CUPAB study

JRCT ID: jRCTs032200043

Registered date:01/06/2020

Basic Information

• Recruitment status: Not Recruiting
• Health condition(s) or Problem(s) studied: Mild cognitive impairment, Alzheimer's Disease (AD) , non- AD, Cognitively unimpaired individuals
• Date of first enrollment: 02/07/2020
• Target sample size: 200
• Study type: Interventional
• Intervention(s): Injection of Flutemetamol, PET scan, brain MRI scan, blood sampling and Neuropsychological test.

Outcome(s)

• Primary Outcome: Diagnostic accuracy of the plasma Amyloid beta biomarker to predict presence or absence of abnormal Amyloid beta deposition in the brain.

Secondary Outcome

1) Sensitivity of the plasma Amyloid beta biomarker.
2) Specificity of the plasma Amyloid beta biomarker.
3) Probability of adverse events.

Key inclusion & exclusion criteria

• Age minimum: >= 50age old
• Age maximum: <= 100age old
• Gender: Both

Include criteria

Cognitively unimpaired individuals;
1) Written informed consent is obtained.
2) General condition, visual acuity and hearing ability are sufficiently good to proceed examinations required for this study.

Mild cognitive impairment, Alzheimer's Disease (AD) , non- AD;
1) Written informed consent is obtained.The subject's legally acceptable representative must provide the written informed consent form if the subject is unable to provide informed consent.
2) General condition, visual acuity and hearing ability are sufficiently good to proceed examinations required for this study.
3) Diagnosed with any of the following diseases at informed consent.
Mild cognitive impairment
Alzheimer's Disease (AD)
non- AD

Exclude criteria

Cognitively unimpaired individuals;
1) GDS (Geriatric depression scale) > 6
2) Having difficulty to keep supine position due to deformity or dysfunction in the muscle-skeletal system, e.g. problems of the spine or hip joint.
3) Having contraindications for MRI scans.

Mild cognitive impairment, AD , non- AD;
1) GDS > 11
2) Having difficulty to keep supine position due to deformity or dysfunction in the muscle-skeletal system, e.g. problems of the spine or hip joint.
3) Having contraindications for MRI scans.

Related Information

• Primary Sponsor: Nakamura Akinori