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

NCT ID: NCT02686216

Last Updated: 2021-01-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-12-31
• Study Completion Date: 2016-11-30

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.

Conditions

Alzheimer's Disease

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

F-18 THK-5351

F-18 THK-5351 imaging

Group Type: EXPERIMENTAL

F-18 THK-5351

Intervention Type: 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.

Interventions

F-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.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 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.)

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.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Chang Gung Memorial Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

References

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.

Reference Type: DERIVED

PMID: 28336780 (View on PubMed)

Other Identifiers

104-2710A

Identifier Type: -

Identifier Source: org_study_id