The usefulness of flutemetamol for diagnostic imaging of neurogenerative disease

• Register: JPRN
• Last refreshed on: 17 October 2023
• Main ID: JPRN-jRCTs051180214
• Date of registration: 27/03/2019
• Prospective Registration: Yes
• Primary sponsor: Itoh Yoshiaki
• Public title: The usefulness of flutemetamol for diagnostic imaging of neurogenerative disease
• Scientific title: The usefulness of brain amyloid image using flutemetamol and glucose metabolism for the neurogenerative disease - The usefulness of brain amyloid image using flutemetamol and glucose metabolism for the neurogenerative disease
• Date of first enrolment: 12/04/2019
• Target sample size: 100
• Recruitment status: Recruiting
• URL: https://jrct.niph.go.jp/latest-detail/jRCTs051180214
• Study type: Interventional
• Study design: non-randomized controlled trial, open(masking not used), no treatment control/standard of care control, parallel assignment, diagnostic purpose
• Phase: N/A

Contacts

• Name: Yoshiaki Itoh
• Affiliation: Osaka Metropolitan Univesity Hospital

• Name: Yoshiaki Itoh
• Affiliation: Osaka Metropolitan University Hospital

Key inclusion & exclusion criteria

Inclusion 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
Exclusion 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.

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

Health Condition(s) or Problem(s) studied

Alzheimer's disease,Dementia with Lewy Bodies,Parkinson's syndrome,Frontotemporal lober degeneration
Alzheimer's disease, Dementia with Lewy Bodies, Parkinson's syndrome, Frontotemporal lober degeneration, Parkinson's disease, Mild cognitive impairment, Non-Alzheimer's disease, Progressive aphasia, Neurodegenerative disease, Cerebral corticobasal degeneration, Progressive supranuclear palsy

Alzheimer's disease, Dementia with Lewy Bodies, Parkinson's syndrome, Frontotemporal lober degeneration, Parkinson's disease, Mild cognitive impairment, Non-Alzheimer's disease, Progressive aphasia, Neurodegenerative disease, Cerebral corticobasal degeneration, Progressive supranuclear palsy

Intervention(s)

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

Primary Outcome(s)

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

Secondary Outcome(s)

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

Source(s) of Monetary Support

Nihon Medi-Physics Co.,Ltd.

Ethics review

Status: Approval
Approval date:
Contact:

[e-mail]

Osaka Metropolitan University Hospital Certified Review Board

[phone]

[e-mail]