MEG dementia study

JRCT ID: jRCTs042220078

Registered date:20/10/2022

Basic Information

• Recruitment status: Pending
• Health condition(s) or Problem(s) studied: cognitively unimpaired, mild cognitive impairment/dementia due to Alzheime's disease
• Date of first enrollment: 20/10/2022
• Target sample size: 42
• Study type: Observational
• Intervention(s): Magnetoencephalography examination

Outcome(s)

• Primary Outcome: Primary outcomes were (i) the safety and tolerability of MEG examination, (ii) the maximum power in the left ventral Brodmann area 9/46 in the dorsolateral prefrontal cortex (DLPFC) and the power-ratio of the inferior parietal lobule (IPL)/ medial ventral occipital cortex (MVOcC) in the dorsal stream during the optic flow task.
• Secondary Outcome: Secondary outcomes were [i] brain activity at the dorsal stream and DLPFC during the optic flow task, and [ii] brain activity of mean frequency and alpha peak frequency at resting with eye closed mean frequency and alpha peak frequency

Key inclusion & exclusion criteria

• Age minimum: >= 65age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

Primary registration
[I] A full medical checkup examinee
[II] Patients with MCI due to AD at Kanazawa university hospital
[III] Patients with AD dementia at Kanazawa university hospital

Secondary registration
[IV] Cognitively unimpaired [CU] group
[V] AD-MCI group
[VI] AD group

[I] A full medical checkup examinee
[i] Age greater than 65 years
[ii] Individuals who have a full medical checkup at Kanazawa Advanced Medical Center
[iii] Written informed consent was obtained from the participant

[II] Patients with MCI due to AD at Kanazawa university hospital
[i] Age greater than 65 years
[ii] Diagnosis of probable mild cognitive impairment [MCI] due to Alzheimer's disease [AD] with high evidence of the pathophysiological process, according to the criteria of the National Institute on Aging Alzheimer's Association Workgroup [NIAAA].
[iii] Written informed consent ans assent were obtained from the legal representative and the patient, respectively.

[III] Patients with AD dementia at Kanazawa university hospital
[i] Age greater than 65 years
[ii] Diagnosis of probable AD dementia with high evidence of the pathophysiological process, according to the criteria of the National Institute on Aging Alzheimer's Association Workgroup [NIAAA].
[iii] Written informed consent ans assent were obtained from the legal representative and the patient, respectively.

[IV] Cognitively unimpaired [CU] group
[i] A full medical checkup examinee at the primary registration
[ii] Diagnosed as cognitive unimpaired by the investigators

[V] AD-MCI group
[i] Out patients of Kanazawa university hospital at the primary registration
[ii] Diagnosed as MCI due to AD by the investigators

[VI] AD group
[i] Out patients of Kanazawa university hospital at the primary registration
[ii] Diagnosed as AD dementia by the investigators

Exclude criteria

Primary registration
[I] A full medical checkup examinee
[II] Patients with MCI due to AD at Kanazawa university hospital
[III] Patients with AD dementia at Kanazawa university hospital

Secondary registration
[IV] Cognitively unimpaired [CU] group
[V] AD-MCI group
[VI] AD group

[I] A full medical checkup examinee
[i] Individuals who is unable to take an MRI scan, such as a claustrophobia or having any kind of metal in the body
[ii] Assessed as inappropriate to join the clinical trial by the investigator

[II] Patients with MCI due to AD at Kanazawa university hospital
[i] Individuals who is unable to take an MRI scan, such as a claustrophobia or having any kind of metal in the body
[ii] Assessed as inappropriate to join the clinical trial by the investigator

[III] Patients with AD dementia at Kanazawa university hospital
[i] Individuals who is unable to take an MRI scan, such as a claustrophobia or having any kind of metal in the body
[ii] Assessed as inappropriate to join the clinical trial by the investigator

[IV] Cognitively unimpaired [CU] group
[i] Assessed as inappropriate by the investigator

[V] AD-MCI group
[i] Individuals who have a full medical checkup at Kanazawa Advanced Medical Center
[ii] Assessed as inappropriate by the investigator

[VI] AD group
[i] Individuals who have a full medical checkup at Kanazawa Advanced Medical Center
[ii] Assessed as inappropriate by the investigator

Related Information

• Primary Sponsor: Ono Kenjiro