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[18F]THK-5351 Positron Emission Computed Tomography Study of Normal, Mild Cognitive Impairment, Alzheimer's Disease and Other Neurodegenerative Disease

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ClinicalTrials.gov Identifier: NCT02656498
Recruitment Status : Recruiting
First Posted : January 15, 2016
Last Update Posted : April 19, 2018
Sponsor:
Collaborators:
Korea Health Industry Development Institute
Samsung Medical Center
Information provided by (Responsible Party):
Jae Seung Kim, Asan Medical Center

Brief Summary:
This is a cross-sectional and longitudinal study to evaluate the clinical utility of [18F]THK-5351 positron emission computed tomography in cognitively healthy volunteers, mild cognitive impairment (MCI), Alzheimer's disease (AD) and other neurodegenerative patients.

Condition or disease Intervention/treatment Phase
Alzheimer's Disease Mild Cognitive Impairment Neurodegenerative Diseases Drug: [18F]THK-5351 Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 180 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: An Open Label, Multicenter Study for Evaluation of the Clinical Utility of [18F]THK-5351 Positron Emission Computed Tomography in Cognitively Healthy Volunteers, Subjects With Mild Cognitive Impairment, Subjects With Alzheimer's Disease and Subjects With Other Neurodegenerative Diseases
Actual Study Start Date : January 2016
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2019


Arm Intervention/treatment
Experimental: Cognitively Healthy Subjects
Cognitively healthy subjects will receive an IV injection, [18F]THK-5351 at baseline and also receive an IV injection, [18F]THK-5351 at 24 months.
Drug: [18F]THK-5351
Imaging for evaluating the accumulation of abnormal tau protein in the brain
Other Name: FluoroTau

Experimental: MCI Subjects
MCI Subjects will receive an IV injection, [18F]THK-5351 at baseline and also receive an IV injection, [18F]THK-5351 at 24 months.
Drug: [18F]THK-5351
Imaging for evaluating the accumulation of abnormal tau protein in the brain
Other Name: FluoroTau

Experimental: AD Subjects
AD Subjects will receive an IV injection, [18F]THK-5351 at baseline and also receive an IV injection, [18F]THK-5351 at 24 months.
Drug: [18F]THK-5351
Imaging for evaluating the accumulation of abnormal tau protein in the brain
Other Name: FluoroTau

Experimental: Subjects with other neurodegenerative disease
Subjects with other neurodegenerative disease will receive an IV injection, [18F]THK-5351 at baseline.
Drug: [18F]THK-5351
Imaging for evaluating the accumulation of abnormal tau protein in the brain
Other Name: FluoroTau




Primary Outcome Measures :
  1. Cross-sectional [18F]THK-5351 Imaging Results [ Time Frame: 50-70 minutes post injection ]
    Compare Standard uptake value ratio (SUVR) and distribution of [18F]THK-5351 in subjects with MCI, subjects with AD, subjects with other neurodegenerative disease and cognitively healthy individuals.

  2. Assess the rate of change of tau deposition as measured by [18F]THK-5351 uptake (SUVR) over time [ Time Frame: 24 months ]
    Compare Standard uptake value ratio (SUVR) and distribution of [18F]THK-5351 in subjects with MCI, subjects with AD, subjects with other neurodegenerative disease and cognitively healthy individuals.


Secondary Outcome Measures :
  1. Correlation between standard uptake value ratio (SUVR) of [18F]THK-5351 positron emission computed tomography and neuropsychiatric test scores [ Time Frame: 50-70 minutes post-injection ]
    We will evaluate correlation between standard uptake value ratio (SUVR) [18F]THK-5351 positron emission computed tomography and scores of neuropsychiatric test

  2. Correlation between standard uptake value ratio (SUVR) of [18F]THK-5351 positron emission computed tomography and indices of structural MRI [ Time Frame: 50-70 minutes post-injection ]
    We will evaluate correlation between standard uptake value ratio (SUVR) [18F]THK-5351 positron emission computed tomography and indices of structural MRI including cortical thickness, hippocampal atrophy.

  3. Correlation between standard uptake value ratio (SUVR) of [18F]THK-5351 positron emission computed tomography and indices of functional MRI [ Time Frame: 50-70 minutes post-injection ]
    We will evaluate correlation between standard uptake value ratio (SUVR) [18F]THK-5351 positron emission computed tomography and indices of functional MRI derived from diffusion tensor imaging and resting state functional MRI.

