UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Study in the effect of Citrus Reticulata peels on the cognitive function in the patients with Alzheimer Disease
Title of the study (Brief title)	Study in the effect of Citrus Reticulata peels on the cognitive function in the patients with Alzheimer Disease
Region	Japan

Condition
Condition	Alzheimer Disease
Classification by specialty	Neurology Geriatrics
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	study on the effect of Citrus Reticulata peels on the cognitive impairment
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	ADAS-cog MMSE
Key secondary outcomes	NPI Barthel Index

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -but assessor(s) are blinded
Control	Active
Stratification	NO
Dynamic allocation	YES
Institution consideration	Institution is considered as adjustment factor in dynamic allocation.
Blocking	YES
Concealment	Central registration

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	ordinary treatment, rehabilitation with oral administration of Citrus Reticulata peels
Interventions/Control_2	ordinary treatment and rehabilitation
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

Eligibility
Age-lower limit	60 years-old <=
Age-upper limit	99 years-old >=
Gender	Male and Female
Key inclusion criteria	Alzheimer Disease MMSE score between 13 and 25
Key exclusion criteria	other dementia or mental disease MMSE score under 13 and over 25
Target sample size	80

Research contact person
Name of lead principal investigator	Takashi SEKI
Organization	Tohoku University Graduate School of Medicine
Division name	Department of Geriatric Behavioral Neurology
Address	2-1 seiryo-machi, Aoba-ku, Sendai, Miyagi, JAPAN
TEL	+81-22-717-7359
Email	t-seki@m.tohoku.ac.jp

Public contact
Name of contact person	Takashi SEKI
Organization	Tohoku University Graduate School of Medicine
Division name	Department of Geriatric Behavioral Neurology
Address	2-1 seiryo-machi, Aoba-ku, Sendai, Miyagi, JAPAN
TEL	+81-22-717-7359
Homepage URL
Email	t-seki@m.tohoku.ac.jp

Sponsor
Institute	Tohoku University Graduate School of Medicine
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one.

Funding Source
Organization	Grant in Aid of the laboratory
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

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	大崎市田尻診療所(宮城県）、国立病院機構米沢病院(山形県）、東京医科歯科大学医学部附属病院（東京都）、 近畿大学医学部附属病院（大阪府）

Other administrative information
Date of disclosure of the study information	2010 Year 06 Month 24 Day

Progress
Recruitment status	No longer recruiting
Date of protocol fixation	2010 Year 06 Month 24 Day
Anticipated trial start date	2010 Year 06 Month 01 Day
Last follow-up date
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	2010 Year 06 Month 24 Day
Last modified on	2016 Year 06 Month 24 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000004603