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Evaluation of [18F]PI-2620 as a Potential Positron Emission Computed Tomography Radioligand for Imaging Tau Protein in the Brain

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03510572
Recruitment Status : Recruiting
First Posted : April 27, 2018
Last Update Posted : October 15, 2018
Sponsor:
Collaborator:
Korea Health Industry Development Institute
Information provided by (Responsible Party):
Jae Seung Kim, Asan Medical Center

Brief Summary:
The overall goal of this imaging trial is to evaluate [18F]PI-2620, a tau targeted positron emission computed tomography radioligand, in individuals with tauopathies and healthy volunteers (HV).

Condition or disease Intervention/treatment Phase
Healthy Volunteer Alzheimer Disease Frontotemporal Dementia Parkinson Disease Drug: [18F]PI-2620 Early Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Clinical Evaluation of [18F]PI-2620 Positron Emission Computed Tomography for Imaging Tau Protein in Patients With Tauopathies and Healthy Volunteers: Phase 0 Study
Actual Study Start Date : June 4, 2018
Estimated Primary Completion Date : July 2019
Estimated Study Completion Date : July 2019


Arm Intervention/treatment
Experimental: Healthy volunteer
Cognitively healthy subjects will receive a single IV injection of [18F]PI-2620.
Drug: [18F]PI-2620
Imaging for evaluating the accumulation of abnormal tau protein in the brain
Other Name: FluoroTau

Experimental: Alzheimer's Disease
Alzheimer's Disease Subjects will receive a single IV injection of [18F]PI-2620.
Drug: [18F]PI-2620
Imaging for evaluating the accumulation of abnormal tau protein in the brain
Other Name: FluoroTau

Experimental: Frontotemporal dementia
frontotemporal dementia Subjects will receive a single IV injection of [18F]PI-2620.
Drug: [18F]PI-2620
Imaging for evaluating the accumulation of abnormal tau protein in the brain
Other Name: FluoroTau

Experimental: Parkinson's disease
Parkinson's disease Subjects will receive a single IV injection of [18F]PI-2620.
Drug: [18F]PI-2620
Imaging for evaluating the accumulation of abnormal tau protein in the brain
Other Name: FluoroTau




Primary Outcome Measures :
  1. Cross-sectional [18F]PI-2620 Imaging Results [ Time Frame: 60-90 minutes post injection ]
    Compare Standard uptake value ratio (SUVR) and distribution of [18F]PI-2620 in subjects with tauopathies and cognitively healthy individuals.

  2. .Assess the rate of change of tau deposition as measured by [18F]PI-2620 uptake (SUVR) over time [ Time Frame: 60-90 minutes post injection ]
    Compare Standard uptake value ratio (SUVR) and distribution of [18F]PI-2620 in subjects with tauopathies and cognitively healthy individuals.


Secondary Outcome Measures :
  1. Correlation between standard uptake value ratio (SUVR) of [18F]PI-2620 positron emission computed tomography and neuropsychiatric test scores [ Time Frame: 60-90 minutes post injection ]
    We will evaluate correlation between standard uptake value ratio (SUVR) [18F]PI-2620 positron emission computed tomography and scores of neuropsychiatric test

  2. Correlation between standard uptake value ratio (SUVR) of [18F]PI-2620 positron emission computed tomography and indices of structural MRI [ Time Frame: 60-90 minutes post injection ]
    We will evaluate correlation between standard uptake value ratio (SUVR) [18F]PI-2620 positron emission computed tomography and indices of structural MRI including cortical thickness, hippocampal atrophy.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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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]PI-2620 positron emission computed tomography) or clinically acceptable to the investigator at screening.
    • 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.
  2. Cognitively Healthy Subjects
  3. Subjects with Alzheimer's disease
  4. Subjects with frontotemporal dementia
  5. Subjects with Parkinson's 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] PI-2620 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.
  2. Cognitively Healthy Subjects
  3. Subjects with Alzheimer's disease
  4. Subjects with frontotemporal dementia
  5. Subjects with Parkinson's disease

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): NCT03510572


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: Minyoung Oh, MD         
Sponsors and Collaborators
Asan Medical Center
Korea Health Industry Development Institute
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Responsible Party: Jae Seung Kim, Professor, Asan Medical Center
ClinicalTrials.gov Identifier: NCT03510572    
Other Study ID Numbers: PI-18001
First Posted: April 27, 2018    Key Record Dates
Last Update Posted: October 15, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Jae Seung Kim, Asan Medical Center:
[18F]PI-2620, tauopathy, positron emission computed tomography
Additional relevant MeSH terms:
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Parkinson Disease
Alzheimer Disease
Frontotemporal Dementia
Aphasia, Primary Progressive
Pick Disease of the Brain
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
Dementia
Tauopathies
Neurocognitive Disorders
Mental Disorders
Frontotemporal Lobar Degeneration
TDP-43 Proteinopathies
Proteostasis Deficiencies
Metabolic Diseases
Aphasia
Speech Disorders
Language Disorders
Communication Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Signs and Symptoms