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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000011392
Receipt No. R000012936
Scientific Title Investigation on efficacy of memantine in patients with Alzheimer's disease.
Date of disclosure of the study information 2013/08/12
Last modified on 2017/11/09

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Basic information
Public title Investigation on efficacy of memantine in patients with Alzheimer's disease.
Acronym Efficacy of memantine in patients with Alzheimer's disease.
Scientific Title Investigation on efficacy of memantine in patients with Alzheimer's disease.
Scientific Title:Acronym Efficacy of memantine in patients with Alzheimer's disease.
Region
Japan

Condition
Condition Alzheimer's disease
Classification by specialty
Neurology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 This study aims to investigate the efficacy of memantine in patients with Alzheimer's disease.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Changes from baseline at week 48 on NPI
Key secondary outcomes Changes from baseline at week 48 on MMSE, TYM-J, Zarit Burden Interview

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 12-month study evaluated the treatment effect and response of memantine in AD patients.
Interventions/Control_2 12-month study evaluated the treatment effect and response of memantine in AD patients.
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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Patients 1) who are Alzheimer's disease, 2) MMSE 0-20, 3) CDR 1-3, FAST stage 2-7, 3) TYM-J 0-34/50, 4) who understand the points of this study and give informed-consent in literature.
Key exclusion criteria 1)Patients who correspond to the administration contraindication o the obhective drug.
2)Patients inadequate for the study.
Target sample size 50

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yumiko Kutoku
Organization Kawasaki Medical School
Division name Neurology
Zip code
Address 577 Matsushima, Kurashiki Okayama 701-0192, Japan
TEL 086-462-1111
Email kutoku@med.kawasaki-m.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yumiko Kutoku
Organization Kawasaki Medical School
Division name neurology
Zip code
Address 577 Matsushima, Kurashiki Okayama 701-0192, Japan
TEL 086-462-1111
Homepage URL
Email kutoku@med.kawasaki-m.ac.jp

Sponsor
Institute Kawasaki Medical School
Institute
Department

Funding Source
Organization Kawasaki Medical School
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
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
2013 Year 08 Month 12 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
2013 Year 08 Month 01 Day
Date of IRB
Anticipated trial start date
2013 Year 08 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2013 Year 08 Month 06 Day
Last modified on
2017 Year 11 Month 09 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012936

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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