UMIN-CTR Clinical Trial

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

Dementia of the Alzheimer type

Classification by specialty

Psychiatry

Classification by malignancy

Others

Genomic information

NO

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

Primary outcomes

To evaluate performance of the object recognition behavior task and the paired-associate learning task

Key secondary outcomes

Study type

Interventional

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Double blind -all involved are blinded

Control

Placebo

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

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

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

Institute

Kyoto University Graduate School of Medicine

Institute

Department

Personal name

Organization

Strategic Research Program for Brain Science

Organization

Division

Category of Funding Organization

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

京都大学医学部附属病院

Date of disclosure of the study information

2014

Year

09

Month

10

Day

URL releasing protocol

Publication of results

Unpublished

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

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 related information

Registered date

2014

Year

09

Month

10

Day

Last modified on

2015

Year

03

Month

30

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017568