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

NCT03903211 | Completed Phase 2

• 1 other identifier: PI-18002
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 1

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.

Conditions

Cognitively Normal; Mild Cognitive Impairment; Alzheimer Disease

Keywords

[18F]PI-2620; tauopathy; positron emission computed tomography

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Changes of PI-2620 uptake over time measured by standard uptake value ratios (SUVR)

  60-90 minutes post injection

• Correlation between standard uptake value ratio (SUVR) of [18F]PI-2620 positron emission computed tomography and neuropsychiatric test scores

  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

  60-90 minutes post injection

Study Arms (3)

Cognitively normal individuals

EXPERIMENTAL

Cognitively normal individualswill receive a single IV injection of \[18F\]PI-2620.

Drug: [18F]PI-2620

Subjects with Mild Cognitive Impairment

EXPERIMENTAL

Subjects with Mild Cognitive Impairment will receive a single IV injection of \[18F\]PI-2620.

Drug: [18F]PI-2620

Subjects with Alzheimer Disease

EXPERIMENTAL

Alzheimer Disease Subjects with Alzheimer Disease will receive a single IV injection of \[18F\]PI-2620.

Drug: [18F]PI-2620

Interventions

[18F]PI-2620 DRUG

Imaging for evaluating the accumulation of abnormal tau protein in the brain

Also known as: FluoroTau

Cognitively normal individuals; Subjects with Alzheimer Disease; Subjects with Mild Cognitive Impairment

Eligibility Criteria

• Age: 40 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Cognitively normal individuals
• Subjects with Mild Cognitive Impairment
• Subjects with Alzheimer Disease

You may not qualify if:

• The subject must be excluded from participating in the trial if the subject fulfil any single criteria described below:
• 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.
• Cognitively normal individuals
• Subjects with Mild Cognitive Impairment
• Subjects with Alzheimer Disease

Sponsors & Collaborators

• Jae Seung Kim: lead

Study Sites (1)

Asan Medical Center

Seoul, 05505, South Korea

Location

MeSH Terms

Conditions

Cognitive Dysfunction; Alzheimer Disease; Tauopathies

Interventions

((18)F)PI-2620

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders; Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurodegenerative Diseases

Study Officials

• JAE SEUNG KIM, Professor

  Asan Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 1, 2019
• First Posted: April 4, 2019
• Study Start: April 9, 2019
• Primary Completion: February 28, 2021
• Study Completion: February 28, 2021
• Last Updated: September 6, 2023

Record last verified: 2023-09

Locations

KR (1)