  4. Correlation between standard uptake value ratios (SUVR) and distribution of [18F]THK-5351 positron emission computed tomography and amyloid positron emission computed tomography [ Time Frame: 50-70 minutes post-injection ]
    We will evaluate correlation between standard uptake value ratio (SUVR) and distribution of [18F]THK-5351 positron emission computed tomography and those of amyloid positron emission computed tomography



Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. General Subject Inclusion Criteria

    In order to be eligible for participation in this trial, the subject must:

    • Be ≥ 40 and < 80 years of age at the Screening Visit.
    • 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.)
    • 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.
    • Have results of clinical laboratory tests/physical examination, vital signs, and ECG within normal limits (at 90 days prior to [18F]THK-5351 positron emission computed tomography) or clinically acceptable to the investigator at screening.
    • 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.
    • If female, not be of childbearing potential as indicated by one of the following
    • 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.
    • Each subject must be willing to provided blood samples for genotyping apolipoprotein E
  2. Cognitively Healthy Subjects
  3. MCI Subjects
  4. AD Subjects
  5. Subjects with other neurodegenerative disease

Exclusion Criteria

The subject must be excluded from participating in the trial if the subject fulfil any single criteria described below:

1. General Exclusion Criteria

  • Based on the investigators' judgement, if the patient is not capable of communicating with the site personnel, if the patient is not proficient in the language in which the psychometric tests will be completed, or if the patient is not sufficient for compliance with the study procedures.
  • The patient has an abnormal physical examination or abnormal laboratory test results at the screening that are clinically significant to affect results of the research, as judged by the investigator.
  • If the patient has or is suspicious of having a hypersensitivity or allergy to [18F] THK-5351 or its derivatives.
  • The patient is pregnant, is attempting to become pregnant, or is nursing (breast-feeding) children.
  • The patient has a history of alcoholism or drug dependency/abuse within the last 2 years before screening.
  • The patient has contraindications to undergo positron emission computed tomography 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.
  • The patient has been treated with any investigational medicinal product (IMP) within 30 days prior to the screening visit.
  • 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.
  • The patient has been receiving an anti-cholinergic drug in a regular basis within 3 months prior to the screening visit.
  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02656498


Contacts
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Contact: Minyoung Oh, M.D.,Ph.D. +82-2-3010-1447 my@amc.seoul.kr
Contact: JaeEun Kim, RN +82-2-3010-4572 kje0216@amc.seoul.kr

Locations
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Korea, Republic of
Asan Medical Center Recruiting
Seoul, Korea, Republic of, 05505
Contact: Jae Seung Kim, MD    +82-2-3010-4594    jaeskim@amc.seoul.kr   
Principal Investigator: Jae Seung Kim, MD         
Sub-Investigator: Jee Hoon Roh, MD         
Sub-Investigator: Jae Hong Lee, MD         
Sub-Investigator: Seung Jun Oh, PhD         
Sub-Investigator: Jihye Hwang, MD         
Sub-Investigator: Minyoung Oh, MD         
Samsung Medical Center Recruiting
Seoul, Korea, Republic of
Contact: Sang Won Seo, MD       sangwonseo@empas.com   
Principal Investigator: Sang Won Seo, MD         
Sponsors and Collaborators
Jae Seung Kim
Korea Health Industry Development Institute
Samsung Medical Center
Investigators
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Principal Investigator: Jae Seung Kim, M.D.,Ph.D. Asan Medical Center

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Responsible Party: Jae Seung Kim, Professor, Asan Medical Center
ClinicalTrials.gov Identifier: NCT02656498     History of Changes
Other Study ID Numbers: THK-15002
First Posted: January 15, 2016    Key Record Dates
Last Update Posted: April 19, 2018
Last Verified: April 2018

Keywords provided by Jae Seung Kim, Asan Medical Center:
Tau, neurodegeneration, positron emission computed tomography

Additional relevant MeSH terms:
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Alzheimer Disease
Neurodegenerative Diseases
Cognitive Dysfunction
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurocognitive Disorders
Mental Disorders
Cognition Disorders