UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057200 |
|---|---|
| Receipt number | R000065384 |
| Scientific Title | Observational study on the characteristics of clinical and brain imaging findings and the risk of dementia. |
| Date of disclosure of the study information | 2025/03/04 |
| Last modified on | 2025/03/04 10:56:51 |
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Basic information
Public title
Observational study of the characteristics of clinical and brain imaging findings, including cognitive function, and the risk of dementia at memory clinics.
Acronym
Observational study on the characteristics of clinical and brain imaging findings and the risk of dementia.
Scientific Title
Observational study on the characteristics of clinical and brain imaging findings and the risk of dementia.
Scientific Title:Acronym
Observational study on the characteristics of clinical and brain imaging findings and the risk of dementia.
Region
| Japan |
Condition
Condition
dementia
Classification by specialty
| Neurology | Psychiatry |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
The aim of this study is to investigate clinical symptoms, cognitive dysfunction and imaging results in patients with subjective cognitive impairment, mild cognitive impairment and mild dementia from patient medical records to provide a detailed pathological assessment.
Basic objectives2
Others
Basic objectives -Others
An exploratory study of changes over time will be conducted to determine the risk of transition to dementia in patients with subjective cognitive impairment and mild cognitive impairment.
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
1) Clinical symptoms
The following scale is used at the Keio University Hospital Memory Clinic and the outpatient department of neuropsychiatry.
Severity Clinical Dementia Rating
Depression Geriatric Depression Scale
ADL Barthel index
Troublesome Behaviour Scale
Neuropsychiatric Inventory (NPI)
Stroke Scale Hachinski Ischemic Score
Caregiver burden Zarit Caregiver Burden
2) Cognitive function
The neuropsychological tests conducted as screening tests at the Memory Clinic and the Department of Neuropsychiatry at Keio University Hospital are as follows
Brief Dementia Test MMSE and Crock Drawing Test, Cognitive Quotient Test
Generalised Intelligence Raven Colour Progressive Matrix
Memory (Auditory) Rey Auditory Verbal Learning Test
Logical Memory Test
Visual Rey-Osterrieth Complex Figure Test
Attentional functions Trail Making Test
Frontal Lobe Function Revised Stoop Test
Word Fluency Test
3) Brain imaging
MRI data taken at Keio University Hospital in the usual clinical practice will be used.
4) Cerebral blood flow imaging
The results of single photon emission computed tomography (SPECT)
5) Amyloid and tau PET.
PET tests that are covered by insurance or have received marketing authorisation.
6) Blood tests.
Blood tests that are covered by insurance or have marketing authorisation.
7) apoE gene test
APOE genetic test to assess the risk of developing adverse effects when anti-amyloid-beta antibody drugs are introduced.
Key secondary outcomes
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients who visited the Memory Clinic of Keio University Hospital, the Department of Psychiatry and Neurology and the Department of Neurology between January 2008 and 31 May 2035 and underwent head MRI, SPECT, amyloid PET, tau PET, neuropsychological testing, blood test apoE gene testing and clinical symptom assessment during the course of their regular medical care.
In addition to the above, the already completed studies Investigation of the risk of developing Alzheimer disease by FDG-PET and amyloid imaging in patients undergoing physical examination (approval number 20140388) and Alzheimer's disease by FDG-PET in patients undergoing physical examination. Establishment of a pre-onset diagnosis method (approval number 20120099), and Investigation of amyloid imaging in patients with Parkinson's disease (approval number 20140020).
Key exclusion criteria
If a research collaborator expresses a refusal, he or she is excluded from the study.
Target sample size
4000
Research contact person
Name of lead principal investigator
| 1st name | DAISUKE |
| Middle name | |
| Last name | ITO |
Organization
Keio University School of Medicine
Division name
Department of Neurology/Memory center
Zip code
1608582
Address
35 Shinanomachi, Shinjuku-ku,Tokyo 160-8582, Japan
TEL
07048333403
d-ito@jk9.so-net.ne.jp
Public contact
Name of contact person
| 1st name | DAISUKE |
| Middle name | |
| Last name | ITO |
Organization
Keio University School of Medicine
Division name
Department of Neurology/Memory center
Zip code
1608582
Address
35 Shinanomachi, Shinjuku-ku,Tokyo 160-8582, Japan
TEL
07048333403
Homepage URL
https://www.neurology.med.keio.ac.jp/
d-ito@jk9.so-net.ne.jp
Sponsor or person
Institute
Keio University School of Medicine
Institute
Department
Personal name
Daisuke ito
Funding Source
Organization
Keio University School of Medicine
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Keio University School of Medicine Ethics Committee
Address
35 Shinanomachi, Shinjuku-ku,Tokyo 160-8582, Japan
Tel
0333531211
med-rinri@adst.keio.ac.j
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
| 2025 | Year | 03 | Month | 04 | Day |
Related information
URL releasing protocol
https://keio-memory-clinic.com/
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
Open public recruiting
Date of protocol fixation
| 2018 | Year | 02 | Month | 08 | Day |
Date of IRB
| 2018 | Year | 02 | Month | 08 | Day |
Anticipated trial start date
| 2018 | Year | 02 | Month | 08 | Day |
Last follow-up date
| 2035 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
N/A
Management information
Registered date
| 2025 | Year | 03 | Month | 04 | Day |
Last modified on
| 2025 | Year | 03 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065384
