Parkinson's Disease (PD)Early Phase 1NCT07348250
Open-label Study to Evaluate Brain α-Synuclein Deposition Using PET and [18F]MK-0947 in Parkinson's Disease
A Early Phase 1 study testing [18F]MK-0947 in people with Parkinson's Disease (PD) and Parkinson's Disease, run by Invicro at 1 site in United States.
Trial summary
This clinical study is being conducted to learn more about a new imaging drug called [18F]MK-0947, which is designed to help doctors see changes in the brain related to Parkinson's disease (PD). PD is a condition that affects movement, balance, and thinking. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Parkinson's Disease (PD), Parkinson's Disease, Parkinson's Disease (Disorder)
- What is being tested?
- [18F]MK-0947
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Dec 2025to 20 Jul 2026
- 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 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Signed informed consent prior to any study procedures
- Women of childbearing potential: abstinent or use 2 contraception methods (one barrier) during study and 90 days post last injection
- Men: use 2 contraception methods and refrain from sperm donation during study and 90 days post last injection
- PD \& HE participants: Age 40-80 years; HP participants: Age 18-50 years
- Adequate circulation and normal clotting for arterial cannulation (if applicable)
- HE participants: no neurological disorder, no first-degree relative with idiopathic PD
- HP participants: healthy with no clinically relevant findings
Who cannot join
- Unwilling or unable to provide informed consent
- Clinically significant hepatic, renal, cardiovascular, pulmonary, or systemic illness
- Pregnant or breastfeeding
- Contraindication to PET or MRI procedures (e.g., implants, claustrophobia)
- History of severe allergic reactions to PET tracers or related compounds
- Current or prior participation in investigational drug study within 30 days
- Any condition that may interfere with study conduct or participant safety
Trial locations and contacts
1 site in 1 country.
United States1 site
Invicro (dba Perceptive)
New Haven, Connecticut, 06510
About this study
Official title: An Open-label Study to Evaluate Brain α-Synuclein Deposition Using Positron Emission Tomography (PET) and [18F]MK-0947 in Patients With Parkinson's Disease
This clinical study is being conducted to learn more about a new imaging drug called [18F]MK-0947, which is designed to help doctors see changes in the brain related to Parkinson's disease (PD). PD is a condition that affects movement, balance, and thinking. The drug works with a type of scan called PET (Positron Emission Tomography) to show areas of the brain where a protein called α-synuclein builds up. This buildup is linked to PD and other brain disorders.
The main goal of this study is to find out if [18F]MK-0947 is safe for people and if it works well to show α-synuclein in the brain. The study will also look at how the drug moves through the body and how much radiation it gives off. Researchers hope this information will help develop better tools for diagnosing PD and tracking how it changes over time.
Read more
Who can join? Adults who have PD or who are healthy may be able to take part. Participants will have screening tests to make sure they qualify.
What does participation involve? People in the study will have PET scans, blood tests, and other safety checks. Some participants will also have an MRI scan. The study is divided into two parts: Part 1 looks at how the drug works in the brain of PD patients and healthy elderly participants, and Part 2 measures radiation levels in healthy participants.
Why is this important? There is currently no cure for PD, and better imaging tools could help researchers develop new treatments. By joining this study, participants will help advance research that may improve care for people with PD and similar conditions in the future.
Read the detailed description
This Phase 1, open-label study will evaluate the safety, pharmacokinetics, and imaging characteristics of [18F]MK-0947, a novel PET tracer targeting α-synuclein pathology in Parkinson's disease (PD). The study consists of two parts: Part 1 includes PD and healthy elderly participants for brain imaging using standard and high-resolution PET scanners; Part 2 includes healthy participants for whole-body dosimetry to estimate radiation exposure. Imaging sessions will involve dynamic PET scans lasting up to 2 hours, arterial or venous blood sampling for kinetic modeling, and MRI for anatomical co-registration. Safety assessments include vital signs, ECGs, laboratory tests, and adverse event monitoring. The investigational tracer will be administered intravenously at doses up to 10 mCi, with strict adherence to radiation safety guidelines. Data will be analyzed using compartmental and graphical modeling approaches to derive quantitative metrics such as SUV, SUVR, VT, and DVR. This study aims to establish proof of concept for [18F]MK-0947 as a biomarker for α-synuclein pathology, supporting future therapeutic trials and advancing diagnostic capabilities for synucleinopathies.
