Progressive Supranuclear PalsyPhase 1NCT05005819
Evaluation of [18F]APN-1607 as a PET Biomarker
A Phase 1 study testing [18F] APN-1607 in people with Progressive Supranuclear Palsy and Healthy Volunteers, run by Invicro at 1 site in United States.
Trial summary
The overall goal of this protocol is to evaluate [18F]APN-1607 as a PET radiotracer for measuring longitudinal change in tau pathology in participants with PSP. Read more about this study
- Who is it for?
- Ages 50 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Progressive Supranuclear Palsy, Healthy Volunteers
- What is being tested?
- [18F] APN-1607
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- 25 May 2021to 9 Jan 2024
- Phase
- 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 50 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Males or females from 50 to 80 years of age at Screening, inclusive.
- Body weight range of ≥ 43 kg to ≤ 120 kg.
- Score ≥20 on the MMSE at Screening.
- For women of childbearing potential, agreement to remain abstinent (refrain from heterosexual intercourse) or use contraception, and agreement to refrain from donating eggs, as defined below:
- A woman is considered to be of childbearing potential if she is postmenarchal, has not reached a postmenopausal state (12 continuous months of amenorrhea with no identified cause other than menopause), and is not permanently infertile due to surgery (ie, removal of ovaries, fallopian tubes, and/or uterus) or another cause as determined by the Investigator (eg, Müllerian agenesis). The definition of childbearing potential may be adapted for alignment with local guidelines or regulations.
- Women of childbearing potential must remain abstinent or use 2 methods of contraception, one of which is a barrier method (ie, male or female condom), for the study duration and 30 days after the last dose.
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- Male participants with partners of childbearing potential must commit to the use of 2 methods of contraception, one of which is a barrier method (ie, male condom with or without spermicidal jelly), for the study duration and 90 days after the last dose.
- Male participants must not donate sperm for the duration of the study and 90 days after the last dose.
- For participants receiving arterial cannulation, adequate circulation to the hand for safe placement of arterial line (as determined by Allen's test) and blood clotting (prothrombin time and partial thromboplastin time [PT \& PTT]).
- Additional Inclusion Criteria for HVs
- Understand the study procedures and agree to participate by providing written informed consent.
- Healthy with no clinically relevant finding on physical examination at Screening.
- No cognitive impairment based on neuropsychological testing, as judged by the Investigator.
- No family history of neurological disease associated with dementia.
- Additional Inclusion Criteria for Participants with PSP
- Agree to participate by providing written informed consent or written assent with informed consent from the participant's LAR or caregiver.
- Has a clinical diagnosis of probable PSP based on the National Institute of Neurological Disorders and Stroke and the Society for PSP (NINDS-SPSP) criteria (Litvan, et al 1996).
- Have Screening or prior DaTscan SPECT imaging demonstrating evidence of DaT deficit, based on visual read.
- A brain MRI scan that supports a diagnosis of PSP, with no other evidence of significant neurologic pathology.
- Deemed by the opinion of the Principal Investigator to be physically able to participate in all visits throughout the duration of the trial.
- Medications taken for symptomatic treatment of PSP should be maintained on a stable dosage regimen for at least 30 days before Screening, if possible.
- The participant has an appropriate caregiver capable of accompanying participant, if applicable.
Who cannot join
- Participants are only eligible if they do not fulfill any of the exclusion criteria for the participant group.
- Current or prior history (in the last 12 months) of any alcohol or drug abuse.
- Laboratory tests with clinically significant abnormalities and/or clinically significant unstable medical illness.
- Participants with QT interval corrected for heart rate using Fridericia's formula (QTcF) >450 msec (males) or >470 msec (females) at Screening will be excluded. ECG measurements may be repeated once.
- Has received an investigational drug or device within 30 days of Screening.
- Prior participation in other research protocols or clinical care in the last year in addition to the radiation exposure expected from participation in this clinical study, such that radiation exposure exceeds the effective dose of 50 mSv, which would be above the acceptable annual limit established by the US Federal Guidelines.
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- Pregnancy, lactating or breastfeeding.
