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


Email



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

Email

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


Email



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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name