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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000016420
Receipt No. R000019065
Scientific Title 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
Date of disclosure of the study information 2015/02/03
Last modified on 2017/11/02

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Basic information
Public title 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
Acronym An exploratpry study of the effects of memantine with the evaluation on cognition/BPSD and FDG-PET/SPECT in moderate AD patient
Scientific Title 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
Scientific Title:Acronym 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
1st name
Middle name
Last name Kumiko Utsumi
Organization Sunagawa City Medical Center
Division name the department of psychiatry
Zip code
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
1st name
Middle name
Last name Tadahiro Hashida
Organization Micron Inc.
Division name Clinical Research Department
Zip code
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)

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 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

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
2015 Year 01 Month 05 Day
Date of IRB
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

Other
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

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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