UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000026013 |
|---|---|
| Receipt number | R000029832 |
| Scientific Title | Efficacy of memantine in patients with moderate-to-severe Alzheimer's disease: results of pooled analysis, using realistic definitions of response, of two randomized, double-blind, placebo-controlled trials in Japan |
| Date of disclosure of the study information | 2017/02/06 |
| Last modified on | 2018/03/08 23:15:43 |
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Basic information
Public title
Efficacy of memantine in patients with moderate-to-severe Alzheimer's disease: results of pooled analysis, using realistic definitions of response, of two randomized, double-blind, placebo-controlled trials in Japan
Acronym
A pooled analysis of efficacy of memantine in patients with moderate-to-severe Alzheimer's disease (MEM-DS-15019)
Scientific Title
Efficacy of memantine in patients with moderate-to-severe Alzheimer's disease: results of pooled analysis, using realistic definitions of response, of two randomized, double-blind, placebo-controlled trials in Japan
Scientific Title:Acronym
A pooled analysis of efficacy of memantine in patients with moderate-to-severe Alzheimer's disease (MEM-DS-15019)
Region
| Japan |
Condition
Condition
Alzheimer's disease
Classification by specialty
| Neurology | Geriatrics | Psychiatry |
| Neurosurgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the efficacy of memantine in Japanese patients with moderate-to-severe Alzheimer's disease from the viewpoint of realistic definitions of response.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Proportion of patients showing clinical worsening in individual domains, and in combined multiple domains.
Domains are as follows:
- SIB-J (cognition)
- CIBIC plus-J (Global ststus)
- FAST (Function)
- Behave-AD (BPSD)
Key secondary outcomes
Base
Study type
Others,meta-analysis etc
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
Patients with moderate to severe AD who participated in a late phase II study and a phase III study, and were treated with either memantine at 20 mg/day or placebo.
Key exclusion criteria
Patients who did not have a result of efficacy assessment at the start of the study
Target sample size
633
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yasunori Tawaragi |
Organization
Daiichi Sankyo Co., LTD.
Division name
Medical Science Department
Zip code
Address
Medical Science Department
TEL
03-6225-1053
tawaragi.yasunori.sp@daiichisankyo.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Daiju Matsui |
Organization
Daiichi Sankyo Co., LTD.
Division name
Oncology & Pain Group, Medical Science Department
Zip code
Address
3-5-1, Nihonbashi-honcho, Chuo-ku, Tokyo 103-8426, Japan
TEL
03-6225-1046
Homepage URL
matsui.daiju.ks@daiichisankyo.co.jp
Sponsor or person
Institute
Daiichi Sankyo Co., LTD.
Institute
Department
Personal name
Funding Source
Organization
Daiichi Sankyo Co., LTD.
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
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 02 | Month | 06 | Day |
Related information
URL releasing protocol
Publication of results
Published
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
Main results already published
Date of protocol fixation
| 2017 | Year | 02 | Month | 03 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 02 | Month | 06 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Expert Opin Pharmacother. 2018 Mar 6:1-6. doi: 10.1080/14656566.2018.1442440. [Epub ahead of print]
https://www.tandfonline.com/doi/full/10.1080/14656566.2018.1442440
Management information
Registered date
| 2017 | Year | 02 | Month | 06 | Day |
Last modified on
| 2018 | Year | 03 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029832
