Quantitative evaluation of [18F] flutemetamol PET for patients suspected of Alzheimer's dementia; a multicenter study

JRCT ID: jRCTs031180321

Registered date:18/03/2019

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Alzheimer disease
• Date of first enrollment: 11/04/2019
• Target sample size: 100
• Study type: Interventional
• Intervention(s): N/A

Outcome(s)

• Primary Outcome: Qualitative evaluation and quantitative evaluation index of the amyloid PET image
• Secondary Outcome: Diagnostic confidence before and after amyloid PET

Key inclusion & exclusion criteria

• Age minimum: Not applicable
• Age maximum: Not applicable
• Gender: Both

Include criteria

Patients with cognitive impairment suspected of AD, regardless of age and gender.
Patients suspected of having AD based on NIA-AA or DSM-V
Patients who underwent brain MRI (T1 weighted image (3D imaging is preferable), T2 weighted image, FLAIR image) up to 60 days before registration
Patients who obtain consent from the patients themselves or from the legally acceptable representative in writing

Exclude criteria

Cognitively normal patients
Patients with mild cognitive impairment (MCI)
Patients with brain lesions (brain tumor, vascular malformation, cortical infarction, etc.) in brain MRI
Patients with severe allergy to alcohol or polysorbate 80 (Solubilizer)
Pregnant women, lactating women and those who may be pregnant
Patients who are judged inappropriate by chief researchers

Related Information

• Primary Sponsor: Matsuda Hiroshi
• Source(s) of Monetary Support: Nihon Medi-Physics Co. Ltd.