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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000013591
Receipt No. R000015880
Scientific Title Open-labeled prospective clinical trial of Axona(R) in the treatment of mild to moderate Alzheimer's disease.
Date of disclosure of the study information 2014/05/01
Last modified on 2015/11/01

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Basic information
Public title Open-labeled prospective clinical trial of Axona(R) in the treatment of mild to moderate Alzheimer's disease.
Acronym Clinical trial of Axona(R) for Alzheimer's disease.
Scientific Title Open-labeled prospective clinical trial of Axona(R) in the treatment of mild to moderate Alzheimer's disease.
Scientific Title:Acronym Clinical trial of Axona(R) for Alzheimer's disease.
Region
Japan

Condition
Condition mild to moderate Alzheimer's disease.
Classification by specialty
Psychiatry
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Investigation of safety and efficacy in use of Axona(R).
1) Investigation for the frequency of occurrence for intolerance (e.g. diarrhea) by taking Axona(R) in Japanese subjects.
2) Investigation for the efficacy of Axona(R) in mild to moderate Japanese patients with Alzheimer's disease.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Intolerance scale, blood test (incl. ketone body and HbA1c), cognitive battery test (ADAS-Jcog, MMSE)
Key secondary outcomes

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
Food
Interventions/Control_1 Patients taking Axona(R).
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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Patients diagnosed as mild to moderate Alzheimer's disease (MMSE10~26).
Key exclusion criteria 1) Patients already showing severe diarrhea.
2) Patients with severe state of diabetes and ketoasidosis.
Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Heii Arai
Organization Juntendo University Faculty of Medicine
Division name Department of Psychiatry
Zip code
Address 2-1-1 Hongo, Bunkyo-ku, Tokyo 113-8421
TEL 03-3813-3111
Email mental@juntendo.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Tohru Ohnuma
Organization Juntendo University Faculty of Medicine
Division name Department of Psychiatry
Zip code
Address 2-1-1 Hongo, Bunkyo-ku, Tokyo 113-8421
TEL 03-3813-3111
Homepage URL
Email otoru@juntendo.ac.jp

Sponsor
Institute Dept. of Psychiatry, Juntendo University Faculty of Medicine
Institute
Department

Funding Source
Organization Nestle Japan
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
2014 Year 05 Month 01 Day

Related information
URL releasing protocol
Publication of results Partially published

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results We found that Japanese patients with AD could be treated with Axona; without severe intolerance and gastrointestinal side effects. The modified dose titration method, starting with a low dose of Axona (10 mg, containing 5 mg of caprylic acid-8) reduced the adverse effects (such as diarrhea) in Japanese patients. It was not possible to demonstrate clearly any cognitive benefits of Axona in a trial with limited patient numbers. Further studies with a large number of patients, focusing on mild AD Japanese patients, should be performed to assess the effects of Axona in detail.
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 02 Month 13 Day
Date of IRB
Anticipated trial start date
2014 Year 03 Month 28 Day
Last follow-up date
2015 Year 04 Month 30 Day
Date of closure to data entry
2015 Year 04 Month 30 Day
Date trial data considered complete
2015 Year 04 Month 30 Day
Date analysis concluded
2015 Year 05 Month 31 Day

Other
Other related information

Management information
Registered date
2014 Year 04 Month 01 Day
Last modified on
2015 Year 11 Month 01 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015880

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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