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Study on cardiac sympathetic nerve function in the diagnosis of dementia with Lewy bodies and Alzheimer's disease

Study on cardiac sympathetic nerve function in the diagnosis of dementia with Lewy bodies and Alzheimer's disease - Research project of DLB diagnossis

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000003419
Enrollment
140
Registered
2010-04-05
Start date
2010-07-01
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dementia with Lewy bodies Alzheimer&#39

Interventions

I-123 MIBG myocardial scintigraphy

Sponsors

Department of Neurology and Neurobiology of Aging, Kanazawa University School of Medical Science
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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.

Exclusion criteria

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.

Design outcomes

Primary

MeasureTime frame
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.

Secondary

MeasureTime frame
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.

Countries

Japan

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026