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

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: Completed
• Conditions: Alzheimer Disease; Mild Cognitive Impairment; Cognitively Normal
• Intervention / Treatment: Drug: [18F]PI-2620

• Study Type: Interventional
• Enrollment (Actual): 84
• Phase: Phase 2

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 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

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cross-sectional PI-2620 uptake measured by standard uptake value ratio (SUVR)	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

Outcome Measure	Measure Description	Time Frame
Changes of PI-2620 uptake over time measured by standard uptake value ratios (SUVR)	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	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	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

• Sponsor: Jae Seung Kim
• Investigators: Principal Investigator: JAE SEUNG KIM, Professor, Asan Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): April 9, 2019
• Primary Completion (Actual): February 28, 2021
• Study Completion (Actual): February 28, 2021

Study Registration Dates

• First Submitted: April 1, 2019
• First Submitted That Met QC Criteria: April 3, 2019
• First Posted (Actual): April 4, 2019

Study Record Updates

• Last Update Posted (Actual): September 6, 2023
• Last Update Submitted That Met QC Criteria: September 1, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Keywords: tauopathy; [18F]PI-2620; positron emission computed tomography
• Additional Relevant MeSH Terms: Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Neurodegenerative Diseases; Dementia; Tauopathies; Cognition Disorders; Alzheimer Disease; Cognitive Dysfunction
• Other Study ID 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