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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000009958
Receipt No. 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

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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
Email 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
Email atakeda@nishitaga.hosp.go.jp

Sponsor
Institute National Hospital Organization, Sendai-Nishitaga Hospital
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011661

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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