A pilot study to evaluate AMPA receptors densities in striatum with [11C]K-2 PET imaging in Parkinson's disease.

JRCT ID: jRCTs031200448

Registered date:29/03/2021

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Parkinson's disease
• Date of first enrollment: 09/07/2021
• Target sample size: 15
• Study type: Interventional
• Intervention(s): Single intravenous administration of [11C]K-2, which radiation dose should be around 370 MBq (330-407 MBq)

Outcome(s)

Primary Outcome

SUVR (reference domains ; white matter) in right and left striatum
dSUVRstr; striatum SUVR in higher SBR in DAT SPECT
ndSUVRstrl; striatum SUVR in lower SBR in DAT SPECT

Secondary Outcome

1. dSUVRstr and MDS-UPDRS part3
2. ndSUVRstr and MDS-UPDRS part3
3. dSUVRstr and MDS-UPDRS part3 lower items.
4. nd SUVRstr and MDS-UPDRS part3 lower items.
5. dSUVRstr minus ndSUVRstr and MDS-UPDRS part3.
6. dSUVRstr minus ndSUVRstr and MDS-UPDRS part3 lower items.
7. SUVR (reference domains ; white matter) computed in voxels in whole brain and MDS-UPDRS part3
8. SUVR (reference domains ; white matter) computed in voxels in whole brain and MDS-UPDRS part3
lower items.
9. SUVR (reference domains ; white matter) computed in voxels in whole brain and MoCA-J
10. SUVR (reference domains ; whole brain) computed in voxels in whole brain and MDS-UPDRS part3
11. SUVR (reference domains ; whole brain) computed in voxels in whole brain and MDS-UPDRS part3
lower items.
12. SUVR (reference domains ; whole brain) computed in voxels in whole brain and MoCA-J
13. MDS-UPDRS part1, 2 and total score of MDS-UPDRS.

Key inclusion & exclusion criteria

• Age minimum: >= 40age old
• Age maximum: < 81age old
• Gender: Both

Include criteria

1. 40 years old older and younger than 81 years old at the registration
2. Diagnosed as clinically established Parkinson's disease with MDS PD criteria 2015.
3. Underwent DAT SPETC within a year.
4. Patients who can express intents to participate in this research with written documents.
A person who decides to participate in this research at his / her own free will can obtain written consent. However, when the consent explanation document cannot be read or written by the disease's symptoms, a witness will give his/her written consent. The witnesses are adults who are not unduly affected by those involved in this study and can take a third-party position. When he/she can not provide informed consent, it is possible to provide written consent with the substitute person's signature. A substitute person is an adult who is equivalent to his / her spouse, parents, compatriots, children, family members living together, or close relatives and can represent the will and interests.

Exclude criteria

1. Patients who can not anwser their name, birth date or current month.
2. Patients who have a history of epilepsy.
3. Patients with dyalysis.
4. Patients who can not undergo head 3T-MRI.
5. Patietnts who underwent non-invasive brain stimulation therapy within a year.
6. Patients who have symptoms which could not be explained by PD.

Related Information

• Primary Sponsor: Abe Hiroki
• Source(s) of Monetary Support: Japan Society for the Promotino of Science