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

September 1, 2023 updated by: Jae Seung Kim

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
84

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

40 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Cross-sectional PI-2620 uptake measured by standard uptake value ratio (SUVR)
Time Frame: 60-90 minutes post injection
Cross-sectional PI-2620 uptake measured by standard uptake value ratio (SUVR) in Cognitively normal, Mild Cognitive Impairment and Alzheimer Disease.
60-90 minutes post injection

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Changes of PI-2620 uptake over time measured by standard uptake value ratios (SUVR)
Time Frame: 60-90 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.
60-90 minutes post injection
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-injectio
We will evaluate correlation between standard uptake value ratio (SUVR) [18F]PI-2620 positron emission computed tomography and scores of neuropsychiatric test
60-90 minutes post-injectio
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 Magnetic Resonance Imaging including cortical volume, hippocampal atrophy.
60-90 minutes post injection

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Jae Seung Kim

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: JAE SEUNG KIM, Professor, Asan Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 9, 2019

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 28, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 28, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 1, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 3, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 4, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 6, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 1, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • PI-18002

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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