UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000052657 |
|---|---|
| Receipt number | R000059662 |
| Scientific Title | Correlation of amyloid and melanin in Alzheimer's disease |
| Date of disclosure of the study information | 2023/10/31 |
| Last modified on | 2024/10/31 11:40:24 |
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Basic information
Public title
Correlation of amyloid and melanin in Alzheimer's disease
Acronym
Analysis of amyloid and melanin
Scientific Title
Correlation of amyloid and melanin in Alzheimer's disease
Scientific Title:Acronym
Correlation of amyloid and melanin in Alzheimer's disease
Region
| Japan |
Condition
Condition
Mild cognitive impairment
Alzheimer's disease
Healthy older adults
Classification by specialty
| Neurology | Geriatrics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate whether assessment of melanin concentration in the locus coeruleus is useful for screening before amyloid PET scan using 11C-PiB with suspected Alzheimer's disease.
Basic objectives2
Others
Basic objectives -Others
Correlations between quantitative assessment of cerebral amyloid and melanin in the locus ceruleus
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Correlations between quantitative assessment of cerebral amyloid and melanin in the locus ceruleus
Key secondary outcomes
Diagnostic accuracy of qualitative and quantitative assessment of melanin in the locus ceruleus using Standard of Truth (SOT) for quantitative assessment of amyloid
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
| 60 | years-old | <= |
Age-upper limit
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
･Alzheimer disease (AD) patients (mild AD, mild cognitive impairment)
Common parts
1) Age of ranging from 60 to 80 years, regardless of gender
2) Being outpatient of the dementia center of our hospital
3) Patients having the ability to provide informed consent
A. Mild AD
a) Diagnosed as probable AD based on NIA-AA (National Institute on Aging and Alzheimer's Association) or DSM-5 (Diagnostic and Statistical Manual of Mental Disorders)
b) MMSE 20-23
c) Clinical Dementia Scale (CDR) global score 0.5 or 1
B. Mild cognitive impairment due to AD
a) Diagnosed as MCI due to AD based on NIA-AA or DSM-5
b) MMSE 24-27
c) CDR global score 0.5 and memory domain 0.5
･Healthy controls
1) Age of ranging from 60 to 80 years, regardless of gender
2) Normal cognition (MMSE 28 or more and CDR global score 0 and normal range by years of education in delayed recall of the Wechsler Memory Scale-Revised : 9 or higher for 16 years of education, 5 or higher for 10-15 years, and 3 or higher for 0-9 years)
3) Patients having the ability to provide informed consent
Key exclusion criteria
1) Patients diagnosed with a dementia other than AD
2) Subjects with possible Dementia with Lewy Bodies (DLB)
･MDS-UPDRS part 3 of 10 or more
･an abnormality in the neurological examination
･history of parkinsonism in first-degree relatives
･the Beck Depression Inventory ver,2 score of 12 or more
･Who has a possibility of a rapid eye movement sleep behavior disorder (RBD) evaluated by the RBD screening questionnaire
･abnormal MIBG scintigraphy or [123I]FP-CIT SPECT, either in the past or during the study period
3) having abnormalities (e.g.brain tumors, cerebrovascular malformations, cortical infarcts) in MRI
4) who has a cardiac pacemaker, metals in the body, tattoo, and claustrophobia
5) have suffered from major depression or bipolar disorder within the past year, or have a history of schizophrenia in the past
6) subjects judged by the principle investigator not to be eligible
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Yoko |
| Middle name | |
| Last name | Shigemoto |
Organization
National Center of Neurology and Psychiatry Hospital
Division name
Department of Radiology
Zip code
187-8551
Address
4-1-1, Ogawa-Higashi, Kodaira, Tokyo, Japan
TEL
042-341-2712
yokos@ncnp.go.jp
Public contact
Name of contact person
| 1st name | Yoko |
| Middle name | |
| Last name | Shigemoto |
Organization
National Center of Neurology and Psychiatry Hospital
Division name
Department of Radiology
Zip code
187-8551
Address
4-1-1, Ogawa-Higashi, Kodaira, Tokyo, Japan
TEL
042-341-2712
Homepage URL
yokos@ncnp.go.jp
Sponsor or person
Institute
National Center of Neurology and Psychiatry Hospital
Institute
Department
Personal name
Funding Source
Organization
Grants-in-Aid for Scientific Research
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
National Center of Neurology and Psychiatry Hospital
Address
4-1-1, Ogawa-Higashi, Kodaira, Tokyo, Japan
Tel
042-341-2712
yokos@ncnp.go.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
| 2023 | Year | 10 | Month | 31 | 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
| Delay expected |
Results Delay Reason
Due to the decrease in patient recruitment into clinical studies with the approval of Recanemab
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
Open public recruiting
Date of protocol fixation
| 2023 | Year | 09 | Month | 10 | Day |
Date of IRB
| 2023 | Year | 09 | Month | 20 | Day |
Anticipated trial start date
| 2023 | Year | 09 | Month | 20 | Day |
Last follow-up date
| 2026 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
observational study
Management information
Registered date
| 2023 | Year | 10 | Month | 31 | Day |
Last modified on
| 2024 | Year | 10 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000059662
