Biodistribution, Pharmacokinetics, and Safety of F-18 THK-5351 PET in Alzheimer's Disease Patients and Healthy Subjects.(Positron Emission Tomograph )

Study Overview
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Brief Summary
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Biodistribution, pharmacokinetics, and safety of F-18 THK-5351 PET in Alzheimer's disease patients and healthy subjects.

Detailed Description
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Totally 24 subjects age 20-90 including 12 healthy cognitively intact subjects and 12 probably Alzheimer's dementia patients with NINCDS-ADRDA criteria. For disease subjects, caregiver should be able to report activities of daily living and their mental status. Patient should be able to give informed consent or have a caregiver give consent with subject assent.

Official Title
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Biodistribution, Pharmacokinetics, and Safety of F-18 THK-5351 PET in Alzheimer's Disease Patients and Healthy Subjects

Conditions
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Alzheimer's Disease

Intervention / Treatment
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* Drug: F-18 THK-5351


Participation Criteria
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Eligibility Criteria
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Healthy Inclusion Criteria: Neurologic testing. (MMSE 24-30, Wechsler Logical Memory score >5). Subjects must provide written inform consent. Patients with AD Inclusion Criteria: Diagnosis of AD according to the clinical diagnostic criteria of possible AD with NINCDS-ADRDA criteria MMSE 20-26, Clinical dementia rating 0.5 or 1, Wechsler Logical Memory score<=4 Patient who provide a written informed consent prior to study entry. (If the patient is incapable informed consent, the caregiver may consent on behalf of the patient. The caregiver should be able to report activities of daily living and their mental status.) Exclusion Criteria: Pregnant or become pregnant Current breast feeding Clinically significant abnormal laboratory values Unstable medical or psychiatric illness. Cardiovascular disease (cardiac surgery or myocardial infarction within the last 6 months; unstable angina; decompensated congestive heart failure; significant cardiac arrhythmia; congenital heart disease). History of drug or alcohol abuse within the last year, or prior prolonged history of abuse. --History of severe allergic or anaphylactic reactions particularly to the tested drugs . PI assessment with high risk.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: F-18 THK-5351<br>F-18 THK-5351 imaging | Drug: F-18 THK-5351<br>* Totally 24 subjects age 20-90 including 12 healthy cognitively intact subjects and 12 probably AD patients with NINCDS-ADRDA criteria. For disease subjects, caregiver should be able to report activities of daily living and their mental status. Patient should be able to give informed consent or have a caregiver give consent with subject assent.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The primary outcome measures are to evaluate the dosimetry of novel radiotracer F-18 THK-5351 in human. | Time-integrated activity in each organ will be calculated by trapezoidal integration of the first 45 min of the organ's time-activity curve, followed by a single-exponential fit to the remaining data points (based on the 4 whole-body images) extrapolate to infinity, all base on non-decay-corrected data.Residence times will be obtained by dividing the time-integrated activity by the injected amount of activity. | One year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Optimal scanning time for brain imaging using F-18 THK-5351. | PET data will be acquired using SIMENS PET/CT or PET/MRI scanner with an axial field of view of 15.7cm. For PET/CT protocol, a 50-min dynamic brain PET scan (6x10s, 4x60s, 5x180s, 6x300s) will be started simultaneously with the injection of 10mCi of F-18 THK-5351 after a low-dose CT scan for patient positioning and attenuation correction. | One year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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F-18 THK-5351 PET