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Recruitment status Completed
Unique ID issued by UMIN UMIN000015110
Receipt No. R000017568
Scientific Title Study on the effect of improving cognitive function by Betahistine
Date of disclosure of the study information 2014/09/10
Last modified on 2015/03/30

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Basic information
Public title Study on the effect of improving cognitive function by Betahistine
Acronym Study on the effect of improving cognitive function by Betahistine
Scientific Title Study on the effect of improving cognitive function by Betahistine
Scientific Title:Acronym Study on the effect of improving cognitive function by Betahistine
Region
Japan

Condition
Condition Dementia of the Alzheimer type
Classification by specialty
Psychiatry
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To verify the improvement of memory recall impairment by administration of Betahistine
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Explanatory
Developmental phase

Assessment
Primary outcomes To evaluate performance of the object recognition behavior task and the paired-associate learning task
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 Parallel
Randomization Randomized
Randomization unit Individual
Blinding Double blind -all involved are blinded
Control Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 On the first day, subjects receive training of the object recognition behavior task and the paired-associate learning task.
On the 8th day, they take Betahistine and take tests of the object recognition behavior task and the paired-associate learning task.
Then on the 10th day, they take placebo and do them.
Interventions/Control_2 On the first day, subjects receive training of the object recognition behavior task and the paired-associate learning task.
On the 8th day, they take placebo and take tests of the object recognition behavior task and the paired-associate learning task.
Then on the 10th day, they take Betahistine and do them.
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
20 years-old <=
Age-upper limit
50 years-old >
Gender Male and Female
Key inclusion criteria 1) Informed consent for study participants must be obtained from the subjects themselves
2) Over 20 years old and less than 50 years old (at the time of registration)
3) Normal or corrected vision
Key exclusion criteria 1) Active peptic ulcer, bronchial asthma, pheochromocytoma, Meniere's disease, Meniere's syndrome, vertigo, blood disorders, liver failure, kidney failure, and severe mental illness
2) History peptic ulcer, drug dependence, alcoholism, etc.
3) Administration of the drug within a week before the test
4) Pregnant or being suspected females, breast-feeding, males/females who do not agree to the terms of contraception during the study
5) Drinking a fruit juice containing grapefruit, orange, or apple, between the first day and the 8th day in the test period
6) Participated in the Phase 1 clinical trials of new drug substances and received the drug dosing within four months before the test
7) Seropositive of HBs antigen, HCV antibody, HIV antigen-antibody, syphilis serum (TP antibody, RPR method)
8) History of allergies to food or drugs
9) A person who was judged by investigator as an inappropriate subject of the study
Target sample size 43

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name TAKAHASHI Hidehiko
Organization Kyoto University Graduate School of Medicine
Division name Department of Psychiatry
Zip code
Address 54, Shogoin-Kawahara-cho, Sakyo-ku, Kyoto
TEL 075-751-4947
Email hidehiko@kuhp.kyoto-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name MIZUTA Hiroto
Organization Kyoto University Graduate School of Medicine
Division name Department of Psychiatry
Zip code
Address 54, Shogoin-Kawahara-cho, Sakyo-ku, Kyoto
TEL 075-751-4947
Homepage URL
Email hmizuta@kuhp.kyoto-u.ac.jp

Sponsor
Institute Kyoto University Graduate School of Medicine
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 Strategic Research Program for Brain Science
Organization
Division
Category of Funding 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 京都大学医学部附属病院

Other administrative information
Date of disclosure of the study information
2014 Year 09 Month 10 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
2014 Year 07 Month 09 Day
Date of IRB
Anticipated trial start date
2014 Year 09 Month 10 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 09 Month 10 Day
Last modified on
2015 Year 03 Month 30 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017568


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