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A Phase I [18F]THK-5351 Positron Emission Tomography Study in Healthy Subjects and Alzheimer's Disease | Clinical Trials | Clareo Health

COMPLETEDPHASE1

A Phase I [18F]THK-5351 Positron Emission Tomography Study in Healthy Subjects and Alzheimer's Disease

A Phase I [18F]THK-5351 Positron Emission Computed Tomography Study of Biodistribution, Pharmacokinetics and Safety in Cognitively Healthy Subjects and Patients With Alzheimer's Disease

NCT03112096•Asan Foundation

View on ClinicalTrials.gov

Summary

This is a study to evaluate biodistribution, pharmacokinetics and safety of \[18F\]THK-5351 positron emission computed tomography in Cognitively Healthy Subjects and Patients with Alzheimer's Disease.

Detailed Description

This is a study to evaluate biodistribution, pharmacokinetics and safety of \[18F\]THK-5351 positron emission computed tomography. Ten cognitively healthy subjects and 10 patients with Alzheimer's Disease will be enrolled. The primary outcome measures are to evaluate pharmacokinetics of \[18F\]THK-5351 Positron Emission Tomography imaging . Tracer biodistribution will be evaluated by global and regional standardized uptake value ratio of \[18F\]THK-5351 in the brain. Safety. For safety assessment, a physical examination, Electrocardiogram and vital signs will be performed at baseline and at the completion of all imaging to assess for interval change.

Eligibility

Age

20 - 80 years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•In order to be eligible for participation in this trial, the subject must:
•1. Be able to read at a 6th grade level or equivalent, (as determined by the investigator, and must have a history of academic achievement and/or employment sufficient to exclude mental retardation.)
•2. Be able to speak, read, hear, and understand the language of the trial staff, and the informed consent form, and possess the ability to respond verbally to questions, follow instructions, and complete questionnaires and detailed neuropsychological test.
•3. Have results of clinical laboratory tests/physical examination, vital signs, and Electrocardiogram within normal limits (at 45 days prior to \[18F\]THK-5351 Positron Emission Tomography scan ) or clinically acceptable to the investigator at screening.
•4. Be able to possess the ability to respond verbally to questions, follow instructions, and underwent research assessment, including brain images based on the investigator's judgment. Each subject is also able and willing to adhere visit schedules.
•5. If female, not be of childbearing potential as indicated by one of the following
•1. has reached natural menopause, defined as ≥ 24 months of spontaneous amenorrhea or
•2. has had a hysterectomy; or
•3. has had a bilateral oophorectomy (with or without a hysterectomy) and more than 6 weeks have passed since the surgery.
•6. Each subject (or legal representative) must sign the informed consent form in accordance with local requirements after the scope and nature of the investigation have been explained to them, and before screening assessments.
+18 more criteria

Exclusion Criteria

•The subject must be excluded from participating in the trial if the subject fulfil any single criteria described below:
•2\. The patient has an abnormal physical examination, abnormal laboratory test or electrocardiography results at the screening that are clinically significant to affect results of the research, as judged by the investigator.
•3\. If the patient has or is suspicious of having a hypersensitivity or allergy to \[18F\] THK-5351 or its derivatives.
•4\. The patient is pregnant, is attempting to become pregnant, or is nursing (breast-feeding) children.
•5\. The patient has a history of alcoholism or drug dependency/abuse within the last 2 years before screening.
•6\. The patient has contraindications to undergo PET or MRI, which include but are not restricted to the examples below: claustrophobia, cardiac pacemaker, metal devices around the eye or spinal cord, cochlear implant, etc.) at the screening visit.
•7\. The patient has been treated with any investigational medicinal product (IMP) within 30 days prior to the screening visit.
•8\. The patient has been tested positive for hepatitis B surface antigen (HBsAg), hepatitis C virus antibodies (anti-HCV), HIV Antibody, or syphilis serum test at the screening visit.
•9\. The patient has been receiving an anti-cholinergic drug in a regular basis within 3 months prior to the screening visit.
•10\. The patient has evidence of a clinically relevant neurological disorders other than the disease being studied (i.e., prodromal AD) at screening, including but not limited to: territorial cerebral infarction, intracranial hemorrhage, multiple sclerosis, neurosyphilis, mental retardation, hypoxic encephalopathy, major head trauma with loss of consciousness that led to persistent cognitive deficits.
+6 more criteria

Locations (1)

Asan Medical Center

Seoul, South Korea

Key Dates

Start Date

May 17, 2017

Primary Completion Date

August 31, 2018

Completion Date

August 31, 2018

Last Updated

December 14, 2020

Enrollment

ACTUAL participants

Conditions

Alzheimer Disease

Interventions

[18F]THK-5351

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 14, 2020Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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A Phase I [18F]THK-5351 Positron Emission Tomography Study in Healthy Subjects and Alzheimer's Disease

Inclusion Criteria

Exclusion Criteria

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