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An exploratory study to evaluate brain AMPA receptor density using [11C]K-2 PET and to investigate its association with menopausal symptoms in women.

Basic Information

Recruitment status	Recruiting
Health condition(s) or Problem(s) studied	Healthy females or females with menopausal disorder
Date of first enrollment	09/02/2026
Target sample size	60
Countries of recruitment
Study type	Interventional
Intervention(s)	Administration of an unapproved drug

Outcome(s)

Primary Outcome

The total MRS score and voxel-wise brain AMPA receptor density measured by [11C]K-2 PET.

Secondary Outcome

1.The total MRS score and voxel-wise relative brain AMPA receptor density measured by [11C]K-2 PET (whole-brain referenced SUVR(SUVRWB)). 2. Voxel-wise brain AMPA receptor density measured by [11C]K-2 PET in asymptomatic and severe MRS groups 3. Voxel-wise relative brain AMPA receptor density measured by [11C]K-2 PET (SUVRWB) in asymptomatic and severe MRS groups 4. Voxel-wise brain AMPA receptor density measured by [11C]K-2 PET in relation to each MRS subscale 5. Voxel-wise relative brain AMPA receptor density measured by [11C]K-2 PET (SUVRWB) in relation to each MRS subscale 6. Voxel-wise brain AMPA receptor density measured by [11C]K-2 PET and serum hormone levels (E2, FSH, LH, P4, AMH) 7. Voxel-wise relative brain AMPA receptor density measured by [11C]K-2 PET (SUVRWB) and serum hormone levels (E2, FSH, LH, P4, AMH) 8. Voxel-wise brain AMPA receptor density measured by [11C]K-2 PET before and after menopause 9. Voxel-wise relative brain AMPA receptor density measured by [11C]K-2 PET (SUVRWB) before and after menopause 10.Voxel-wise brain AMPA receptor density measured by [11C]K-2 PET in relation to the time since the last menstruation in postmenopausal participants 11. Voxel-wise relative brain AMPA receptor density measured by [11C]K-2 PET (SUVRWB) in relation to the time since the last menstruation in postmenopausal participants

Key inclusion & exclusion criteria

Age minimum	>= 40age old
Age maximum	< 60age old
Gender	Female
Include criteria	(1) Female participants aged 40 years or older and younger than 60 years at the time of obtaining informed consent. (2) Participants who are judged to have sufficient decision-making capacity for providing informed consent based on the MacArthur Competence Assessment Tool (MacCAT), and who provide written informed consent to participate in this study.
Exclude criteria	(1) Individuals with abnormal thyroid function at screening, according to the Japan Thyroid Association Guidelines for the Diagnosis of Thyroid Diseases. (2) Individuals diagnosed with schizophrenia, autism spectrum disorder, depression, or bipolar disorder by a board-certified psychiatrist at screening. (3) Individuals with a history of psychiatric disorders. (4) Individuals with neurological diseases including neurodegenerative disorders, epilepsy, or a history of cerebral hemorrhage or cerebral infarction. (5) Individuals who are hypersensitive to alcohol. (6) Individuals who require continuous administration of perampanel or topiramate. (7) Individuals who are pregnant, breastfeeding, or intend to become pregnant during the study period. (8) Individuals confirmed to have serum hCG levels equal to or greater than 6 mIU per mL on screening blood tests. (9) Individuals with a history of oophorectomy or hysterectomy. (10) Individuals with a history of hormone therapy for breast, ovarian, or endometrial cancer, or those currently undergoing such therapy. (11) Individuals who have used or are currently using oral contraceptives or low-dose estrogen progestin combinations within 6 months prior to study participation. (12) Individuals who have used or are currently using progesterone preparations within 6 months prior to study participation. (13) Individuals who have a history of or are currently receiving hormone replacement therapy for menopausal symptoms. (14) Individuals who have used placenta-derived preparations within 1 month prior to PET imaging. (15) Individuals with a history of or currently undergoing radiation therapy or chemotherapy. (16) Individuals confirmed to test positive for addictive substances, excluding prescribed medications, in urine drug screening at screening. (17) Individuals unsuitable for 3 Tesla MRI, such as those with implanted metallic devices not compatible with 3 Tesla MRI, tattoos or permanent makeup larger than one-point size, severe claustrophobia, or body size incompatible with the MRI scanner. (18) Individuals with a history of brain tumor. (19) Individuals with abnormal vital signs at screening or on the day of PET imaging, such as systolic blood pressure equal to or greater than 140 mmHg, pulse rate equal to or greater than 80 beats per minute, or body temperature equal to or greater than 37.5 degrees Celsius, unless the principal investigator or a sub-investigator determines that participation is medically acceptable after comprehensive evaluation. (20) Individuals with AST, ALT, or ALP levels equal to or greater than 2.5 times the institutional upper limit, or serum creatinine equal to or greater than 2.0 mg per dL on screening blood tests. (21) Individuals who have participated in other clinical trials or investigational drug or nuclear medicine studies within the past 6 months. (22) Individuals deemed ineligible for study participation by the principal investigator or sub-investigator for any other reason.