Healthy VolunteerEarly Phase 1NCT03510572
Evaluation of [18F]PI-2620 as a Potential Positron Emission Computed Tomography Radioligand for Imaging Tau Protein in the Brain
A Early Phase 1 study testing [18F]PI-2620 in people with Healthy Volunteer and Alzheimer Disease, run by Asan Medical Center at 1 site in South Korea.
Trial 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). Read more about this study
- Who is it for?
- Ages 40 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteer, Alzheimer Disease, Frontotemporal Dementia
- What is being tested?
- [18F]PI-2620
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteSouth Korea
- Study dates
- 4 Jun 2018to 31 Jul 2019
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
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- 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
Who cannot join
- The subject must be excluded from participating in the trial if the subject fulfil any single criteria described below:
- 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.
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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).
- Being tested
- [18F]PI-2620
- Keywords
- [18F]PI-2620, tauopathy, positron emission computed tomography
- Medical subject headings
- Alzheimer Disease, Frontotemporal Dementia, Parkinson Disease, Tauopathies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
[18F]PI-2620Drug
Also called FluoroTau
Imaging for evaluating the accumulation of abnormal tau protein in the brain
| Study group | Role | What they receive |
|---|---|---|
| Healthy volunteer | Experimental | Cognitively healthy subjects will receive a single IV injection of [18F]PI-2620. Receives: Drug: [18F]PI-2620 |
| Alzheimer's Disease | Experimental | Alzheimer's Disease Subjects will receive a single IV injection of [18F]PI-2620. Receives: Drug: [18F]PI-2620 |
| Frontotemporal dementia | Experimental | frontotemporal dementia Subjects will receive a single IV injection of [18F]PI-2620. Receives: Drug: [18F]PI-2620 |
| Parkinson's disease | Experimental | Parkinson's disease Subjects will receive a single IV injection of [18F]PI-2620. Receives: Drug: [18F]PI-2620 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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
We will evaluate correlation between standard uptake value ratio (SUVR) [18F]PI-2620 positron emission computed tomography and scores of neuropsychiatric test
Measured: 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.
Measured: 60-90 minutes post injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2018
- Study start4 Jun 2018
- Primary completion31 Jul 2019
- Study completion31 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteerStudies of the same condition, open and under way.
- More trials run by Asan Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Asan Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Korea Health Industry Development Institute
- Responsible party
- Principal investigator, Jae Seung Kim, Asan Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03510572
- Sponsor's protocol ID
- PI-18001
- Status last verified
- Dec 2020
- First submitted
- 17 Apr 2018
- Last updated
- 14 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 14 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of [18F]PI-2620 Positron Emission Computed Tomography for Imaging Tau Protein in Patients With Tauopathies and Healthy Volunteers: Phase 0 Study
- ClinicalTrials.gov ID
- NCT03510572
- Acronym / sponsor ID
- PI-18001
- Keywords
- [18F]PI-2620, tauopathy, positron emission computed tomography
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Asan Medical CenterUniversity, hospital or other
- Collaborators
- Korea Health Industry Development Institute
- Study start
- 4 Jun 2018 (actual)
- Primary completion
- 31 Jul 2019 (actual)
- Study completion
- 31 Jul 2019 (actual)
- First posted
- 27 Apr 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Healthy volunteer | Experimental | Drug: [18F]PI-2620Cognitively healthy subjects will receive a single IV injection of [18F]PI-2620. |
| Alzheimer's Disease | Experimental | Drug: [18F]PI-2620Alzheimer's Disease Subjects will receive a single IV injection of [18F]PI-2620. |
| Frontotemporal dementia | Experimental | Drug: [18F]PI-2620frontotemporal dementia Subjects will receive a single IV injection of [18F]PI-2620. |
| Parkinson's disease | Experimental | Drug: [18F]PI-2620Parkinson's disease Subjects will receive a single IV injection of [18F]PI-2620. |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- General Subject Inclusion Criteria
- Cognitively Healthy Subjects
- Subjects with Alzheimer's disease
- Subjects with frontotemporal dementia
- Subjects with Parkinson's disease
Key exclusion criteria (13 listed)
- The subject must be excluded from participating in the trial if the subject fulfil any single criteria described below:
- General Exclusion Criteria
- Cognitively Healthy Subjects
- Subjects with Alzheimer's disease
- Subjects with frontotemporal dementia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| [18F]PI-2620Also: FluoroTauImaging for evaluating the accumulation of abnormal tau protein in the brain | Drug | Alzheimer's Disease, Frontotemporal dementia, Healthy volunteer, Parkinson's disease |
Primary outcome
Cross-sectional [18F]PI-2620 Imaging Results
Time frame: 60-90 minutes post injection
Compare Standard uptake value ratio (SUVR) and distribution of [18F]PI-2620 in subjects with tauopathies and cognitively healthy individuals.
.Assess the rate of change of tau deposition as measured by [18F]PI-2620 uptake (SUVR) over time
Time frame: 60-90 minutes post injection
Compare Standard uptake value ratio (SUVR) and distribution of [18F]PI-2620 in subjects with tauopathies and cognitively healthy individuals.
2 secondary outcomes
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 injection
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Dec 2020.
- Individual participant dataSharing planned: Undecided
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Screening Protocol
Pain
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing [18F]PI-2620 in people with Healthy Volunteer and Alzheimer Disease, run by Asan Medical Center at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cross-sectional [18F]PI-2620 Imaging Results (time frame: 60-90 minutes post injection). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Dec 2020.