The usefulness of flutemetamol for diagnostic imaging of neurogenerative disease

JRCT ID: jRCTs051180214

Registered date:27/03/2019

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Alzheimer's disease,Dementia with Lewy Bodies,Parkinson's syndrome,Frontotemporal lober degeneration
• Date of first enrollment: 12/04/2019
• Target sample size: 100
• Study type: Interventional

Intervention(s)

Amyloid PET: Given the flutemetamol (2mL) intravenously
FDG-PET:Given the FDG scanR (2mL) intravenously

Outcome(s)

Primary Outcome

1. Differences in flutemetamol uptake in each patients
2. Differences in FDG uptake between patients and healthy controls.

• Secondary Outcome: Relationship between brain distribution of flutemetamol and clinical symptoms, neuropsychological examination, cerebrospinal fluid test and MRI

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

Healthy control
1. Ages 20 and over
2. Written informed consent

Patient
1. Diagnosed as neurogenerative disease related to tau protain (Alzheimer's disease, Dementia with Lewy Bodies, Frontotemporal lobar degeneration, Parkinson's syndrome) by clinical symptom, Neurological findings, MRI and cognitive function test.
2. Written informed consent

Exclude criteria

Healthy control
1. A person who has brain disease (Parkinson's disease, dementia related disease, etc.)
2. A person who has serious disease complications or who has a history of these and who is considered as inappropriate by researcher.
3. Pregnant, unwilling to practice contraception during the study, or lactating female.
4. Participated in nuclear medicine examination within 6 months.
5. Claustrophobia
6. Judged inappropriate as subject by investigator.

Patient
1. A person who is complicated by brain disease other than the disease concerned (including an obvious history of cerebral infarction) and taking a drug that effects on the central nervous system
2. A person who has serious disease complications or has a history of these and is judged to be unsuitable as a subject of this research by a doctor who is a researcher etc.
3. Pregnant, unwilling to practice contraception during the study, or lactating female.
4. Participated in nuclear medicine examination within 6 months.
5. Claustrophobia
6. Judged inappropriate as subject by investigator.

Related Information

• Primary Sponsor: Itoh Yoshiaki
• Source(s) of Monetary Support: Nihon Medi-Physics Co.,Ltd.