UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000010794 |
|---|---|
| Receipt number | R000012633 |
| Scientific Title | A study on the effect of memantine for psychological symptoms and cerebral blood flow of patients with Alzheimer's disease. |
| Date of disclosure of the study information | 2013/05/25 |
| Last modified on | 2015/06/16 12:01:55 |
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Basic information
Public title
A study on the effect of memantine for psychological symptoms and cerebral blood flow of patients with Alzheimer's disease.
Acronym
Memantine study on Alzheimer's disease
Scientific Title
A study on the effect of memantine for psychological symptoms and cerebral blood flow of patients with Alzheimer's disease.
Scientific Title:Acronym
Memantine study on Alzheimer's disease
Region
| Japan |
Condition
Condition
Alzheimer's disease
Classification by specialty
| Neurology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We will determine the effect on psychological symptoms and cerebral blood flow.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Cognitive function,MRI,SPECT
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Factorial
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
memantine
Interventions/Control_2
memantine and cholinesterase inhibitor
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
| 65 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1)Enrollment at Jikei University Katsushika Medical Center
2)Obtained informed consent
3)Age 65 and more
Key exclusion criteria
History of severe kidney disease
History of renal tubular acidosis or severe urinary tract infection
History of severe liver disease
History of epilepsy
Other difficulties judged by the physician in charge
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shusaku Omoto |
Organization
Katsushika Medical Center, The Jikei University School of Medicine
Division name
Department of Neurology
Zip code
Address
6-41-2 Aoto, Katsushika-ku, Tokyo 125-8506, Japan
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Katsushika Medical Center, The Jikei University School of Medicine
Division name
Department of Neurology
Zip code
Address
TEL
03-3603-2111
Homepage URL
Sponsor or person
Institute
Katsushika Medical Center, The Jikei University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Katsushika Medical Center, The Jikei University School of Medicine
Organization
Division
Category of Funding Organization
Self funding
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
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 05 | Month | 25 | 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
Terminated
Date of protocol fixation
| 2013 | Year | 05 | Month | 23 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 06 | Month | 03 | Day |
Last follow-up date
| 2014 | Year | 11 | Month | 20 | Day |
Date of closure to data entry
| 2014 | Year | 11 | Month | 20 | Day |
Date trial data considered complete
| 2014 | Year | 11 | Month | 20 | Day |
Date analysis concluded
| 2014 | Year | 11 | Month | 20 | Day |
Other
Other related information
Management information
Registered date
| 2013 | Year | 05 | Month | 23 | Day |
Last modified on
| 2015 | Year | 06 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012633
