UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016420 |
|---|---|
| Receipt number | 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 12:57:08 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
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
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
hashida@micron-kobe.com
Sponsor or person
Institute
Sunagawa City Medical Center
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019065
