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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000014581
Receipt No. R000016963
Scientific Title A clinical study for patients with moderate to severe Alzheimer's disease using Memantine hydrochloride OD tablet.
Date of disclosure of the study information 2014/07/22
Last modified on 2015/05/13

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Basic information
Public title A clinical study for patients with moderate to severe Alzheimer's disease using Memantine hydrochloride OD tablet.
Acronym A clinical study for patients with moderate to severe Alzheimer's disease using Memantine hydrochloride OD tablet.
Scientific Title A clinical study for patients with moderate to severe Alzheimer's disease using Memantine hydrochloride OD tablet.
Scientific Title:Acronym A clinical study for patients with moderate to severe Alzheimer's disease using Memantine hydrochloride OD tablet.
Region
Japan

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

Objectives
Narrative objectives1 To examine improvement of medication adherence, effect of burden reduction and easy to take for caregivers about moderate to severe Alzheimer's patient who are taking Memantine hydrochloride OD tablet.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Evaluation of functionality
Key secondary outcomes Evaluation of safety

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Switching from Memantine hydrochloride tablet 20mg to Memantine hydrochloride OD tablet 20mg

Intervention period of 4 weeks
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
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1.Patients who are diagnosed as moderate to severe Alzheimer's disease by investigator
2.Patients who have taken Memantine hydrochloride tablet 20mg for 4 weeks before evaluation period
3.Patients who are 20 years or over
4.Patients who are able to understand this study and give informed consent in literature by patient and a caregiver or families
Key exclusion criteria 1.Dementia patients except Alzheimer's disease
2.Patients who have severe mental disorder
3.Patients who are pregnant or trying to get pregnant, or during breastfeeding
4.Patients with a history of the hypersensitivity for Memantine hydrochloride tablets
5.The case that a investigator judged to be inappropriate
Target sample size 60

Research contact person
Last name of lead principal investigator
1st name
Middle name
Last name Mutsuo Enomoto
Organization Enomoto naika clinic
Division name Medicine, Geriatrics and Neurology
Zip code
Address 2-12-9,Tobitakyu Chofu-City,Tokyo,Japan
TEL 042-444-0456
Email info@enomoto-naika-clinic.com

Public contact
1st name of contact person
1st name
Middle name
Last name Hiroki Kato
Organization Sogo Rinsho Medefi Company Limited
Division name Business Promotion Department
Zip code
Address 3-2-7,Nishishinjuku
TEL 03-6901-6079
Homepage URL
Email kato.hiroki@sogo-medefi.jp

Sponsor
Institute Enomoto naika clinic
Institute
Department

Funding Source
Organization Daiichi Sankyo Company, Limited
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 榎本内科クリニック

Other administrative information
Date of disclosure of the study information
2014 Year 07 Month 22 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 Completed
Date of protocol fixation
2014 Year 07 Month 04 Day
Date of IRB
Anticipated trial start date
2014 Year 08 Month 22 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
2014 Year 07 Month 17 Day
Last modified on
2015 Year 05 Month 13 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016963

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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