UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000031649 |
|---|---|
| Receipt number | R000036138 |
| Scientific Title | Effectiveness of whey peptide and ripening extract of hop for Japanese patients of mild Alzheimer's disease-prospective double-blind study (Kirin Alzheimer's Disease Project; KIRINAD) |
| Date of disclosure of the study information | 2018/03/09 |
| Last modified on | 2019/06/10 12:29:13 |
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Basic information
Public title
Effectiveness of whey peptide and ripening extract of hop for Japanese patients of mild Alzheimer's disease
Acronym
(Kirin Alzheimer's Disease Project; KIRINAD)
Scientific Title
Effectiveness of whey peptide and ripening extract of hop for Japanese patients of mild Alzheimer's disease-prospective double-blind study (Kirin Alzheimer's Disease Project; KIRINAD)
Scientific Title:Acronym
(Kirin Alzheimer's Disease Project; KIRINAD)
Region
| Japan |
Condition
Condition
Patients with mild Alzheimer's disease
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Investigation of tolerance and effectiveness of ripening extract of hop and whey peptide containing high concentration of dipeptide (Trp-Tyr) for Japanese patients with mild Alzheimer's disease.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Estimating for effectiveness of ripening extract of hop and whey peptide containing high concentration of dipeptide (Trp-Tyr) for Japanese patients with mild Alzheimer's disease.
0W (Before); general blood test (including peripheral inflammation markers and phenotype of ApoE), psychological assessments (ADAS-Jcog, MMSE, POMS2)
12W; general blood test (including peripheral inflammation markers and phenotype of ApoE), psychological assessments (ADAS-Jcog, MMSE, POMS2) and SPECT
24W; general blood test (including peripheral inflammation markers and phenotype of ApoE), psychological assessments (ADAS-Jcog, MMSE, POMS2)
36W; general blood test (including peripheral inflammation markers and phenotype of ApoE), psychological assessments (ADAS-Jcog, MMSE, POMS2)
Key secondary outcomes
Measurement of the frequencies for tolerance of ripening extract of hop (bitter taste) and whey peptide containing high concentration of dipeptide (Trp-Tyr) (abdominal bloating) for Japanese at 12W, 24W and 36W.
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
Ripening extract of hop tablets (70mg/day) , 3 month
Interventions/Control_2
Whey peptide (dipeptide; Trp-Tyr) Tablets (1g/day), 3 month
Interventions/Control_3
placebo (maltodextrin) tablets (1g/day), 3 month
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Meeting the clinical criteria for Alzheimer's disease according to NINCDS-ADRDA, and features of brain MRI examination and brain blood flow of Single photon emission computed tomography (SPECT)
Key exclusion criteria
Patients with milk allergy (whey)
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Tohru |
| Middle name | |
| Last name | Ohnuma |
Organization
Juntendo University Hospital
Division name
Department of Psychiatry
Zip code
113-8431
Address
3-1-3 Hongo, Bunkyo-ku, Tokyo
TEL
03-5802-1071
otoru@juntendo.ac.jp
Public contact
Name of contact person
| 1st name | Tohru |
| Middle name | |
| Last name | Ohnuma |
Organization
Juntendo University
Division name
Department of Psychiatry
Zip code
113-8421
Address
2-1-1 Hongo, Bunkyo-ku, Tokyo
TEL
03-5802-1071
Homepage URL
otoru@juntendo.ac.jp
Sponsor or person
Institute
Department of Psychiatry, Juntendo University, Faculty of Medicine
Institute
Department
Personal name
Funding Source
Organization
KIRIN Company
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
Juntendo Hospital Certified Review Board
Address
3-1-3,Hongo,Bunkyo-ku,Tokyo 113-8431
Tel
03-5802-1584
crbjun@juntendo.ac.jp
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
| 2018 | Year | 03 | Month | 09 | 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
| 2018 | Year | 02 | Month | 23 | Day |
Date of IRB
| 2018 | Year | 02 | Month | 23 | Day |
Anticipated trial start date
| 2018 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2020 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2018 | Year | 03 | Month | 09 | Day |
Last modified on
| 2019 | Year | 06 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036138
