UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000031649
Receipt No. 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

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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
Email 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
Email otoru@juntendo.ac.jp

Sponsor
Institute Department of Psychiatry, Juntendo University, Faculty of Medicine
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036138

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.