AMPA receptor and Amyloid beta PET imagings for elderly epilepsy and Alzheimer's disease.

JRCT ID: jRCTs031210312

Registered date:14/09/2021

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: elderly epilepsy, Alzheimer's disease, mild cognitive impairment
• Date of first enrollment: 05/10/2021
• Target sample size: 60
• Study type: Interventional

Intervention(s)

1) Vanous injection of [11C] K-2 (370MBq plus minus 10%)
2) Vanous injection of [18F] florbetapir(370MBq plus minus 10%)
3) Vanous injection of[11C] flumazenil(370MBq plus minus 10%)

Outcome(s)

• Primary Outcome: AMPAR_AImax for each group.

Secondary Outcome

1. SUVR ration between [11C]K-2 and [11C]FMZ for each participant.
2. [11C] FMZ_AImax for each group.
3. [18F] florbetapir_AImax for each group.
4. Comparison among [18F] florbetapir, [11C]K-2 and [11C]FMZ imagings for each participant.
5. Frequency analysis of EEG on PET imaging (SPM analysis).
6. Dipole analysis of EEG on PET imaging.
7. Classification of each endpoint based on the accumulation of [18F] florbetapir.

Key inclusion & exclusion criteria

• Age minimum: >= 60age old
• Age maximum: < 90age old
• Gender: Both

Include criteria

Common inclusion criteria (2 is limited to elderly epilepsy and early AD/MCI. )
1. 60 years older and under 90 years old at the registration.
2. A Patient who can express his or her intent to participate in this research with written documents by himself or herself. When a patient is unable to write his or her sign due to their ages and diseases, a substitute who was asked to write his or her sign by the patient can express intents to participate in this research with written documents in stead of the patient.
Inclusion criteria for elderly epilepsy
1. Diagnosed with epilepsy according to the ILAE definition 2014.
2. Onset age of 60 years or older.
Inclusion criteria for early AD and MCI
Diagnosed as AD or MCI due to AD based on the NIA-AA criteria.
Inclusion criteria for non-epileptic and non-dementia elderly control
1. Not diagnosed as dementia.
2. With amnesia, but with no trouble in their daily lives.
3. Not diagnosed as epilepsy.

Exclude criteria

Common exclusion criteria -excerpt-
1. History with open-scalpe brain surgery.
2. Diagnosed with brain tumor or brain trauma at the registration.
3. Unable to undergo 3T head MRI.

Related Information

• Primary Sponsor: Abe Hiroki
• Source(s) of Monetary Support: Eisai Co., Ltd.