UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000010852 |
|---|---|
| Receipt number | R000012692 |
| Scientific Title | Usefulness of 11PiB PET/CT in patients with dementia |
| Date of disclosure of the study information | 2013/06/10 |
| Last modified on | 2015/06/01 10:04:09 |
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Basic information
Public title
Usefulness of 11PiB PET/CT in patients with dementia
Acronym
Usefulness of 11PiB PET/CT
Scientific Title
Usefulness of 11PiB PET/CT in patients with dementia
Scientific Title:Acronym
Usefulness of 11PiB PET/CT
Region
| Japan |
Condition
Condition
Dementia
Classification by specialty
| Neurology | Geriatrics | Psychiatry |
| Radiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate clinical impact of PET on patients with dementia in a single institute and to clarify diagnostic usefulness of PET based on NIA AA criteria in clinical situation
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
NIA-AA criteria (2011)
Key secondary outcomes
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 | Device,equipment |
Interventions/Control_1
11C PIB PET/CT
Maximum times of 11C PiB PET: 4 times
Observation period: at least for 6 months after PET examinations
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
1.Patients with memory disturbance or cognitive impairment decided by dementia specialist
2.MMSE score of over 10
3.Adult
Key exclusion criteria
1. Bed ridden persons
2. Persons with severe impairment of visual acuity and/or auditory sensor
3. Persons with past history of severe head injury
4. Persons with delirium due to abuse of alcohol or drugs.
5. Expecting mother at PET examination
6. Persons with contraindications of MRI, SPECT, and PET
7. Inadequate persons decided by medical doctors
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kimiteru Ito |
Organization
Tokyo Metropolitan Geriatric Hospital
Division name
Department of Radiology
Zip code
Address
35-2 Sakae-cho Itabashi-ku Tokyo
TEL
03-3964-1141
kimiteru-ito@tmghig.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hiroshi Matsuda |
Organization
National center of neurology and Psychiatry
Division name
Integrative Brain Imaging Center
Zip code
Address
4-1-1 ogawahigashi-cho Kodaira Tokyo
TEL
042-341-2711
Homepage URL
matsudah@ncnp.go.jp
Sponsor or person
Institute
National center of neurology and Psychiatry
Institute
Department
Personal name
Funding Source
Organization
Japan society of the promotion of science
Organization
Division
Category of Funding Organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
国立精神神経医療研究センター病院
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 06 | Month | 10 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
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
Completed
Date of protocol fixation
| 2011 | Year | 09 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 10 | Month | 13 | Day |
Last follow-up date
| 2015 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2015 | Year | 04 | Month | 30 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2013 | Year | 06 | Month | 01 | Day |
Last modified on
| 2015 | Year | 06 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012692
