UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037421 |
|---|---|
| Receipt number | R000042538 |
| Scientific Title | An open-labeled single arm study on improvement of cognitive function by istradefylline for parkinson disease |
| Date of disclosure of the study information | 2019/08/01 |
| Last modified on | 2023/07/23 11:25:41 |
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Basic information
Public title
A study on improvement of cognitive function by istradefylline for parkinson disease
Acronym
A study on improvement of cognitive function by istradefylline for parkinson disease
Scientific Title
An open-labeled single arm study on improvement of cognitive function by istradefylline for parkinson disease
Scientific Title:Acronym
A study on improvement of cognitive function by istradefylline for parkinson disease
Region
| Japan |
Condition
Condition
Parkinson disease
Classification by specialty
| Neurology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To validate whether istradefylline improves cognitive function of Parkinson disease.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Primary outcome is digit span test, arithmetic test, verval fluency test, Standard verbal paired-associate learning test, Benton visual retention test. These tests will be evaluated 12weeks later after starting treatment.
Key secondary outcomes
Secondary outcomes are Movement Disorder Society-Unified Parkinson Disease Rating Scale(MDS-UPDRS),mini-mental state examination(MMSE), Non-motor symptoms scales and freezing of gait of questionnaire(FOG-Q).
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Prescription istradefylline 20 mg for 1 month. If there are no side effects, We increase to 40 mg and prescribe for 2 months.
The assessments will be made in all patients participating the study, patients with MMSE scores of 26 or more, patients with MMSE score of less than 26.
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
| 40 | years-old | <= |
Age-upper limit
| 85 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1. The patients meet clinically established or clinically probable cases of clinical diagnostic criteria of Parkinson disease by Movement Disorder Society
2. The item of Attention/memory in NMSS is 1 or more.
3. The patient is treated with drugs that include L-dopa
4. The age of patients is 40 to 85years old.
5. Written consent has been obtained.
Key exclusion criteria
1. Mini mental state examination (MMSE) is 20 points or less.
2. Istradefylline has been prescribed
Target sample size
25
Research contact person
Name of lead principal investigator
| 1st name | Masahiro |
| Middle name | |
| Last name | Kanai |
Organization
Ichinomiya Nishi Hospital
Division name
Neurology
Zip code
494-0001
Address
1, Kaimei-hira, Ichinomiya-city, Aichi, 494-0001, Japan
TEL
0586480077
masabilliard35@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Masahiro |
| Middle name | |
| Last name | Kanai |
Organization
Ichinomiya Nishi Hospital
Division name
Neurology
Zip code
494-0001
Address
1, Kaimei-hira, Ichinomiya-city, Aichi
TEL
0586480077
Homepage URL
masabilliard35@yahoo.co.jp
Sponsor or person
Institute
Ichinomiya Nishi Hospital
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ichinomiya Nishi Hospital
Address
1, Kaimei-hira, Ichinomiya-city, Aichi
Tel
0586480077
matsubara@anzu.or.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
| 2019 | Year | 08 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
14
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2019 | Year | 02 | Month | 01 | Day |
Date of IRB
| 2019 | Year | 02 | Month | 15 | Day |
Anticipated trial start date
| 2019 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2021 | Year | 08 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2019 | Year | 07 | Month | 18 | Day |
Last modified on
| 2023 | Year | 07 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042538
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
