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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

Tracking Information
First Submitted Date  ICMJE January 12, 2016
First Posted Date  ICMJE January 15, 2016
Last Update Posted Date April 19, 2018
Actual Study Start Date  ICMJE January 2016
Estimated Primary Completion Date December 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 13, 2016)
  • 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.
  • 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.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02656498 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: January 13, 2016)
  • 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
  • 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.
  • 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.
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE [18F]THK-5351 Positron Emission Computed Tomography Study of Normal, Mild Cognitive Impairment, Alzheimer's Disease and Other Neurodegenerative Disease
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE
  • Alzheimer's Disease
  • Mild Cognitive Impairment
  • Neurodegenerative Diseases
Intervention  ICMJE Drug: [18F]THK-5351
Imaging for evaluating the accumulation of abnormal tau protein in the brain
Other Name: FluoroTau
Study Arms  ICMJE
  • 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.
    Intervention: Drug: [18F]THK-5351
  • 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.
    Intervention: Drug: [18F]THK-5351
  • 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.
    Intervention: Drug: [18F]THK-5351
  • Experimental: Subjects with other neurodegenerative disease
    Subjects with other neurodegenerative disease will receive an IV injection, [18F]THK-5351 at baseline.
    Intervention: Drug: [18F]THK-5351
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: January 13, 2016)
180
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2019
Estimated Primary Completion Date December 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 40 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
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
Listed Location Countries  ICMJE Korea, Republic of
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02656498
Other Study ID Numbers  ICMJE THK-15002
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Jae Seung Kim, Asan Medical Center
Study Sponsor  ICMJE Jae Seung Kim
Collaborators  ICMJE
  • Korea Health Industry Development Institute
  • Samsung Medical Center
Investigators  ICMJE
Principal Investigator: Jae Seung Kim, M.D.,Ph.D. Asan Medical Center
PRS Account Asan Medical Center
Verification Date April 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP