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

Email

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


Email

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


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



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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name