UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003419 |
|---|---|
| Receipt number | R000004142 |
| Scientific Title | Study on cardiac sympathetic nerve function in the diagnosis of dementia with Lewy bodies and Alzheimer's disease |
| Date of disclosure of the study information | 2010/04/05 |
| Last modified on | 2013/04/05 22:35:10 |
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Basic information
Public title
Study on cardiac sympathetic nerve function in the diagnosis of dementia with Lewy bodies and Alzheimer's disease
Acronym
Research project of DLB diagnossis
Scientific Title
Study on cardiac sympathetic nerve function in the diagnosis of dementia with Lewy bodies and Alzheimer's disease
Scientific Title:Acronym
Research project of DLB diagnossis
Region
| Japan |
Condition
Condition
Dementia with Lewy bodies
Alzheimer's disease
Classification by specialty
| Neurology | Geriatrics | Psychiatry |
| Radiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the usefulness of I-123 metaiodobenzylguanidine (I-123 MIBG) myocardial scintigraphy in differentiation between dementia with Lewy bodies and Alzheimer's disease.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
To evaluate usefulness of the each parameter such as heart to mediastinum ratio (early image), heart to mediastinum ratio (delayed image), washout rate(%) and visual rating of 123I-MIBG myocardial scintigraphy in differentiating probable DLB from probable AD.
Key secondary outcomes
To evaluate the usefulness of each parameter of 123I-MIBG myocardial scintigraphy for early diagnosis of DLB after following up of possible DLB cases for 3 years, etc.
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -but assessor(s) are 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
I-123 MIBG myocardial scintigraphy
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
| 55 | years-old | <= |
Age-upper limit
| 85 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1. The patient diagnosed as probable DLB or possible DLB using the diagnostic criteria of DLB.
2. The patient diagnosed as probable AD using the diagnostic criteria of AD.
3. Exclusion: the patient who met either exclusion criteria of I-123 MIBG cardiac scintigraphy or others.
4. Exclusion: the patient who received brain MRI within 1 year to participate this study.
Key exclusion criteria
(1) Exclusion criteria related to I-123 MIBG caridac scintigrphy
Excluded are the conditions affecting I-123 MIBG myocardial accumulation as shown below:
1. The patient taking tricyclic antidepressants and/or reserpine.
2. The patient having cardiac failure.
3. The patient having ischemic heart disease within six months to participate in this study.
4. The patient having myocardial blood flow SPECT abnormalities within one year to participate in this study.
5. The patient planning surgeries of major arteries including revascularization within 2 months to participate in this study.
6. The patient having poorly controlled NIDDM [HbA1c >7.0%] or insulin therapy.
7. The patient having severe kidney dysfunction or renal failure [eGFR<15 mL/min/1.73m2].
8. The patient having hemodialysis.
9. The patient having pheochromocytoma.
10. The patient having amyloid neuropathy or other obvious peripheral neuropathy.
11. The patient having history of neoplasm within five years to participate in this study.
12. The patient having pregnant, nursing or probability of pregnancy.
(2) Other exclusion criteria
1. Parkinson's disease, cerebral infarction which affects cognitive function, Huntington disease, normal pressure hydrocephalus, brain tumor, progressive supranuclear palsy, epilepsy, subdural hematoma, multiple sclerosis, head injury with aftereffect.
2. The patient having infection or focal regions revealed by MRI such as cerebral infarction which affects cognitive function.
3. The patient having cardiac pacemaker, aneurysm clip, prosthetic valve, cochlear implant, or other metal implants.
4. The patient having history of alcohol or drug abuse, sever disease or unstable disease, deficiency of vitamin B12 or folic acid, syphilis, or thyroid dysfunction.
5. The case judged by clinical evaluation committee as inappropriate.
Target sample size
140
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masahito Yamada |
Organization
Kanazawa University School of Medical Science
Division name
Department of Neurology and Neurobiology of Aging
Zip code
Address
13-1 Takara-machi, Kanazawa, 920-8640, Japan
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Research project of DLB diagnosis
Division name
Secretariat
Zip code
Address
13-1 Takara-machi, Kanazawa, 920-8640, Japan
TEL
076-265-2292
Homepage URL
http://web.kanazawa-u.ac.jp/~med19/menu1/pages/dlb.html
dlb_mibg@med.kanazawa-u.ac.jp
Sponsor or person
Institute
Department of Neurology and Neurobiology of Aging, Kanazawa University School of Medical Science
Institute
Department
Personal name
Funding Source
Organization
Japan Foundation for Neuroscience and Mental Health
Organization
Division
Category of Funding Organization
Non profit foundation
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
筑波大学附属病院（茨城県）、順天堂大学医学部附属順天堂東京江東高齢者医療センター（東京都）、砂川市立病院（北海道）、岡山旭東病院（岡山県）、鳥取大学医学部附属病院（鳥取県）、東京医科大学病院（東京都）、東北大学病院（宮城県）、国立長寿医療センター病院（愛知県）、金沢大学附属病院（石川県）、京都府立医科大学附属病院（京都府）
Other administrative information
Date of disclosure of the study information
| 2010 | Year | 04 | Month | 05 | 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
No longer recruiting
Date of protocol fixation
| 2010 | Year | 01 | Month | 18 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 07 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2010 | Year | 03 | Month | 31 | Day |
Last modified on
| 2013 | Year | 04 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004142
