A study aimed at exploring the relationship between brain imaging, cognitive function and EEG in healthy individuals and patients with Alzheimer's disease.

JRCT ID: jRCT1021210071

Registered date:02/03/2022

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Alzheimer's disease
• Date of first enrollment: 04/04/2022
• Target sample size: 95
• Study type: Interventional

Intervention(s)

Cognitive function test
EEG test
Amyloid PET scan

Outcome(s)

• Primary Outcome: Relationship between qualitative assessment of amyloid beta and features obtained from EEG (EEG features)

Secondary Outcome

The relationship between the MMSE and EEG features (EEG features)
Relationship between MoCAJ and features obtained from EEG (EEG features)
Summary statistics for MMSE and MoCAJ
Amyloid beta Quantitative Assessment
Relationship between quantitative assessment of amyloid beta and features obtained from EEG (EEG features)

Key inclusion & exclusion criteria

• Age minimum: >= 45age old
• Age maximum: <= 80age old
• Gender: Both

Include criteria

<Healthy subjects>
(1) Those who are between 45 and 80 years old at the time of obtaining consent.
(2) Those who have received sufficient explanation and understanding of this research, and who have given their free and voluntary consent in writing.
<patients with Alzheimer's disease>
(1) Patients who are between 45 and 80 years of age at the time of consent.
(2) Patients who have been diagnosed with probable Alzheimer's disease (AD) according to the NIA-AA diagnostic criteria1).
(3) Those who have received sufficient explanation and understanding of this research and who have given their free and voluntary consent in writing. (4) A person who has been fully informed about this research and understands it, and who has given written consent of his/her own free will. Or, if the person lacks sufficient capacity to give consent, a person who has given written consent from a substitute.

Exclude criteria

Healthy subjects
Those with a history of or complications from neurological diseases
Those who have performed MMSE or MoCAJ within 6 months
Those with mental illness
Those who are taking medication that may affect EEG measurement
Those with severe complications (malignant tumor, myocardial infarction, heart failure, etc.) that may affect the amyloid beta PET CT test and EEG measurement
Those whose physician judges that it is difficult to perform amyloid beta PET CT test due to some physical conditions (e.g., allergy to flutemetamol (18F))
Those who, for some reason (frontal trauma, frontal skin disease, skull defect, blindness, etc.), are considered to have difficulty in performing EEG measurement and tasks during EEG measurement
Pregnant women, nursing mothers, and those who wish to become pregnant during the research period
Those who are participating in other research.
Other persons whom the researcher, etc. judges to be undesirable as subjects of this research.

Patients with Alzheimer's disease
Patients with a history of or complications from neurological diseases other than Alzheimer's disease
Patients with mental illness
Patients who are taking medication that may affect EEG measurement
Patients with severe complications (malignant tumor, myocardial infarction, heart failure, etc.) that may affect amyloid beta PETCT test and EEG measurement
Patients whose physician judges that it is difficult to perform amyloid beta PET CT test due to some physical conditions (e.g., allergy to flutemetamol (18F))
Patients who, for some reason (frontal trauma, frontal skin disease, skull defect, blindness, etc.), are considered to have difficulty in performing EEG measurement and tasks during EEG measurement
Pregnant women, nursing mothers, and those who wish to become pregnant during the research period
Those who are participating in other research.
Other persons whom the researcher, etc. judges to be undesirable as subjects of this research.

Related Information

• Primary Sponsor: Takanami Kentaro