UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000009958 |
|---|---|
| Receipt number | R000011661 |
| Scientific Title | Effects of donepezil on the prognosis of Parkinson's disease with severe olfactory dysfunction |
| Date of disclosure of the study information | 2013/03/01 |
| Last modified on | 2018/08/14 21:25:16 |
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Basic information
Public title
Effects of donepezil on the prognosis of Parkinson's disease with severe olfactory dysfunction
Acronym
Effects of donepezil on the prognosis of Parkinson's disease with severe olfactory dysfunction
Scientific Title
Effects of donepezil on the prognosis of Parkinson's disease with severe olfactory dysfunction
Scientific Title:Acronym
Effects of donepezil on the prognosis of Parkinson's disease with severe olfactory dysfunction
Region
| Japan |
Condition
Condition
Parkinson's disease
Classification by specialty
| Neurology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To assess the effects of donepezil on the risk of Parkinson's disease dementia in Parkinson's disease patients with severe olfactory dysfunction
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Incidence of Parkinson's disease dementia
Key secondary outcomes
- ACE-R
- CDR
- Safety: adverse events, vital signs (blood pressure and pulse rate), laboratory test results, MDS-UPDRS
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
Dynamic allocation
YES
Institution consideration
Institution is considered as adjustment factor in dynamic allocation.
Blocking
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Medicine |
Interventions/Control_1
Donepezil hydrochloride added to standard therapy
Interventions/Control_2
Placebo added to standard therapy
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
| 55 | years-old | <= |
Age-upper limit
| 75 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) Age 55-75 years
2) Patients who developed Parkinson's disease at the age of 40 or older
3) Patients in Hoehn and Yahr stage 1 to 3
4) Patients who are with severe olfactory dysfunction (OSIT-J <=4)
5) Patients who agreed to participate in the study and signed written informed consent (Written informed consent provided by his/her family member is accepted if patients are not capable of giving a written informed consent but orally agreed to participate in the study
Key exclusion criteria
1) Patients with a history of other neurological and/or psychological disorders which may influence motor and cognitive function
2) Patients with the presence of apparent local lesions on head MRI (Note that brain atrophy and white matter ischemia are granted as age-related physiological observation)
3) Patients who had taken anticholinergic drug or drug with an anticholinergic effect within 4 weeks prior to the registration
4) Patients with a symptom such as rhinitis and sinusitis which was considered to affect olfactory sense
5) Patients who need a treatment for depression, the score of >=3 in "1.3. Depressed Mood", the Japanese version of the MDS-UPDRS
6) Patients suspected of impairment in cognitive function (MMSE embedded in the ACE-R <26, or CDR >=1)
7) Patients with a history of hypersensitivity to Donepezil hydrochloride or piperidine derivative
8) Patients with complications of cardiac diseases such as sick sinus syndrome, conduction disturbance in intra-atrial and atrioventricular junction (e.g., sinoatrial block, second- or higher degree atrioventricular block)
9) Patient with a history of severe peptic ulcer
10) Patients with complications of or a history of severe bronchial asthma or obstructive pulmonary disease
11) Patients with a history of stereotaxic surgery or deep brain stimulation
12) Patient who were judged inappropriate for this study by doctors
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Atsushi Takeda |
Organization
National Hospital Organization, Sendai-Nishitaga Hospital
Division name
Department of Neurology
Zip code
Address
2-11-11 Kagitorihoncho, Taihaku-ku, Sendai 982-8555, Japan
TEL
+81-22-245-2111
atakeda@nishitaga.hosp.go.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Atsushi Takeda |
Organization
National Hospital Organization, Sendai-Nishitaga Hospital
Division name
Department of Neurology
Zip code
Address
2-11-11 Kagitorihoncho, Taihaku-ku, Sendai 982-8555, Japan
TEL
+81-22-245-2111
Homepage URL
atakeda@nishitaga.hosp.go.jp
Sponsor or person
Institute
National Hospital Organization, Sendai-Nishitaga Hospital
Institute
Department
Personal name
Funding Source
Organization
Japan Agency for Medical Research and Development (AMED)
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
東北大学（宮城県）/ Tohoku University (Miyagi)
国立病院機構宮城病院（宮城県）/ National Hospital Organization, Miyagi Hospital (Miyagi)
福島県立医科大学（福島県）/ Fukushima Prefectural Medical University (Fukushima)
順天堂大学（東京都）/ Juntendo University (Tokyo)
国立精神神経医療研究センター（東京都）/ National Center of Neurology and Psychiatry (Tokyo)
国立病院機構相模原病院（神奈川県）/ National Hospital Organization, Sagamihara Hospital (Kanagawa)
名古屋大学（愛知県）/ Nagoya University (Aichi)
和歌山県立医科大学（和歌山県）/ Wakayama Medical University (Wakayama)
北海道大学（北海道）/ Hokkaido University (Hokkaido)
秋田大学（秋田県）/ Akita University (Akita)
日本海総合病院（山形県）/ Sakata Medical Center (Yamagata)
竹田綜合病院（福島県）/ Takeda General Hospital (Fukushima)
篠塚病院北関東神経疾患センター（群馬県）/ Kitakanto Neurologic Disorders Research Center (Gunma)
千葉大学（千葉県）/ Chiba University (Chiba)
関東中央病院（東京都）/ Kanto Central Hospital (Tokyo)
東京女子医科大学（東京都）/ Tokyo Women's Medical University (Tokyo)
順天堂大学附属静岡病院（静岡県）/ Juntendo Shizuoka Hospital (Shizuoka)
京都府立医科大学（京都府）/ Kyoto prefectural Medical University (Kyoto)
田附興風会医学研究所北野病院（大阪府）/ Kitano Hospital (Osaka)
岡山旭東病院（岡山県）/ Okayama Kyokuto Hospital (Okayama)
秋田県立脳血管研究センター（秋田県）/ Research Institute for Brain and Blood Vessels Akita (Akita)
国立病院機構仙台西多賀病院（宮城県）/ National Hospital Organization, Sendai-Nishitaga Hospital
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 03 | 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
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
| 2012 | Year | 09 | Month | 25 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 03 | Month | 08 | Day |
Last follow-up date
| 2018 | Year | 04 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2013 | Year | 02 | Month | 05 | Day |
Last modified on
| 2018 | Year | 08 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011661
