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

NCT03510572 | Completed Early Phase 1

• 1 other identifier: PI-18001
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Healthy Volunteer; Alzheimer Disease; Frontotemporal Dementia; Parkinson Disease

Keywords

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

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

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

  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

  60-90 minutes post injection

Study Arms (4)

Healthy volunteer

EXPERIMENTAL

Cognitively healthy subjects will receive a single IV injection of \[18F\]PI-2620.

Drug: [18F]PI-2620

Alzheimer's Disease

EXPERIMENTAL

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

Drug: [18F]PI-2620

Frontotemporal dementia

EXPERIMENTAL

frontotemporal dementia Subjects will receive a single IV injection of \[18F\]PI-2620.

Drug: [18F]PI-2620

Parkinson's disease

EXPERIMENTAL

Parkinson's disease Subjects 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

Alzheimer's Disease; Frontotemporal dementia; Healthy volunteer; Parkinson's disease

Eligibility Criteria

• Age: 40 Years - 80 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 \< 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.
• Cognitively Healthy Subjects
• Subjects with Alzheimer's disease
• Subjects with frontotemporal dementia
• Subjects with Parkinson's 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 30 days prior to the screening visit.
• Cognitively Healthy Subjects
• Subjects with Alzheimer's disease
• Subjects with frontotemporal dementia
• Subjects with Parkinson's disease

Sponsors & Collaborators

• Asan Medical Center: lead
• Korea Health Industry Development Institute: collaborator

Study Sites (1)

Asan Medical Center

Seoul, 05505, South Korea

Location

MeSH Terms

Conditions

Alzheimer Disease; Frontotemporal Dementia; Parkinson Disease; Tauopathies

Interventions

((18)F)PI-2620

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders; Frontotemporal Lobar Degeneration; TDP-43 Proteinopathies; Proteostasis Deficiencies; Metabolic Diseases; Nutritional and Metabolic Diseases; Parkinsonian Disorders; Basal Ganglia Diseases; Movement Disorders; Synucleinopathies

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: April 17, 2018
• First Posted: April 27, 2018
• Study Start: June 4, 2018
• Primary Completion: July 31, 2019
• Study Completion: July 31, 2019
• Last Updated: December 14, 2020

Record last verified: 2020-12

Locations

KR (1)