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Longitudinal Changes of [18F]PI-2620 Positron Emission Tomography in Subjects With Cognitively Normal, Mild Cognitive Impairment and Alzheimer's Disease

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ClinicalTrials.gov Identifier: NCT03903211
Recruitment Status : Recruiting
First Posted : April 4, 2019
Last Update Posted : May 31, 2019
Sponsor:
Information provided by (Responsible Party):
Jae Seung Kim, Asan Medical Center

Brief Summary:
The overall goal of this imaging trial is to evaluate crosssectional difference and longitudinal changes of [18F]PI-2620, a tau targeted positron emission computed tomography radioligand, in cognitively normal individuals, and subjects with mild cognitive impairment and Alzheimer's disease.

Condition or disease Intervention/treatment Phase
Cognitively Normal Mild Cognitive Impairment Alzheimer Disease Drug: [18F]PI-2620 Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 72 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Longitudinal Changes of [18F]PI-2620 Positron Emission Tomography in Subjectives With Cognitively Normal, Mild Cognitive Impairment and Alzheimer's Disease
Actual Study Start Date : April 9, 2019
Estimated Primary Completion Date : February 28, 2021
Estimated Study Completion Date : February 28, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Cognitively normal individuals
Cognitively normal individualswill 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: Subjects with Mild Cognitive Impairment
Subjects with Mild Cognitive Impairment 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: Subjects with Alzheimer Disease
Alzheimer Disease Subjects with Alzheimer Disease 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 PI-2620 uptake measured by standard uptake value ratio (SUVR) [ Time Frame: 0-90 minutes post injection ]
    Cross-sectional PI-2620 uptake measured by standard uptake value ratio (SUVR) in Cognitively normal, Mild Cognitive Impairment and Alzheimer Disease.


Secondary Outcome Measures :
  1. Changes of PI-2620 uptake over time measured by standard uptake value ratios (SUVR) [ Time Frame: 0-90 minutes post injection ]
    Changes of PI-2620 uptake over time measured by standard uptake value ratios (SUVR) in Cognitively normal, Mild Cognitive Impairment and Alzheimer Disease.

  2. Correlation between standard uptake value ratio (SUVR) of [18F]PI-2620 positron emission computed tomography and neuropsychiatric test scores [ Time Frame: 0-90 minutes post-injectio ]
    We will evaluate correlation between standard uptake value ratio (SUVR) [18F]PI-2620 positron emission computed tomography and scores of neuropsychiatric test

  3. Correlation between standard uptake value ratio (SUVR) of [18F]PI-2620 positron emission computed tomography and indices of structural MRI [ Time Frame: 0-90 minutes post injection ]
    We will evaluate correlation between standard uptake value ratio (SUVR) [18F]PI-2620 positron emission computed tomography and indices of structural Magnetic Resonance Imaging including cortical thickness, hippocampal atrophy.



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Ages Eligible for Study:   40 Years to 85 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 < 85 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 normal individuals
  3. Subjects with Mild Cognitive Impairment
  4. Subjects with Alzheimer 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 1 years prior to the screening visit.
  2. Cognitively normal individuals
  3. Subjects with Mild Cognitive Impairment
  4. Subjects with Alzheimer 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): NCT03903211


Contacts
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Contact: JAE EUN KIM, PM +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: Minyoung Oh, MD         
Samsung Medical Center Not yet 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
Investigators
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Principal Investigator: JAE SEUNG KIM, Professor Asan Medical Center
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Responsible Party: Jae Seung Kim, Principal Investigator, Asan Medical Center
ClinicalTrials.gov Identifier: NCT03903211    
Other Study ID Numbers: PI-18002
First Posted: April 4, 2019    Key Record Dates
Last Update Posted: May 31, 2019
Last Verified: May 2019
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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Alzheimer Disease
Cognitive Dysfunction
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders
Cognition Disorders