UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Effects of Kihito on cognitive functions in Alzheimer's disease patients
Title of the study (Brief title)	Effects of Kihito on cognitive functions in Alzheimer's disease patients
Region	Japan

Condition
Condition	Alzheimer's disease
Classification by specialty	Neurology Psychosomatic Internal Medicine Geriatrics Psychiatry
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Investigation of cognitive functions at pre and post (16 weeks after) administration of Kampo medicine, Kihito.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase	Not applicable

Assessment
Primary outcomes	At the pre and post (for 16 weeks) administration of kKihito, these tests of cognitive functions are done; Mini Mental State Examination (MMSE)and Repeatable Battery for the Assessment (RBANS).
Key secondary outcomes	analysis of the blood

Base
Study type	Interventional

Study design
Basic design	Cross-over
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Active
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	Treatment
Type of intervention	Medicine
Interventions/Control_1	Only Cholinesterase inhibitor (aricept, for 16 weeks - Cholinesterase inhibitor plus Kihito for 16 weeks *without washout period *Tsumura Kihito (2.5 g in package; 3 packages/day)
Interventions/Control_2	Cholinesterase inhibitor plus Kihito for 16 weeks - Only Cholinesterase inhibitor (aricept, for 16 weeks *without washout period *Tsumura Kihito (2.5 g in package; 3 packages/day)
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	100 years-old >=
Gender	Male and Female
Key inclusion criteria	Adults living in Toyama prefecture, who was diagnosed as Alzheimer's disease by cognitive testa and image analyses, and has taken any cholinesterase inhibitor more than 6 months. Score of MMSE in the person is above 15 points.
Key exclusion criteria	Persons whose MMSE score is below 14 points.
Target sample size	24

Research contact person
Name of lead principal investigator	Chihiro Tohda
Organization	University of Toyama
Division name	Division of Neuromedical Science, Institute of Natural Medicine
Address	2630 Sugitani, Toyama, 930-0194, JAPAN
TEL	076-434-7646
Email	chihiro@inm.u-toyama.ac.jp

Public contact
Name of contact person	Chihiro Tohda
Organization	University of Toyama
Division name	Division of Neuromedical Science, Institute of Natural Medicine
Address	2630 Sugitani, Toyama, 930-0194, JAPAN
TEL	076-434-7646
Homepage URL
Email	chihiro@inm.u-toyama.ac.jp

Sponsor
Institute	University of Toyama
Institute
Department

Funding Source
Organization	University of Toyama
Organization
Division
Category of Funding Organization	Other
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	国立大学法人　富山大学

Other administrative information
Date of disclosure of the study information	2016 Year 08 Month 22 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 03 Month 07 Day
Anticipated trial start date	2016 Year 08 Month 22 Day
Last follow-up date	2018 Year 03 Month 31 Day
Date of closure to data entry	2018 Year 09 Month 30 Day
Date trial data considered complete	2018 Year 12 Month 31 Day
Date analysis concluded	2019 Year 03 Month 31 Day

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2016 Year 08 Month 05 Day
Last modified on	2018 Year 09 Month 18 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027079