Alzheimer's Disease
Conditions
Keywords
F-18 THK-5351 PET
Brief summary
Biodistribution, pharmacokinetics, and safety of F-18 THK-5351 PET in Alzheimer's disease patients and healthy subjects.
Detailed description
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.
Interventions
DRUGF-18 THK-5351
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.
Sponsors
Chang Gung Memorial Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to 90 Years
Healthy volunteers
Yes
Inclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The primary outcome measures are to evaluate the dosimetry of novel radiotracer F-18 THK-5351 in human. | One year | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Optimal scanning time for brain imaging using F-18 THK-5351. | One year | 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. |
Outcome results
None listed