UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000009355 |
|---|---|
| Receipt number | R000010988 |
| Scientific Title | Effects of 5-aminolevulinic acid on cognitive functions in normal subjects using fMRI |
| Date of disclosure of the study information | 2012/11/18 |
| Last modified on | 2013/11/19 16:22:11 |
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Basic information
Public title
Effects of 5-aminolevulinic acid on cognitive functions in normal subjects using fMRI
Acronym
Effects of 5-aminolevulinic acid on cognitive functions in normal subjects using fMRI
Scientific Title
Effects of 5-aminolevulinic acid on cognitive functions in normal subjects using fMRI
Scientific Title:Acronym
Effects of 5-aminolevulinic acid on cognitive functions in normal subjects using fMRI
Region
| Japan |
Condition
Condition
healthy adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to investigate the effects of 5-aminolevulinic acid on human cognitive functions.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Comparison of BOLD signal changes measured by fMRI between placebo and 5-aminolevulinic acid conditions.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Blinding
Single blind -participants are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food | Device,equipment |
Interventions/Control_1
1day 1 time 5-aminolevulinic acid 50mg
washout duration 1 week
1day 1 time placebo
Interventions/Control_2
1day 1 time placebo
washout duration 1 week
1day 1 time 5-aminolevulinic acid 50mg
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
| 50 | years-old | <= |
Age-upper limit
| 70 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Healthy adults.
Subjects with no history of psychiatric disorders.
Key exclusion criteria
Subject with history of porphyria, hemochromatosis or viral hepatitis.
Subject with serious disease such as renal, hepatic or cardiac disease.
Subject with photosensitivity.
Subject taking drug within 2 weeks of the trial.
Subject with contraindications to MRI.
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hidenori Suzuki |
Organization
Nippon Medical School, Graduate School of Medicine
Division name
Department of Pharmacology
Zip code
Address
1-1-5, Sendagi, Bunkyo-ku, Tokyo, Japan
TEL
03-3822-2131
hsuzuki@nms.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yumiko Ikeda |
Organization
Nippon Medical School, Graduate School of Medicine
Division name
Department of Pharmacology
Zip code
Address
1-1-5, Sendagi, Bunkyo-ku, Tokyo, Japan
TEL
03-3822-2131
Homepage URL
y-ikeda@nms.ac.jp
Sponsor or person
Institute
Nippon Medical School, Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
SBI Pharmaceuticals Co., Ltd.
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
| 2012 | Year | 11 | Month | 18 | 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
| 2012 | Year | 10 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 11 | Month | 19 | 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
| 2012 | Year | 11 | Month | 18 | Day |
Last modified on
| 2013 | Year | 11 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010988
