UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	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
Title of the study (Brief title)	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	Yasunori Tawaragi
Organization	Daiichi Sankyo Co., LTD.
Division name	Medical Science Department
Address	Medical Science Department
TEL	03-6225-1053
Email	tawaragi.yasunori.sp@daiichisankyo.co.jp

Public contact
Name of contact person	Daiju Matsui
Organization	Daiichi Sankyo Co., LTD.
Division name	Oncology & Pain Group, Medical Science Department
Address	3-5-1, Nihonbashi-honcho, Chuo-ku, Tokyo 103-8426, Japan
TEL	03-6225-1046
Homepage URL
Email	matsui.daiju.ks@daiichisankyo.co.jp

Sponsor
Institute	Daiichi Sankyo Co., LTD.
Institute
Department

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)

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

Progress
Recruitment status	Main results already published
Date of protocol fixation	2017 Year 02 Month 03 Day
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

Related information
URL releasing protocol
Publication of results	Published
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029832