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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

Sponsor
Jae Seung Kim (Other)
Overall Status
Recruiting
CT.gov ID
NCT03903211
Collaborator
(none)
72
Enrollment
2
Locations
3
Arms
22.7
Anticipated Duration (Months)
36
Patients Per Site
1.6
Patients Per Site Per Month

Study Details

Study Description

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
Phase 2

Study Design

Study Type:
Interventional
Anticipated 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 :
Apr 9, 2019
Anticipated Primary Completion Date :
Feb 28, 2021
Anticipated Study Completion Date :
Feb 28, 2021

Arms and Interventions

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 Names:
  • 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 Names:
  • 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 Names:
  • FluoroTau

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Cross-sectional PI-2620 uptake measured by standard uptake value ratio (SUVR) [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) [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 [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 [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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    40 Years to 85 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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.

    1. Cognitively normal individuals

    2. Subjects with Mild Cognitive Impairment

    3. 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.

    1. Cognitively normal individuals

    2. Subjects with Mild Cognitive Impairment

    3. Subjects with Alzheimer Disease

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Asan Medical Center Seoul Korea, Republic of 05505
    2 Samsung Medical Center Seoul Korea, Republic of

    Sponsors and Collaborators

    • Jae Seung Kim

    Investigators

    • Principal Investigator: JAE SEUNG KIM, Professor, Asan Medical Center

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Jae Seung Kim, Principal Investigator, Asan Medical Center
    ClinicalTrials.gov Identifier:
    NCT03903211
    Other Study ID Numbers:
    • PI-18002
    First Posted:
    Apr 4, 2019
    Last Update Posted:
    Dec 14, 2020
    Last Verified:
    Dec 1, 2020
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Jae Seung Kim, Principal Investigator, Asan Medical Center
    [18F]PI-2620
    tauopathy
    positron emission computed tomography
    Additional relevant MeSH terms:
    Alzheimer Disease
    Cognitive Dysfunction

    Study Results

    No Results Posted as of Dec 14, 2020