UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000053175 |
|---|---|
| Receipt number | R000060683 |
| Scientific Title | Observational study of the characteristics of clinical and brain imaging findings, including cognitive function, and the risk of developing dementia in patients seen at memory clinics and neuropsychiatric departments. |
| Date of disclosure of the study information | 2023/12/20 |
| Last modified on | 2023/12/20 13:09:44 |
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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 developing dementia in patients seen at memory clinics and neuropsychiatric departments.
Acronym
Observational study of clinical and brain imaging findings, including cognitive function, in a memory clinic.
Scientific Title
Observational study of the characteristics of clinical and brain imaging findings, including cognitive function, and the risk of developing dementia in patients seen at memory clinics and neuropsychiatric departments.
Scientific Title:Acronym
Observational study of clinical and brain imaging findings, including cognitive function, in a memory clinic.
Region
| Japan |
Condition
Condition
dementia
Classification by specialty
| Neurology | Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study was to investigate clinical symptoms, cognitive impairment 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
Investigating the above changes over time will clarify the risk of transition to dementia in patients with subjective cognitive impairment and mild cognitive impairment.
Trial characteristics_1
Others
Trial characteristics_2
Others
Developmental phase
Assessment
Primary outcomes
Detailed pathological assessment by investigating clinical symptoms, cognitive impairment and imaging results from patient medical records
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, Department of Psychiatry and Neurology, Keio University Hospital
'Investigation of the risk of developing Alzheimer's disease by FDG-PET and amyloid imaging in patients undergoing physical check-ups' (8 cases, Approval No. 20140388), 'Establishment of a method for pre-onset diagnosis of Alzheimer's disease by FDG-PET in patients undergoing physical check-ups' (35 cases, Approval No. 20120099), 'Investigation of amyloid imaging in patients with Parkinson's disease' (14 cases, Approval No. 2014002099). cases, approval number 20120099) and 'Investigation of amyloid imaging in patients with Parkinson's disease' (14 cases, approval number 20140020).
Key exclusion criteria
If the research collaborator expresses a refusal
Target sample size
4000
Research contact person
Name of lead principal investigator
| 1st name | Dasiuke |
| Middle name | |
| Last name | Ito |
Organization
Keio University School of Medicine
Division name
Department of Physiology/Memory center
Zip code
1608582
Address
35 Shinanomachi, Shinjuku-ku,Tokyo 160-8582, Japan
TEL
070-4833-3403
d-ito@jk9.so-net.ne.jp
Public contact
Name of contact person
| 1st name | Dasiuke |
| Middle name | |
| Last name | Ito |
Organization
Keio University School of Medicine
Division name
Department of Physiology/Memory center
Zip code
1608582
Address
35 Shinanomachi, Shinjuku-ku,Tokyo 160-8582, Japan
TEL
070-4833-3403
Homepage URL
https://www.hosp.keio.ac.jp/annai/shinryo/memory/
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
Other
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-jimu@adst.keio.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
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 12 | Month | 20 | 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
Open public recruiting
Date of protocol fixation
| 2008 | Year | 01 | Month | 01 | Day |
Date of IRB
| 2018 | Year | 02 | Month | 08 | Day |
Anticipated trial start date
| 2008 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
| 2025 | Year | 06 | Month | 30 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
Analysis methods include the Statistical Package for the Social Sciences (SPSS) for windows software for the analysis of clinical symptoms and neuropsychological test performance; the Voxel- based Specific Regional Analysis System for Alzheimer's Disease (VSRAD) to assess hippocampal regional atrophy on MRI. NEUROSTAT for analysis of cerebral blood flow images.
Endpoints
(Clinical symptoms)
The following rating scales from the Keio University Hospital Memory Clinic and the outpatient department of neuropsychiatry will be used
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
(Cognitive function)
In the Memory Clinic and Department of Neuropsychiatry at Keio University Hospital, Various neuropsychological tests performed as screening tests
Brain imaging)
MRI data obtained at Keio University Hospital in the usual clinical practice will be used.
(Cerebral blood flow imaging)
(Cerebral Blood Flow Imaging) Single photon emission computed tomography (SPECT) using N-isopropyl-p-[123I]iodoamphetamine (IMP) as tracer, which is commonly used in the Memory Clinic and the Department of Neuropsychiatry at Keio University Hospital. The results of the SPECT test are used.
Management information
Registered date
| 2023 | Year | 12 | Month | 20 | Day |
Last modified on
| 2023 | Year | 12 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000060683
