A pilot study to validate the imaging value obtained from [11C]K-2 PET imaging in major cognitive disorders.

JRCT ID: jRCTs031190262

Registered date:19/03/2020

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Major cognitive disorders
• Date of first enrollment: 27/03/2020
• Target sample size: 92
• Study type: Interventional
• Intervention(s): Single intravenous administration of [11C]K-2, which radiation dose should be aroud 370MBq ( 333MBq - 407MBq).

Outcome(s)

• Primary Outcome: SUVR and BPND,which reference domains are white matter, in each diagnostic category in atrophic cortex.

Secondary Outcome

1.The basic statistics of neuropsychological tests in each diagnostic category.
2.The basic statistics of MDS-UPDRS Part 3 in each diagnostic category.
3.The basic statistics of MDS-UPDRS Part 1 and 2 in three diagnostic categories, DLB, PSP and CBS.
4.The basic statistics of SUVRs, which reference domain is white matter, in each diagnostic category in each defined brain region.
5.The basic statistics of BPNDs, which reference domain is white matter, in each diagnostic category in each defined brain region.
6.The results of neuropsychological tests and SUVRs in each diagnostic category and in whole subjects in each defined brain region.
7.The disease durations and SUVRs in each diagnostic category and in whole subjects in each defined brain region .
8.The results of neuropsychological tests and BPNDs in each diagnostic category and in whole subjects in each defined brain region, .
9.The disease durations and BPNDs in each diagnostic category and in whole subjects in each defined brain region.
10.PSPRS and SUVRs in PSP groups in each defined brain region.
11.PSPRS and BPNDs in PSP groups in each defined brain region.
12.MDS-UPDRS Part 3 and SUVRs in each diagnostic category and in whole subjects in each defined brain region.
13.MDS-UPDRS Part 3 and BPNDs in each diagnostic category and in whole subjects in each defined brain region.
14.MDS-UPDRS Part 1 and 2 and SUVRs in three diagnostic categories, DLB, PSP and CBS and in the whole subjects in the groups in each defined brain region.
15.MDS-UPDRS Part 1 and 2 and BPNDs in three diagnostic categories, DLB, PSP and CBS and in the whole subjects in the groups in each defined brain region.
16.SUVRs computed in voxels clustered and the results of neuropsychological tests in each diagnostic category and in whole subjects.
17.BPNDs computed in voxels clustered and the results of neuropsychological tests in each diagnostic category and in whole subjects.
18.SUVRs computed in voxels clustered and PSPRS in PSP groups.
19.BPNDs computed in voxels clustered and PSPRS In PSP groups.
20.SUVRs computed in voxels clustered and MDS-UPDRS Part 3 in each diagnostic category and in whole subjects.
21.BPNDs computed in voxels clustered and MDS-UPDRS Part 3 in each diagnostic category and in whole subjects,
22.SUVRs computed in voxels clustered and MDS-UPDRS Part 1 and 2 in three diagnostic categories, DLB, PSP and CBS and in the whole subjects in the groups.
23.BPNDs computed in voxels clustered and MDS-UPDRS Part 1 and 2In three diagnostic categories, DLB, PSP and CBS and in the whole subjects in the groups.

Brain regions are defined as below; superior frontal gyrus, middle frontal gyrus, inferior frontal gyrus, straight gyrus, precentral gyrus, anterior orbital gyrus, posterior orbital gyrus, lateral orbital gyrus, medial orbital gyrus, hippocampus, amygdala, parahippocampal gyrus, fusiform gyrus, superior temporal gyrus anterior and posterior part, middle and inferior temporal gyrus, posterior temporal lobe, post central gyrus, superior parietal gyrus, inferiolateral remainder of parietal lobe, lingual gyrus, cuneus, lateral remainder of occipital lobe, insula, subgenus anterior cingulate gyrus, subcallosal are, pre-subgenual anterior cingulate gyrus, caudate nucleus, nucleus accumbens, putamen, thalamus, palladium, substantia nigra, cerebellum, brainstem, and corpus callosum. Analyze in lower item of neuropsychological tests, MDS-UPDRS and PSPRS will be also conducted.

Key inclusion & exclusion criteria

• Age minimum: >= 40age old
• Age maximum: <= 99age 12month 48weeks old
• Gender: Both

Include criteria

1. 40 years old older and younger than 100 years old at the registration.
2. Patients diagnosed with AD or LBD or FTD or PSP or CBS or MCI.
3. Patients who can express intents to participate in this research with written documents on their own or by substitutes.
4. Patients who can visit Yokohama City University Hospital with their caregiver.

Exclude criteria

1. Patients who can not be performed head MRI due to their implanted metals, claustrophobia, tattoo or art makeup.
2. Patients who have a alcohol hypersensitivity.
3. Patients who have a history or a plan of brain surgery.
4. Patients pointed out neurological disorders independent of major cognitive disorders or MCI.
5. Patients who have a plan of RI examination 72 hours before AMPA PET imaging.

Related Information

• Primary Sponsor: Abe Hiroki
• Secondary Sponsor: Takahashi Takuya
• Source(s) of Monetary Support: Japan Agency for Medical reserach and Development