- Evidence of clinically significant gastrointestinal, cardiovascular, hepatic, renal, hematological, neoplastic, endocrine, alternative neurological, immunodeficiency, pulmonary, or other disorder or disease.
- Unsuitable veins for repeated venipuncture or contraindication to arterial blood sampling (for participants who will receive arterial blood sampling).
- MRI exclusion criteria include: Findings that may be responsible for the neurologic status of the participant such as significant evidence of cerebrovascular disease (more than 2 lacunar infarcts, any territorial infarct >1 cm3, or deep white matter abnormality corresponding to an overall Fazekas scale of 3 with at least one confluent hyperintense lesion on the fluid-attenuated inversion recovery (FLAIR) sequence that is ≥20 mm in any dimension), infectious disease, space-occupying lesions, normal pressure hydrocephalus or any other abnormalities associated with central nervous system (CNS) disease (other than findings consistent with PSP for participants with PSP).
- Implants such as implanted cardiac pacemakers or defibrillators, insulin pumps, cochlear implants, metallic ocular foreign body, implanted neural stimulators, CNS aneurysm clips and other medical implants that have not been certified for MRI, or history of claustrophobia in MRI.
- Use of over the counter (OTC) medication (except acetaminophen), dietary supplements, or vitamins, within 2 weeks prior to initial dosing, unless approved by the Investigator.
- Has a known hypersensitivity to any component of the formulation of [18F]APN-1607 or related compounds.
- Major surgery, or donation or loss of 400 mL or more of blood within 4 weeks prior to initial dosing, or longer, if required by local regulation.
- History of immunodeficiency diseases, including a positive HIV test result.
- A positive Hepatitis B surface antigen (HBsAg) or Hepatitis C antibody test result.
- Participant is, in the opinion of the Investigator, unsuitable in any other way to participate in this study.
- If available, evidence of amyloid deposition on amyloid PET.
- Any new or change in prescription drugs prior to initial dosing, unless approved by the Investigator.
- Additional Exclusion Criteria for HVs
- The participant is currently exposed to nicotine products or had regular nicotine exposure within a six-month period, to be verified by urine cotinine screening
- Additional Exclusion Criteria for Participants With PSP
- Ongoing treatment with methylphenidate, modafinil, metoclopramide, alpha methyldopa, reserpine, or amphetamine derivative, for participants requiring DaTscan imaging.
- Participant has known hypersensitivity to iodine or potassium iodide (KI) in the opinion of the Investigator.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of [18F]APN-1607 as a PET Biomarker for Longitudinal Change in Tau Pathology in Participants With Progressive Supranuclear Palsy
The overall goal of this protocol is to evaluate [18F]APN-1607 as a PET radiotracer for measuring longitudinal change in tau pathology in participants with PSP.
Read the detailed description
The overall goal of this protocol is to evaluate [18F]APN-1607 as a PET radiotracer for measuring longitudinal change in tau pathology in participants with PSP. The specific objectives are:
- To characterize and demonstrate the longitudinal progression of tau deposition in vivo in participants with PSP.
- To determine optimal PET analysis parameters for [18F]APN-1607 quantification.
- To characterize the stability of tau deposition in vivo over time in healthy volunteers (HVs).
- To evaluate consistency of [18F]APN-1607 quantification in characterizing tau deposition.
- Conditions
- Progressive Supranuclear Palsy, Healthy Volunteers
- Being tested
- [18F] APN-1607
- Keywords
- PSP, HV
- Medical subject headings
- Supranuclear Palsy, Progressive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
[18F] APN-1607Drug
Subjects will undergo PET imaging using [18F]APN-1607.
| Study group | Role | What they receive |
|---|---|---|
| [18F]APN-1607 | Experimental | Participants will receive an IV bolus injection of [18F]APN-1607, followed by PET brain imaging. Receives: Drug: [18F] APN-1607 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in standardized uptake value ratios (SUVRs) of regional [18F]APN-1607.
