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Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000014319
Receipt No. R000016671
Official scientific title of the study The effect of the transdermal acetylcholine esterase inhibitors on frontal lobe function in Alzhemer's disease patients
Date of disclosure of the study information 2014/06/19
Last modified on 2015/05/27

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Basic information
Official scientific title of the study The effect of the transdermal acetylcholine esterase inhibitors on frontal lobe function in Alzhemer's disease patients
Title of the study (Brief title) The effect of the transdermal acetylcholine esterase inhibitors on frontal lobe function
Region
Japan

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

Objectives
Narrative objectives1 This study will demonstrate the effectiveness of the transdermal acetylcoline esterase inhibitors on the impainment of frontal lobe function in Alzheimer's disease paitients neuropsychological test
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes CPT test and memory updating test (part of CAT)
Key secondary outcomes

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

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 The transdermal acetylcholine esteras inhibitors
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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

Eligibility
Age-lower limit
60 years-old <=
Age-upper limit
89 years-old >=
Gender Male and Female
Key inclusion criteria Patients who are diagnosed mild to moderate Alzheimer's disease(MMSE10-23 and CDR 0.5-2)
Naive patients for AD treatments patients swithching from donepezil/galatamine(requiring wash out for 4weeks),if necessary.
Male and female AD patients basically outpatients,how ever inpatients can be included if necessary
Key exclusion criteria Severa AD patients(MMSE<10)
Target sample size 50

Research contact person
Name of lead principal investigator Masaru Mimura
Organization Keio University
Division name Department of Neuropsychiatry
Address 35 Shinanomachi shinjyuku-ku Tokyo 160-8582 Japan
TEL 0353633829
Email mimura@a7.keio.jp

Public contact
Name of contact person Hajime tabuchi
Organization Keio University
Division name Department of Neuropsychiatry
Address 35 Shinanomachi shinjyuku-ku Tokyo 160-8582 Japan
TEL 0353633829
Homepage URL
Email tabuchi@a8.keio.jp

Sponsor
Institute Keio University
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and
report of the research including funding management. It doesn't mean
funding agency". Therefore, all clinical trial should have the one.

Funding Source
Organization Novartis fharma,INC.
Organization
Division
Category of Funding Organization
Nationality of Funding Organization

Other related organizations
Co-sponsor The Salvation Army Booth Mental Hospital
Tsutsuji-Mental Hospital
Ashikari clinic
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
2014 Year 06 Month 19 Day

Progress
Recruitment status Open public recruiting
Date of protocol fixation
2013 Year 11 Month 12 Day
Anticipated trial start date
2014 Year 01 Month 01 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 Unpublished
URL releasing results
Results
Other related information

Management information
Registered date
2014 Year 06 Month 19 Day
Last modified on
2015 Year 05 Month 27 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016671


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