UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000021965 |
|---|---|
| Receipt number | R000025322 |
| Scientific Title | Prospective observational study on relationship between plasma-free amino acids profiles and risk of mild cognitive impairment, including future risk of Alzheimer's disease onset |
| Date of disclosure of the study information | 2016/04/29 |
| Last modified on | 2023/10/23 21:18:05 |
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Basic information
Public title
Prospective observational study on relationship between plasma-free amino acids profiles and risk of mild cognitive impairment, including future risk of Alzheimer's disease onset
Acronym
Observational study on plasma-free amino acids profiles in mild cognitive impairment (MCI) cohort
Scientific Title
Prospective observational study on relationship between plasma-free amino acids profiles and risk of mild cognitive impairment, including future risk of Alzheimer's disease onset
Scientific Title:Acronym
Observational study on plasma-free amino acids profiles in mild cognitive impairment (MCI) cohort
Region
| Japan |
Condition
Condition
Mild Cognitive Impairment (MCI), Alzheimer's disease (AD)
Classification by specialty
| Neurology | Geriatrics | Psychiatry |
| Adult |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
To examine the benefit of plasma-free amino acid profiles as a tool for differentiation of mild cognitive impairment (MCI) from cognitively normal subjects, and future high-risk MCI subjects who will convert to Alzheimer's disease from low-risk ones.
Basic objectives2
Others
Basic objectives -Others
Plasma-free amino acids and related metabolites (without intervention)
Trial characteristics_1
Others
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Plasma-free amino acids and related metabolites
Key secondary outcomes
Results of neuropsychological tests
Results of diagnostic imaging
Onset of Alzheimer's disease
APOE4 allele
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Not be 'probable AD' with NINCDS-ADRDA (The National Institute od Neurologic, Communicatibve Disorders and Stroke AD and Related disorders Association) criteria.
MMSE (Mini Mental State Examination) score is between 24 to 30 points.
(Additional entry criteria for MCI subjects are described below.)
WMS-R LMII (Wechsler Memory Scale-Revised Logical Memory) score is less than 11, 9, or 6 points (with schooling history for more than 16 years, 8-15 years, 0-7 years, respectively).Or score of CDR(Clinical Dementia Rating) is 0.5.
Score of GDS-J (Geriatric Depression Scale-Japanese version) is less than 6 points.
Possible to obtain agreement of participation in the trial from subject himself/herself or legal representative.
Key exclusion criteria
Subjects who have taken any amino acid-formulations, supplements, and bevarage within 10 hours before the blood collection.
Subjects who have taken meals within 10 hours before the blood collection.
Subjects who have been educated for less than 6 years.
Subjects who have previous history or are under medical treatment for alcohol addiction.
Patients of cancer or cirrhosis of liver.
Dialysis patients
Subjects who developed other neurodegenerative or mental disorders.
In addition to above, subjects who are judged as ineligible by the medical doctors who are responsible for this trial as investigators.
Target sample size
600
Research contact person
Name of lead principal investigator
| 1st name | Takeshi |
| Middle name | |
| Last name | Ikeuchi |
Organization
Niigata University
Division name
Brain Research Institute
Zip code
951-8510
Address
1-757 Asahimachi, Chuo-ku, Niigata 951-8585, JAPAN
TEL
+81-25-227-2344
ikeuchi@bri.niigata-u.ac.jp
Public contact
Name of contact person
| 1st name | Hitomi |
| Middle name | |
| Last name | Kitamura |
Organization
Ajinomoto Co., Inc.
Division name
Aminoindex&Supportive Care Group, Research Institute For Biosciences&Fine Chemicals
Zip code
210-8681
Address
1-1 Suzuki-cho, Kawasaki-ku, Kawasaki 210-8681, JAPAN
TEL
+81-44-210-5835
Homepage URL
hitomi.kitamura01.mx9@asv.ajinomoto.com
Sponsor or person
Institute
Niigata University
Institute
Department
Personal name
Funding Source
Organization
Japan society for the promotion of science
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Ajinomoto Co., Inc.
Name of secondary funder(s)
Ajinomoto Co., Inc.
IRB Contact (For public release)
Organization
Niigata University Internal Review Board
Address
1-757, Asahimachi-dori, Chouo-ku, Niigata city, Japan
Tel
+81-25-227-0912
msasaki@med.niigata-u.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
新潟大学医歯学総合病院（新潟県）、国立病院機構西新潟中央病院（新潟県）、リハビリテーションセンター・みどり病院（新潟県）、旭川圭泉会病院（北海道）、新渡戸記念中野総合病院（東京都）、福井大学医学部（福井県）、くるみクリニック（東京都）、甲府脳神経外科病院（山梨県）、砂川市立病院（北海道）、足利大学看護学部（栃木県）、東京都健康長寿医療センター研究所（東京都）、東京医科歯科大学（東京都）、昭和大学（東京都）、三島病院（新潟県）、味の素株式会社健康推進センター、かわしま神経内科クリニック（神奈川県）、高槻病院（大阪府）、南東北医療クリニック（福島県）
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 04 | Month | 29 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
Result
URL related to results and publications
https://doi.org/10.3390/nu14030637
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
No longer recruiting
Date of protocol fixation
| 2016 | Year | 03 | Month | 04 | Day |
Date of IRB
| 2014 | Year | 07 | Month | 10 | Day |
Anticipated trial start date
| 2016 | Year | 04 | Month | 29 | Day |
Last follow-up date
| 2026 | Year | 02 | Month | 24 | Day |
Date of closure to data entry
| 2026 | Year | 02 | Month | 24 | Day |
Date trial data considered complete
| 2026 | Year | 02 | Month | 24 | Day |
Date analysis concluded
| 2026 | Year | 02 | Month | 24 | Day |
Other
Other related information
Subjects who meet the entry criteria and agree with participation among visitors to clinical sites in this trial from April 2016 to the end of March 2023 will be included in this trial. The onset status of dementia (including Alzheimer's disease) of the subjects will be followed for 3 years (for subjects of mild cognitive impairment) after blood collection and measurement of plasma-free amino acids at the baseline.
Management information
Registered date
| 2016 | Year | 04 | Month | 18 | Day |
Last modified on
| 2023 | Year | 10 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025322