The within-group change in standardized uptake value ratios (SUVRs) of regional [18F]APN-1607 binding within a priori defined cortical and subcortical brain regions from Baseline to Week 36 and Week 72.
Measured: 72 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2021
- Study start25 May 2021
- Primary completion9 Jan 2024
- Study completion9 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Progressive Supranuclear PalsyStudies 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 1
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Invicro
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- David Russell, M.D., Ph.D., Principal investigator, Invicro
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05005819
- Sponsor's protocol ID
- APN-1607 (9646)
- Status last verified
- Feb 2025
- First submitted
- 29 Jun 2021
- Last updated
- 20 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of [18F]APN-1607 as a PET Biomarker for Longitudinal Change in Tau Pathology in Participants With Progressive Supranuclear Palsy
- ClinicalTrials.gov ID
- NCT05005819
- Acronym / sponsor ID
- APN-1607 (9646)
- Conditions
- Progressive Supranuclear Palsy, Healthy Volunteers
- Keywords
- PSP, HV
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- InvicroUniversity, hospital or other
- Study start
- 25 May 2021 (actual)
- Primary completion
- 9 Jan 2024 (actual)
- Study completion
- 9 Jan 2024 (actual)
- First posted
- 16 Aug 2021 (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 protocol is to evaluate [18F]APN-1607 as a PET radiotracer for measuring longitudinal change in tau pathology in participants with PSP.
Detailed description
The overall goal of this protocol is to evaluate [18F]APN-1607 as a PET radiotracer for measuring longitudinal change in tau pathology in participants with PSP. The specific objectives are:
- To characterize and demonstrate the longitudinal progression of tau deposition in vivo in participants with PSP.
- To determine optimal PET analysis parameters for [18F]APN-1607 quantification.
- To characterize the stability of tau deposition in vivo over time in healthy volunteers (HVs).
- To evaluate consistency of [18F]APN-1607 quantification in characterizing tau deposition.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| [18F]APN-1607 | Experimental | Drug: [18F] APN-1607Participants will receive an IV bolus injection of [18F]APN-1607, followed by PET brain imaging. |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (22 listed)
- Males or females from 50 to 80 years of age at Screening, inclusive.
- Body weight range of ≥ 43 kg to ≤ 120 kg.
- Score ≥20 on the MMSE at Screening.
- For women of childbearing potential, agreement to remain abstinent (refrain from heterosexual intercourse) or use contraception, and agreement to refrain from donating eggs, as defined below:
- Male participants with partners of childbearing potential must commit to the use of 2 methods of contraception, one of which is a barrier method (ie, male condom with or without spermicidal jelly), for the study duration and 90 days after the last dose.
Key exclusion criteria (24 listed)
- Participants are only eligible if they do not fulfill any of the exclusion criteria for the participant group.
- Additional Exclusion Criteria for HVs
- The participant is currently exposed to nicotine products or had regular nicotine exposure within a six-month period, to be verified by urine cotinine screening
- Additional Exclusion Criteria for Participants With PSP
- Ongoing treatment with methylphenidate, modafinil, metoclopramide, alpha methyldopa, reserpine, or amphetamine derivative, for participants requiring DaTscan imaging.
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] APN-1607Subjects will undergo PET imaging using [18F]APN-1607. | Drug | [18F]APN-1607 |
Primary outcome
Change in standardized uptake value ratios (SUVRs) of regional [18F]APN-1607.
Time frame: 72 weeks
The within-group change in standardized uptake value ratios (SUVRs) of regional [18F]APN-1607 binding within a priori defined cortical and subcortical brain regions from Baseline to Week 36 and Week 72.
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 20 Feb 2025.
- Related InformationLink provided by the sponsor.
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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.
David Russell, M.D., Ph.D. principal investigator
Invicro
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing [18F] APN-1607 in people with Progressive Supranuclear Palsy and Healthy Volunteers, run by Invicro at 1 site in United States.
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 22 inclusion and 24 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 20 Feb 2025. 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 United States. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Change in standardized uptake value ratios (SUVRs) of regional [18F]APN-1607. (time frame: 72 weeks). 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 20 Feb 2025.