UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000036908 |
|---|---|
| Receipt number | R000042060 |
| Scientific Title | A dementia study by 11C-PiB, 18F-FDG PET |
| Date of disclosure of the study information | 2019/05/31 |
| Last modified on | 2025/02/28 16:06:26 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
A dementia study by 11C-PiB, 18F-FDG PET
Acronym
A dementia study by 11C-PiB, 18F-FDG PET
Scientific Title
A dementia study by 11C-PiB, 18F-FDG PET
Scientific Title:Acronym
A dementia study by 11C-PiB, 18F-FDG PET
Region
| Japan |
Condition
Condition
mild cognitive impairment, Alzheimer's disease, dementia with Lewy bodies, cerebrovascular dementia, frontotemporal degeneration, progressive supranuclear palsy, corticobasal degeneration, Parkinson's disease with dementia, other neurodegenerative diseases, normal pressure hydrocephalus, hypoxic encephalopathy, brain tumor, brain injury etc.
Classification by specialty
| Neurology | Geriatrics | Psychiatry |
| Neurosurgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose is to clarify the condition of dementia by 11C-PiB, 18F-FDG PET evaluating changes in brain lesions over time in dementia and the relationship between brain lesions and cognitive functions.
Basic objectives2
Others
Basic objectives -Others
pathophysiology
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Differences in glucose metabolism , degree of accumulation of amyloid, accumulation site of amyloid by disease
Key secondary outcomes
Relationship between clinical features and glucose metabolism, degree and site of amyloid accumulation
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
Prevention
Type of intervention
| Device,equipment |
Interventions/Control_1
11C-PiB, 18F-FDG 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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Persons who were visited to our hospital and diagnosed with dementia or mild cognitive impairment and given an agreement on the PET study
Key exclusion criteria
1. Persons with other serious illnesses or unstable conditions,
2. Persons suffering from deformities / disorders of spine or hip with pain in resting position,
3. Persons judged inappropriate by doctor or the chief researcher
Target sample size
150
Research contact person
Name of lead principal investigator
| 1st name | Toshihisa |
| Middle name | |
| Last name | Tajima |
Organization
Nagoya City Rehabilitation Agency
Division name
Bureau of Planning and Research
Zip code
4678622
Address
1-2 Mikanyama, Yatomi-cho, Mizuho-ku, Nagoya, Japan
TEL
052-835-3811
ttajimat@gmail.com
Public contact
Name of contact person
| 1st name | Toshihisa |
| Middle name | |
| Last name | Tajima |
Organization
Nagoya City Rehabilitation Agency
Division name
Bureau of Planning and Research
Zip code
4678622
Address
1-2 Mikanyama, Yatomi-cho, Mizuho-ku, Nagoya, Japan
TEL
052-835-3811
Homepage URL
ttajimat@gmail.com
Sponsor or person
Institute
Nagoya City Rehabilitation Agency
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Nagoya City Rehabilitation Agency
Address
1-2 Mikanyama, Yatomi-cho, Mizuho-ku, Nagoya, Japan
Tel
052-835-3811
soumubu@nagoya-rehab.or.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
名古屋市総合リハビリテーション事業団(愛知県)
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 05 | 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
161
Results
The number of patients with negative findings on PET scan that changed the clinical diagnosis: PiB 30 (18.6%), FDG 9 (6.0%)
The number of patients with PET scan findings supportive and consistent with the clinical diagnosis was 112 (69.6%) for PiB and 60 (39.7%) for FDG.
The number of cases with atypical or abnormal findings on PET scan and no findings supporting or contradicting the clinical diagnosis was 19 (11.8%) for PiB and 82 (54.3%) for FDG.
Results date posted
| 2025 | Year | 02 | Month | 28 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
72 males, 89 females, ages 41 to 91 years
Ligand and dose 11C-PiB 437 to 579 MBq/person or 18F-FDG 158 to 194 MBq/person
Number of patients tested by disease
PiB Alzheimer's disease 64 cases, Vascular dementia 8 cases, Frontotemporal dementia 14 cases, Lewy body dementia 3 cases, Mild cognitive impairment 48 cases, Others 24 cases
FDG Alzheimer's disease 61 cases, Vascular dementia 7 cases, Frontotemporal dementia 11 cases, Lewy body dementia 2 cases, Mild cognitive impairment 47 cases, Others 23 cases
Participant flow
Number of subjects included in the study 161 cases
Number of PiB subjects 161
Number of FDG subjects 151
Adverse events
none
Outcome measures
The number of patients with negative findings on PET scan that changed the clinical diagnosis: PiB 30 (18.6%), FDG 9 (6.0%)
The number of patients with PET scan findings supportive and consistent with the clinical diagnosis was 112 (69.6%) for PiB and 60 (39.7%) for FDG.
The number of cases with atypical or abnormal findings on PET scan and no findings supporting or contradicting the clinical diagnosis was 19 (11.8%) for PiB and 82 (54.3%) for FDG.
In dementia-related diseases, PiB significantly changed the clinical diagnosis more often than FDG (p<0.001).
By disease, the clinical diagnosis was changed in 14 (21.9%) Alzheimer's disease PiB, 2 (3.3%) FDG, 4 (8.3%) mild cognitive impairment PiB, 0 (0%) FDG, and significantly more cases with PiB, whereas the PET findings were neither negative nor supportive and had little effect on the diagnosis Alzheimer's disease PiB 0 (0%) FDG 21 (34.4%), mild cognitive impairment PiB 3 (6.3%) FDG 39 (83.0%) were significantly more common with FDG (Alzheimer's disease p<0.001, mild cognitive impairment p<0.001). No significant differences were found for other dementia-related diseases. No significant differences were found for other dementia-related diseases.
Of the 64 patients diagnosed with Alzheimer's disease, 14 (21.9%) were PiB negative, and of the 48 patients diagnosed with MCI, 16 (66.7%) were PiB positive.
Among dementia patients with aphasia as the main symptom, 3 of 7 (42.9%) patients with primary progressive aphasia, 1 of 2 (50.0%) patients with semantic aphasia, and 7 of 7 (100%) patients with logopenic progressive aphasia were PiB-positive.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2019 | Year | 05 | Month | 20 | Day |
Date of IRB
| 2019 | Year | 05 | Month | 29 | Day |
Anticipated trial start date
| 2019 | Year | 05 | Month | 31 | Day |
Last follow-up date
| 2024 | Year | 11 | Month | 13 | Day |
Date of closure to data entry
| 2024 | Year | 11 | Month | 13 | Day |
Date trial data considered complete
| 2024 | Year | 11 | Month | 13 | Day |
Date analysis concluded
| 2024 | Year | 11 | Month | 13 | Day |
Other
Other related information
Management information
Registered date
| 2019 | Year | 05 | Month | 31 | Day |
Last modified on
| 2025 | Year | 02 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042060
