UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000024911 |
|---|---|
| Receipt number | R000028658 |
| Scientific Title | Efficiency of 5-aminolevulinic acid for amnestic mild cognitive impairment and early Alzheimer disease. Confirmatory randomized controlled trial |
| Date of disclosure of the study information | 2016/11/21 |
| Last modified on | 2016/11/20 10:09:21 |
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Basic information
Public title
Efficiency of 5-aminolevulinic acid for amnestic mild cognitive impairment and early Alzheimer disease. Confirmatory randomized controlled trial
Acronym
Efficiency of 5-aminolevulinic acid for amnestic mild cognitive impairment and early Alzheimer disease. Confirmatory randomized controlled trial
Scientific Title
Efficiency of 5-aminolevulinic acid for amnestic mild cognitive impairment and early Alzheimer disease. Confirmatory randomized controlled trial
Scientific Title:Acronym
Efficiency of 5-aminolevulinic acid for amnestic mild cognitive impairment and early Alzheimer disease. Confirmatory randomized controlled trial
Region
| Japan |
Condition
Condition
Amnestic mild cognitive impairment and early Alzheimer disease
Classification by specialty
| Neurology | Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To efficiency of 5-aminolevulinic acid in inhibiting progression of cognitive dysfunction for amnestic mild cognitive impairment and early Alzheimer disease.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The alteration of MMSE (mini mental state examination) and CDR (clinical dementia rating Japan)
Key secondary outcomes
The alteration of WMS-R (Wecheler Memory Scale -reviced)logical memory II and ADAS-Jcog (Alzheimer disease assessment scale-Japan)
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is considered as a block.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
Daily oral administration of 5-ALA 100mg, each 50mg after breakfast and before bedtime, for 52 weeks.
Interventions/Control_2
Placebo
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
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1)Alzheimer disease
(NINDCS-ADRDA criteria)
2)MMSE score 20-24 point
3)FAST score 3-4
4)Patients can consent by a document
Key exclusion criteria
1)Severe BPSD(behavioral and psychological symptom of dementia)
2)Severe auditory disorder
3)Poor general condition
4)Complication of adequate pharmaceutical management by patients or caregiver
5)Patients with contraindication of MRI (Magnetic resonance imaging)
6)Patients who cannot join this study
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Noriyuki Matsukawa |
Organization
Nagoya City University Hospital
Division name
Department of Neurology
Zip code
Address
1 Kawasummi, Mizoho-cho, Mizuho-ku
TEL
052-851-5511
norim@med.nagoya-cu.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Noriyuki Matsukawa |
Organization
Nagoya City University
Division name
Department of Neurology
Zip code
Address
1 Kawasummi, Mizoho-cho, Mizuho-ku
TEL
052-851-5511
Homepage URL
norim@med.nagoya-cu.ac.jp
Sponsor or person
Institute
Nagoya City University
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
Fukushimura hospital
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
| 2016 | Year | 11 | Month | 21 | 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
Enrolling by invitation
Date of protocol fixation
| 2016 | Year | 09 | Month | 30 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 11 | Month | 21 | 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
| 2016 | Year | 11 | Month | 19 | Day |
Last modified on
| 2016 | Year | 11 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028658
