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

Clinical Evaluation of [18F]PI-2620 Positron Emission Computed Tomography for Imaging Tau Protein in Patients With Tauopathies and Healthy Volunteers: Phase 0 Study

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).

Study Overview

• Status: Completed
• Conditions: Parkinson Disease; Alzheimer Disease; Healthy Volunteer; Frontotemporal Dementia
• Intervention / Treatment: Drug: [18F]PI-2620

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Early Phase 1

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 05505
    • Asan Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

4

Arms and Interventions

Participant Group / 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 Names: 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 Names: 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 Names: 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 Names: FluoroTau

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Correlation between standard uptake value ratio (SUVR) of [18F]PI-2620 positron emission computed tomography and neuropsychiatric test scores	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 injection
Correlation between standard uptake value ratio (SUVR) of [18F]PI-2620 positron emission computed tomography and indices of structural MRI	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.	60-90 minutes post injection

Collaborators and Investigators

• Sponsor: Asan Medical Center
• Collaborators: Korea Health Industry Development Institute

Study record dates

Study Major Dates

• Study Start (Actual): June 4, 2018
• Primary Completion (Actual): July 31, 2019
• Study Completion (Actual): July 31, 2019

Study Registration Dates

• First Submitted: April 17, 2018
• First Submitted That Met QC Criteria: April 17, 2018
• First Posted (Actual): April 27, 2018

Study Record Updates

• Last Update Posted (Actual): December 14, 2020
• Last Update Submitted That Met QC Criteria: December 11, 2020
• Last Verified: December 1, 2020

More Information

Terms related to this study

• Keywords: [18F]PI-2620, tauopathy, positron emission computed tomography
• Additional Relevant MeSH Terms: Mental Disorders; Metabolic Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Neurobehavioral Manifestations; Neurocognitive Disorders; Parkinsonian Disorders; Basal Ganglia Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; TDP-43 Proteinopathies; Proteostasis Deficiencies; Dementia; Tauopathies; Language Disorders; Communication Disorders; Speech Disorders; Frontotemporal Lobar Degeneration; Aphasia; Parkinson Disease; Alzheimer Disease; Frontotemporal Dementia; Aphasia, Primary Progressive; Pick Disease of the Brain
• Other Study ID Numbers: PI-18001

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