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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000024911
Receipt No. 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

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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
Email 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
Email norim@med.nagoya-cu.ac.jp

Sponsor
Institute Nagoya City University
Institute
Department

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
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

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028658

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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