UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000023178 |
|---|---|
| Receipt number | R000026717 |
| Scientific Title | Olfactory training for cognitive function in Parkinson's disease - single center clinical trial |
| Date of disclosure of the study information | 2016/08/01 |
| Last modified on | 2024/03/08 22:15:21 |
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Basic information
Public title
Olfactory training for cognitive function in Parkinson's disease - single center clinical trial
Acronym
Olfactory training for congnition in PD
Scientific Title
Olfactory training for cognitive function in Parkinson's disease - single center clinical trial
Scientific Title:Acronym
Olfactory training for cognitive function in Parkinson's disease - single center clinical trial
Region
| Japan |
Condition
Condition
Parkinson's disease
Classification by specialty
| Neurology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this investigation is whether olfactory training will improve congnitive function of patients with PD.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The rate of change in Japanese version of Montreal congnitive Assessment(MOCA-J) between first week and 12weeks.
Key secondary outcomes
1)Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS),The Odor Stick Identification Test for the Japanese (OSIT-J), MMSE, Beck Depression Inventory (BDI), Parkinson's Disease Questionnaire-39 (PDQ-39),T&T olfactometry.These rates of change between first week and 12weeks.
2)Duration until stopping the study due to change of anti-Parkinsonian medications
3)Otorhinolaryngology examination
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
olfactory traning
Interventions/Control_2
control
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1)Patients with Parkinson's disease; MDS clinical diagnostic criteria for Parkinson's disease
2)No change in Anti-parkinsonian medications over 4 weeks
3)Lower than Modified Hoehn and Yahr stage 4
4)Mini Mental State Examination over 20, lower than 26
5)Inpatients or outpatients
6)Living with their caregivers
7)Age over 19, both women and men
8)Agreed with signed consent form
Key exclusion criteria
1)dementia or person who cannot understand the way of olfactory training
2)Patients with Parkinsonism
3)Modified Hoehn & Yahr stage 5
4)abnormal olfactory function based on ENT problem, or sever cardiac, pulmonary, liver, gastrointestinal disease.
5)patients with carcinoma
6)pregnancy
7)allergy
8)person who are considered to be inappropriate.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Nobutaka |
| Middle name | |
| Last name | Hattori |
Organization
Juntendo University School of Medicine
Division name
Department of Neurology
Zip code
1130033
Address
2-1-1 Hongo, Bunkyo-ku, Tokyo, Japan 113-0033
TEL
03-3813-3111
nhattori@juntendo.ac.jp
Public contact
Name of contact person
| 1st name | Mayuko |
| Middle name | |
| Last name | Ogawa |
Organization
Juntendo University School of Medicine
Division name
Department of Neurology
Zip code
1130033
Address
2-1-1 Hongo, Bunkyo-ku, Tokyo, Japan 113-0033
TEL
03-3813-3111
Homepage URL
maogawa@juntendo.ac.jp
Sponsor or person
Institute
Juntendo University School of Medicine, Department of Neurology
Institute
Department
Personal name
Funding Source
Organization
self funding
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
SENDAI NISHITAGA NATIONAL HOSPITAL
T.Hasegawa CO.,LTD
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Research Ethics Committee Faculty of Medicine, Juntendo University
Address
3-1-3,Hongo Bunkyo-ku,Tokyo,JAPAN
Tel
03-3813-3111
hongo-rinri@juntendo.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
順天堂大学医学部付属順天堂医院
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 08 | Month | 01 | Day |
Related information
URL releasing protocol
NA
Publication of results
Unpublished
Result
URL related to results and publications
NA
Number of participants that the trial has enrolled
5
Results
This study was suspended.
Results date posted
| 2024 | Year | 03 | Month | 08 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Parkinson's disease patiens.
Male3,Female2.Avarage age 72 years old.
Participant flow
Olfactory training with fragrance was conducted for 3 months. Baseline, midterm, and post-termination evaluations were conducted.
Adverse events
Nothing.
Outcome measures
Primary endpoints
1)The rate of change in Japanese version of Montreal congnitive Assessment(MOCA-J) between first week and 12weeks.
Secondary endpoints
1)Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS),The Odor Stick Identification Test for the Japanese (OSIT-J), MMSE, Beck Depression Inventory (BDI), Parkinson's Disease Questionnaire-39 (PDQ-39),T&T olfactometry.These rates of change between first week and 12weeks.
2)Duration until stopping the study due to change of anti-Parkinsonian medications
3)Otorhinolaryngology examination
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Terminated
Date of protocol fixation
| 2016 | Year | 06 | Month | 24 | Day |
Date of IRB
| 2018 | Year | 06 | Month | 22 | Day |
Anticipated trial start date
| 2019 | Year | 04 | Month | 18 | Day |
Last follow-up date
| 2022 | 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
| 2016 | Year | 07 | Month | 14 | Day |
Last modified on
| 2024 | Year | 03 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026717
