UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013591 |
|---|---|
| Receipt number | 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 09:25:56 |
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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
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
otoru@juntendo.ac.jp
Sponsor or person
Institute
Dept. of Psychiatry, Juntendo University Faculty of Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015880
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| Registered date | File name |
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| Registered date | File name |
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