Cognitively NormalPhase 2NCT03903211
Longitudinal Changes of [18F]PI-2620 Positron Emission Tomography in Subjects With Cognitively Normal, Mild Cognitive Impairment and Alzheimer's Disease
A Phase 2 study testing [18F]PI-2620 in people with Cognitively Normal and Mild Cognitive Impairment, run by Jae Seung Kim at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Cognitively Normal, Mild Cognitive Impairment, Alzheimer Disease
- 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
- 84 participants
- Where
- 1 siteSouth Korea
- Study dates
- 9 Apr 2019to 28 Feb 2021
- Phase
- Phase 2
- 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 85 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 < 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.
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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 normal individuals
- Subjects with Mild Cognitive Impairment
- Subjects with Alzheimer 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 1 years prior to the screening visit.
- Cognitively normal individuals
- Subjects with Mild Cognitive Impairment
- Subjects with Alzheimer Disease
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Being tested
- [18F]PI-2620
- Keywords
- [18F]PI-2620, tauopathy, positron emission computed tomography
- Medical subject headings
- Cognitive Dysfunction, Alzheimer 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 |
|---|---|---|
| Cognitively normal individuals | Experimental | Cognitively normal individualswill receive a single IV injection of [18F]PI-2620. Receives: 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. Receives: 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. Receives: Drug: [18F]PI-2620 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 60-90 minutes post injection
Secondary outcomes (3)
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.
Measured: 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
Measured: 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.
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 posted4 Apr 2019
- Study start9 Apr 2019
- Primary completion28 Feb 2021
- Study completion28 Feb 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cognitively NormalStudies of the same condition, open and under way.
- 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
- Phase 2
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jae Seung Kim
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Jae Seung Kim, Asan Medical Center
- Investigators
- JAE SEUNG KIM, Professor, Principal investigator, Asan Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03903211
- Sponsor's protocol ID
- PI-18002
- Status last verified
- Sep 2023
- First submitted
- 1 Apr 2019
- Last updated
- 6 Sep 2023
- 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 6 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Longitudinal Changes of [18F]PI-2620 Positron Emission Tomography in Subjectives With Cognitively Normal, Mild Cognitive Impairment and Alzheimer's Disease
- ClinicalTrials.gov ID
- NCT03903211
- Acronym / sponsor ID
- PI-18002
- Keywords
- [18F]PI-2620, tauopathy, positron emission computed tomography
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- Jae Seung KimUniversity, hospital or other
- Study start
- 9 Apr 2019 (actual)
- Primary completion
- 28 Feb 2021 (actual)
- Study completion
- 28 Feb 2021 (actual)
- First posted
- 4 Apr 2019 (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 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 design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Cognitively normal individuals | Experimental | Drug: [18F]PI-2620Cognitively normal individualswill receive a single IV injection of [18F]PI-2620. |
| Subjects with Mild Cognitive Impairment | Experimental | Drug: [18F]PI-2620Subjects with Mild Cognitive Impairment will receive a single IV injection of [18F]PI-2620. |
| Subjects with Alzheimer Disease | Experimental | Drug: [18F]PI-2620Alzheimer Disease Subjects with Alzheimer Disease will receive a single IV injection of [18F]PI-2620. |
Who may qualify
- Ages
- 40 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- General Subject Inclusion Criteria
- Cognitively normal individuals
- Subjects with Mild Cognitive Impairment
- Subjects with Alzheimer Disease
Key exclusion criteria (12 listed)
- The subject must be excluded from participating in the trial if the subject fulfil any single criteria described below:
- General Exclusion Criteria
- Cognitively normal individuals
- Subjects with Mild Cognitive Impairment
- Subjects with Alzheimer Disease
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 | Cognitively normal individuals, Subjects with Alzheimer Disease, Subjects with Mild Cognitive Impairment |
Primary outcome
Cross-sectional PI-2620 uptake measured by standard uptake value ratio (SUVR)
Time frame: 60-90 minutes post injection
Cross-sectional PI-2620 uptake measured by standard uptake value ratio (SUVR) in Cognitively normal, Mild Cognitive Impairment and Alzheimer Disease.
3 secondary outcomes
Changes of PI-2620 uptake over time measured by standard uptake value ratios (SUVR)
Time frame: 60-90 minutes post injection
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-injectio
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 6 Sep 2023.
- Individual participant dataSharing planned: Undecided
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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.
JAE SEUNG KIM, Professor principal investigator
Asan Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing [18F]PI-2620 in people with Cognitively Normal and Mild Cognitive Impairment, run by Jae Seung Kim 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 11 inclusion and 12 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 6 Sep 2023. 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?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 PI-2620 uptake measured by standard uptake value ratio (SUVR) (time frame: 60-90 minutes post injection). 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 6 Sep 2023.