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Assessment of neuroinflammation and immune function for predicting the onset and improving the prognosis of dementia

Assessment of neuroinflammation and immune function for predicting the onset and improving the prognosis of dementia - AIM-Brain study

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000059945
Enrollment
80
Registered
2025-12-08
Start date
2025-12-08
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Older and younger adults with dementia and those with mild cognitive impairment, Individuals with normal cognitive function

Interventions

Activated-astrocyte PET imaging ([18F]SMBT-1-PET), Tau PET ([18F]Florzolotau-PET)

Sponsors

National Center for Geriatrics and Gerontology
Lead Sponsor
National Center of Neurology and Psychiatry
Collaborator

Eligibility

Sex/Gender
All

Inclusion criteria

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.

Exclusion criteria

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.

Design outcomes

Primary

MeasureTime frame
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.

Secondary

MeasureTime frame
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.

Countries

Japan

Contacts

Public ContactYasuyuki Kimura

National Center for Geriatrics and Gerontology Department of Clinical and Experimental Neuroimaging

yazkim@ncgg.go.jp0562-46-2311

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026