SDAF-PET

JRCT ID: jRCTs041180098

Registered date:14/03/2019

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: AD, FTLD
• Date of first enrollment: 10/04/2015
• Target sample size: 190
• Study type: Interventional
• Intervention(s): CSF,FDG-PET

Outcome(s)

• Primary Outcome: A difference in sensitivity between FDG-PET scans and p-tau181 in CSF

Secondary Outcome

1)A difference in accuracy rate between FDG-PET scans and p-tau181 in CSF.
2)A comparison of the diagnostic performance between clinical diagnosis at month 0 in consideration of CSF biomarkers (tau and Abeta42) versus FDG-PET.
3)Inter-group analyses and other evaluations of FDG-PET scans, CSF biomarkers, MRI scans, and neuropsychological tests between patients with AD and FTLD.

Key inclusion & exclusion criteria

• Age minimum: >= 55age old
• Age maximum: <= 84age old
• Gender: Both

Include criteria

1)Patients with AD or FTLD whose native language is Japanese.
2)Patients signing written informed consent. If a patient is considered incapable of consenting, his/her legally acceptable representative is required to sign the consent form.
3)Patients with a study partner who is able to understand and evaluate the patient's situation.
A study partner is required:
1. To be healthy both physically and mentally, and
2. To have contact with the patient for at least 10 hours per week and be able to accompany the patient for all the visits during the participation in the study (excluding the patient's son(s) or daughter(s) living in a remote location).
4)Patients aged 55 years and older but younger than 84 years (at the time of informed consent).
5)Patients who can undergo PET scans.

Exclude criteria

1)Patients who have a previous history of or are under treatment for alcoholism.
2)Patients who have a previous history of or are under treatment for epilepsy.
3)Patients who have no more than 6 years of education.
4)Patients with diabetes who are currently receiving insulin therapy.
5)Patients who are currently receiving treatment with antidepressants, antipsychotics, or long-term sedative hypnotics (including anxiolytics).
6)Patients who had a diagnosis of major depression or bipolar disorder within the past year, those who have a previous history of schizophrenia, or those who are considered to have difficulty in completing the protocol due to severe manifestation of psychiatric symptoms, such as anxiety or irritation, within the last 3 weeks.
7)Patients with concurrent serious medical conditions (such as malignancy, heart failure, liver impairment, renal impairment, or endocrine disease).
8)Patients with MRI evidence of local lesions, such as cerebral infarcts, which might affect cognitive function

Related Information

• Primary Sponsor: Ito Kengo
• Secondary Sponsor: Nihon Medi-physics Co.,Ltd.
• Source(s) of Monetary Support: National Center for Geriatrics and Gerontology
• Secondary ID(s): UMIN000016427