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

NCT02686216 | Completed Phase 1

• 1 other identifier: 104-2710A
• Study Type: interventional
• Target: 24
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Alzheimer's Disease

Keywords

F-18 THK-5351 PET

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Optimal scanning time for brain imaging using F-18 THK-5351.

  One year

Study Arms (1)

F-18 THK-5351

EXPERIMENTAL

F-18 THK-5351 imaging

Drug: F-18 THK-5351

Interventions

F-18 THK-5351 DRUG

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.

F-18 THK-5351

Eligibility Criteria

• Age: 20 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Neurologic testing. (MMSE 24-30, Wechsler Logical Memory score \>5).
• Subjects must provide written inform consent.
• 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.)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Chang Gung Memorial Hospital: lead

Related Publications (1)

• 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.

  PMID: 28336780 DERIVED

MeSH Terms

Conditions

Alzheimer Disease

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 15, 2016
• First Posted: February 19, 2016
• Study Start: December 1, 2015
• Primary Completion: April 1, 2016
• Study Completion: November 1, 2016
• Last Updated: January 27, 2021

Record last verified: 2016-11