UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000059945 |
|---|---|
| Receipt number | R000068561 |
| Scientific Title | Assessment of neuroinflammation and immune function for predicting the onset and improving the prognosis of dementia |
| Date of disclosure of the study information | 2025/12/08 |
| Last modified on | 2025/12/02 15:00:14 |
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Basic information
Public title
Assessment of neuroinflammation and immune function for predicting the onset and improving the prognosis of dementia
Acronym
AIM-Brain study
Scientific Title
Assessment of neuroinflammation and immune function for predicting the onset and improving the prognosis of dementia
Scientific Title:Acronym
AIM-Brain study
Region
| Japan |
Condition
Condition
Older and younger adults with dementia and those with mild cognitive impairment, Individuals with normal cognitive function
Classification by specialty
| Neurology | Geriatrics | Psychiatry |
| Radiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to clarify how neuroinflammation and immune function influence the onset, clinical manifestations, and prognosis of dementia, including Alzheimer's disease, a condition whose risk increases with aging. By elucidating these mechanisms, the study seeks to promote the development of new therapeutic strategies targeting brain inflammation and immune function.
Basic objectives2
Others
Basic objectives -Others
Assessment of disease pathology
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
To clarify the relationship between cognitive function and blood biomarkers reflecting neuroinflammation and immune function in late-onset dementia.
To clarify the relationship between cognitive function and blood biomarkers reflecting neuroinflammation and immune function in early-onset dementia.
Key secondary outcomes
To elucidate the relationship between activated-astrocyte PET imaging and blood biomarkers reflecting neuroinflammation and immune function.
To elucidate the association between regional astrocyte activation and cognitive function in late-onset dementia.
To elucidate the association between regional astrocyte activation and microglial density or amyloid pathology.
To elucidate the association between regional astrocyte activation and cognitive function in early-onset dementia.
To elucidate the association between regional astrocyte activation and tau pathology.
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Diagnosis
Type of intervention
| Medicine |
Interventions/Control_1
Activated-astrocyte PET imaging ([18F]SMBT-1-PET), Tau PET ([18F]Florzolotau-PET)
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
| 40 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Participants with late-onset dementia (including moderate stages) and those with mild cognitive impairment
1. Individuals who have provided written informed consent, either by themselves or through a family member (legal representative).
2. Individuals accompanied by a study partner who can observe and evaluate the participant's condition, and for whom written consent from the study partner has also been obtained.
3. Men and women diagnosed with dementia or mild cognitive impairment, with age at onset of 65 years or older.
4. Individuals who have agreed to the storage of biological samples in the NCGG Biobank.
2) Participants with early-onset dementia (including moderate stages) and those with mild cognitive impairment
1. Individuals who have provided written informed consent, either by themselves or through a family member (legal representative).
2. Individuals accompanied by a study partner who can observe and evaluate the participant's condition, and for whom written consent from the study partner has also been obtained.
3. Men and women diagnosed with dementia or mild cognitive impairment, with age at onset younger than 65 years.
4. Individuals who have agreed to the storage of biological samples in the NCNP Biobank.
3) Cognitively normal participants
1. Individuals who voluntarily apply for participation and provide written informed consent.
2. Men and women aged 40 years or older at the time of consent.
3. Individuals with an MMSE score of 24 or higher.
4. Individuals who meet the following WMS-R Logical Memory II criteria:
Score >= 9 for those with >=16 years of education
Score >= 5 for those with 10-15 years of education
Score >= 3 for those with 0-9 years of education
5. Individuals who agree to the storage of biological samples in the Biobank.
Key exclusion criteria
1) Exclusion criteria applicable to all participants
1. Individuals judged by the principal investigator or study physicians to be at a higher-than-usual risk of health injury due to participation in this study.
2. Individuals deemed unable to undergo the study examinations.
3. Individuals with severe comorbidities, or a history of such conditions, for whom the principal investigator or study physicians consider participation inappropriate.
4. Individuals who regularly take steroidal or non-steroidal anti-inflammatory drugs, or immunosuppressive agents.
5. Individuals who are unable to remain still during examinations (applicable only when PET imaging is performed).
6. Individuals with ferromagnetic implants or materials in the body (including tattoos and permanent makeup, pacemakers, etc.) (applicable only when MRI is performed).
7. Individuals with severe claustrophobia (applicable only when MRI is performed).
8. Individuals with a history of drug allergy (applicable only when PET imaging is performed).
9. Pregnant or possibly pregnant women, and breastfeeding women (applicable only when PET imaging is performed).
10. Any other individuals deemed unsuitable for participation by the principal investigator or study physicians.
Exclusion criteria by participant category
1) Cognitively normal participants
1. Individuals with developmental or psychiatric conditions that may interfere with study examinations.
2. Individuals who have undergone nuclear medicine examinations within six months prior to obtaining consent, due to radiation exposure considerations.
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | Yasuyuki |
| Middle name | |
| Last name | Kimura |
Organization
National Center for Geriatrics and Gerontology
Division name
Department of Clinical and Experimental Neuroimaging
Zip code
474-8511
Address
7-430 Morioka-cho, Obu, Aichi
TEL
0562-46-2311
yazkim@ncgg.go.jp
Public contact
Name of contact person
| 1st name | Yasuyuki |
| Middle name | |
| Last name | Kimura |
Organization
National Center for Geriatrics and Gerontology
Division name
Department of Clinical and Experimental Neuroimaging
Zip code
474-8511
Address
7-430 Morioka-cho, Obu, Aichi
TEL
0562-46-2311
Homepage URL
yazkim@ncgg.go.jp
Sponsor or person
Institute
National Center for Geriatrics and Gerontology
Institute
Department
Personal name
Funding Source
Organization
Japan Health Research Promotion Bureau
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
National Center of Neurology and Psychiatry
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics and Conflict of Interest Committee, National Center for Geriatrics and Gerontology
Address
7-430 Morioka-cho, Obu, Aichi
Tel
0562-46-2311
yaday@ncgg.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
国立長寿医療研究センター（愛知県）、国立精神・神経医療研究センター（東京都）
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 12 | Month | 08 | 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
Preinitiation
Date of protocol fixation
| 2025 | Year | 09 | Month | 29 | Day |
Date of IRB
| 2025 | Year | 09 | Month | 29 | Day |
Anticipated trial start date
| 2025 | Year | 12 | Month | 08 | Day |
Last follow-up date
| 2029 | Year | 03 | 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
| 2025 | Year | 12 | Month | 02 | Day |
Last modified on
| 2025 | Year | 12 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068561
