals of the rest and task conditions during scanning of functional MRI
Key secondary outcomes Neuropsychological assessments

Base
Study type Interventional

Study design
Basic design Cross-over
Randomization Randomized
Randomization unit Individual
Blinding Double blind -all involved are blinded
Control Placebo
Stratification NO
Dynamic allocation NO
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 This study followed a randomized double-blind crossover design for the patients with mild cognitive impairments in PD. Patients in the memantine group were given memantine at 5 mg/day in the first week, and the dose was increased by 5 mg/day per week, with the final dose of 20 mg/day. The patients in the placebo group were given a placebo following the same regimen.
Interventions/Control_2 During maximum dose administration, fMRI scanning and neuropsychological tests were performed. Group comparisons between memantine and placebo were performed to explore the significant differences.
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
75 years-old >=
Gender Male and Female
Key inclusion criteria Patients with Parkinson's disease who had confirmed clinical diagnosis using United Kingdom Parkinson's Disease Brain Bank Criteria .
Key exclusion criteria Patients with dementia, or patients with abnormal findings of brain MRI except for PD, or patients using major psychotropic drugs, or patients with severe disturbance of hearing and/or eyesight.
Target sample size 12

Research contact person
Name of lead principal investigator
1st name Shoji
Middle name
Last name Kawashima
Organization Nagoya City University
Division name Department of neurology
Zip code 467-0001
Address Kawasumi 1, Mizuho-cho, Mizuho-ku, Nagoya-city, Aichi
TEL 0528538093
Email shinkei@med.nagoya-cu.ac.jp

Public contact
Name of contact person
1st name Shoji
Middle name
Last name Kawashima
Organization Nagoya City University
Division name Department of neurology
Zip code 467-0001
Address Kawasumi 1, Mizuho-cho, Mizuho-ku, Nagoya-city, Aichi
TEL 0528538093
Homepage URL
Email shoji@med.nagoya-cu.ac.jp

Sponsor
Institute Nagoya City University
Institute
Department

Funding Source
Organization Grants-in-Aid for Scientific Research on Priority Areas
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor none
Name of secondary funder(s)

IRB Contact (For public release)
Organization Institutional Review Board of the Nagoya City University
Address Kawasumi 1, Mizuho-cho, Mizuho-ku, Nagoya-city, Aichi
Tel 0528587215
Email clinical_research@med.nagoya-cu.ac.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 名古屋市立大学病院(愛知県)

Other administrative information
Date of disclosure of the study information
2021 Year 11 Month 21 Day

Related information
URL releasing protocol https://kaken.nii.ac.jp/report/KAKENHI-PROJECT-15K16362/15K16362seika/
Publication of results Partially published

Result
URL related to results and publications https://kaken.nii.ac.jp/report/KAKENHI-PROJECT-15K16362/15K16362seika/
Number of participants that the trial has enrolled 12
Results On comparisons between PD-MCI and PD-CN, the correct answer of the 2-back test was worse in PD-MCI, and fMRI findings revealed activations within the middle frontal gyrus and inferior parietal lobule during 2-back test were reduced. In the results of cross-over study for PD-MCI, there were no regions enhanced by memantine. However, exploring regions reduced by memantine, we found the reduced activations within lingual gyrus and superior frontal gyrus. Correct answers of 2-back test was worse on memantine.
Results date posted
2021 Year 11 Month 17 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
2021 Year 09 Month 03 Day
Baseline Characteristics We enrolled 28 patients with PD and 12 age-matched healthy controls (HC). Thirteen patients were classified as MCI (PD-MCI), and 15 as cognitively normal PD (PD-CN).
Participant flow In 12 patients with PD-MCI who agreed the cross-over study, two patients withdrew during study period. Hence, the population in this study constitutes the 10 patients who completed follow-up.
Adverse events Daytime sleepiness
Outcome measures Using functional MRI (fMRI), we explored the specific brain regions associated with the visuospatial n-back test in the PD-MCI, PD-CN, and HC groups. In next step, we investigate whether memantine can alter brain function of the patients with PD-MCI, using fMRI. We explored the brain regions associated with visuospatial working memory, and searched the differences in behavioral performance and neuroimaging findings between memantine intervention and placebo.
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2012 Year 10 Month 31 Day
Date of IRB
2013 Year 01 Month 08 Day
Anticipated trial start date
2013 Year 03 Month 01 Day
Last follow-up date
2016 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2021 Year 11 Month 17 Day
Last modified on
2021 Year 11 Month 17 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033525

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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