Back to resultsBiodistribution, Pharmacokinetics, and Safety of F-18 THK-5351 PET in Alzheimer's Disease Patients and Healthy Subjects.(Positron Emission Tomograph ) (PET)
Primary Purpose
Alzheimer's Disease
Status
Completed
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
F-18 THK-5351
Sponsored by
About this trial
This is an interventional diagnostic trial for Alzheimer's Disease focused on measuring F-18 THK-5351 PET
Eligibility 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.
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
F-18 THK-5351
Arm Description
F-18 THK-5351 imaging
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
Full Information
NCT ID
NCT02686216
First Posted
January 15, 2016
Last Updated
January 25, 2021
Sponsor
Chang Gung Memorial Hospital
1. Study Identification
Unique Protocol Identification Number
NCT02686216
Brief Title
Biodistribution, Pharmacokinetics, and Safety of F-18 THK-5351 PET in Alzheimer's Disease Patients and Healthy Subjects.(Positron Emission Tomograph )
Acronym
PET
Official Title
Biodistribution, Pharmacokinetics, and Safety of F-18 THK-5351 PET in Alzheimer's Disease Patients and Healthy Subjects
Study Type
Interventional
2. Study Status
Record Verification Date
November 2016
Overall Recruitment Status
Completed
Study Start Date
December 2015 (undefined)
Primary Completion Date
April 2016 (Actual)
Study Completion Date
November 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Chang Gung Memorial Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alzheimer's Disease
Keywords
F-18 THK-5351 PET
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
24 (Actual)
8. Arms, Groups, and Interventions
Arm Title
F-18 THK-5351
Arm Type
Experimental
Arm Description
F-18 THK-5351 imaging
Intervention Type
Drug
Intervention Name(s)
F-18 THK-5351
Intervention Description
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.
Primary Outcome Measure Information:
Title
The primary outcome measures are to evaluate the dosimetry of novel radiotracer F-18 THK-5351 in human.
Description
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.
Time Frame
One year
Secondary Outcome Measure Information:
Title
Optimal scanning time for brain imaging using F-18 THK-5351.
Description
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.
Time Frame
One year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
12. IPD Sharing Statement
Citations:
PubMed Identifier
28336780
Citation
Hsiao IT, Lin KJ, Huang KL, Huang CC, Chen HS, Wey SP, Yen TC, Okamura N, Hsu JL. Biodistribution and Radiation Dosimetry for the Tau Tracer 18F-THK-5351 in Healthy Human Subjects. J Nucl Med. 2017 Sep;58(9):1498-1503. doi: 10.2967/jnumed.116.189126. Epub 2017 Mar 23.
Results Reference
derived
Learn more about this trial
Biodistribution, Pharmacokinetics, and Safety of F-18 THK-5351 PET in Alzheimer's Disease Patients and Healthy Subjects.(Positron Emission Tomograph )
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