UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	An exploratpry study of the correlation of effects of memantine for cognitive function/BPSD and functional alterations on image of FDG-PET/SPECT in moderate Alzheimer's disease patient
Title of the study (Brief title)	An exploratpry study of the effects of memantine with the evaluation on cognition/BPSD and FDG-PET/SPECT in moderate AD patient
Region	Japan

Condition
Condition	Moderate Alzheimer's Disease
Classification by specialty	Neurology Geriatrics Psychiatry Radiology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To explore the effects on FDG-PET and SPECT with the patients who are treated with memantine as a first choice for moderate Alzheimer's disease
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	FDG-PET, SPECT, MMSE and NPI after 12 weeks
Key secondary outcomes	- FDG-PET, SPECT, MMSE and NPI after 52 weeks - Safety information

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Memantine FDG-PET and SPECT scans at the visit of screening, 12 weeks, 52 weeks
Interventions/Control_2
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	50 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1) Patients who have signed the informed consent form 2) Are <= 50 years of age 3) Japanese, regardless of sex 4) Fulfills both of the criteria below - Alzheimer's disease according to DSM-5 - All-cause dementias and probable AD dementia according to NIA-AA criteria 5) Patient whose CT/MRI and SPECT within 1 month prior to signing informed consent results show as AD 6) Screening MMSE score of 14 to 19 7) Untreated AD patient before enrolled in this study ...etc.
Key exclusion criteria	1) Dementia other than AD 2) Significant neurologic desease 3) Other muscloskeletal complication which may affects implementing cognitive assessments 4) Significant psychiatric disorder 5) History of alcoholism or drug addiction 6) History of severe drug allegy 7) Other clinically important or uncontrolled diseases at the time of screening 8) Use of investigational medications within 60 days prior to screening etc.
Target sample size	30

Research contact person
Name of lead principal investigator	Kumiko Utsumi
Organization	Sunagawa City Medical Center
Division name	the department of psychiatry
Address	3-1-1, Nishi-yonjo-kita, Sunagawa city, Hokkaido
TEL	0125-54-2131
Email	utsumimomo@s9.dion.ne.jp

Public contact
Name of contact person	Tadahiro Hashida
Organization	Micron Inc.
Division name	Clinical Research Department
Address	3-8-1, Marunouchi, Chiyoda-ku, Tokyo
TEL	03-6268-0305
Homepage URL
Email	hashida@micron-kobe.com

Sponsor
Institute	Sunagawa City Medical Center
Institute
Department

Funding Source
Organization	Daiichi-Sankyo Company, Limited
Organization
Division
Category of Funding Organization	Profit organization
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	砂川市立病院（北海道）

Other administrative information
Date of disclosure of the study information	2015 Year 02 Month 03 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 01 Month 05 Day
Anticipated trial start date	2015 Year 04 Month 10 Day
Last follow-up date	2017 Year 09 Month 12 Day
Date of closure to data entry	2017 Year 09 Month 29 Day
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	2015 Year 02 Month 02 Day
Last modified on	2017 Year 11 Month 02 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019065