UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Effects of donepezil on the prognosis of Parkinson's disease with severe olfactory dysfunction
Title of the study (Brief title)	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	Atsushi Takeda
Organization	National Hospital Organization, Sendai-Nishitaga Hospital
Division name	Department of Neurology
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	Atsushi Takeda
Organization	National Hospital Organization, Sendai-Nishitaga Hospital
Division name	Department of Neurology
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2012 Year 09 Month 25 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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/icdr_e/ctr_view.cgi?recptno=R000011661