- Being tested
- [18F]MK-0947
- Keywords
- alpha-synuclein, α-synuclein, Neurodegeneration, MK-0947
- Medical subject headings
- Parkinson Disease, Parkinson Disease 4, Autosomal Dominant Lewy Body, Nerve Degeneration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
[18F]MK-0947Drug
Also called MK-0947
PET radiopharmaceutical selective for α-synuclein, administered IV at doses up to 10 mCi.
| Study group | Role | What they receive |
|---|---|---|
| Part 1 - Brain Imaging | Experimental | Participants receive [18F]MK-0947 for PET imaging of the brain. Receives: Drug: [18F]MK-0947 |
| Part 2 - Dosimetry | Experimental | Healthy participants receive [18F]MK-0947 for whole-body dosimetry. Receives: Drug: [18F]MK-0947 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety of [18F]MK-0947: Incidence of Adverse Events
Incidence of adverse events (AEs) following administration
Measured: Up to 4 months
Safety of [18F]MK-0947: Radiation absorbed dose estimates
Radiation absorbed dose estimates following administration derived from PET imaging and dosimetry calculations.
Measured: 4 months
Secondary outcomes (2)
Brain uptake of [18F]MK-0947
Quantitative assessment of [18F]MK-0947 uptake in brain regions measured by PET imaging.
Measured: Up to 36 days
Model-derived Pharmacokinetics of [18F]MK-0947
Pharmacokinetic parameters of [18F]MK-0947 derived from dynamic PET imaging and plasma input functions.
Measured: Up to 36 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2026
- Study start8 Dec 2025
- Primary completion26 Mar 2026
- Study completion20 Jul 2026
Why it stopped: Study terminated due to site closure.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson's Disease (PD)Studies 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
- Early Phase 1
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Invicro
- Sponsor type
- University, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07348250
- Sponsor's protocol ID
- MK-0947 PN001
- Status last verified
- Jul 2026
- First submitted
- 29 Dec 2025
- Last updated
- 27 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label Study to Evaluate Brain α-Synuclein Deposition Using Positron Emission Tomography (PET) and [18F]MK-0947 in Patients With Parkinson's Disease
- ClinicalTrials.gov ID
- NCT07348250
- Acronym / sponsor ID
- MK-0947 PN001
- Keywords
- alpha-synuclein, α-synuclein, Neurodegeneration, MK-0947
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study terminated due to site closure.
- Enrolment
- 16 participants (actual)
- Lead sponsor
- InvicroUniversity, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Study start
- 8 Dec 2025 (actual)
- Primary completion
- 26 Mar 2026 (actual)
- Study completion
- 20 Jul 2026 (actual)
- First posted
- 16 Jan 2026 (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.
This clinical study is being conducted to learn more about a new imaging drug called [18F]MK-0947, which is designed to help doctors see changes in the brain related to Parkinson's disease (PD). PD is a condition that affects movement, balance, and thinking. The drug works with a type of scan called PET (Positron Emission Tomography) to show areas of the brain where a protein called α-synuclein builds up. This buildup is linked to PD and other brain disorders.
The main goal of this study is to find out if [18F]MK-0947 is safe for people and if it works well to show α-synuclein in the brain. The study will also look at how the drug moves through the body and how much radiation it gives off. Researchers hope this information will help develop better tools for diagnosing PD and tracking how it changes over time.
Who can join? Adults who have PD or who are healthy may be able to take part. Participants will have screening tests to make sure they qualify.
What does participation involve? People in the study will have PET scans, blood tests, and other safety checks. Some participants will also have an MRI scan. The study is divided into two parts: Part 1 looks at how the drug works in the brain of PD patients and healthy elderly participants, and Part 2 measures radiation levels in healthy participants.
Why is this important? There is currently no cure for PD, and better imaging tools could help researchers develop new treatments. By joining this study, participants will help advance research that may improve care for people with PD and similar conditions in the future.
Detailed description
This Phase 1, open-label study will evaluate the safety, pharmacokinetics, and imaging characteristics of [18F]MK-0947, a novel PET tracer targeting α-synuclein pathology in Parkinson's disease (PD). The study consists of two parts: Part 1 includes PD and healthy elderly participants for brain imaging using standard and high-resolution PET scanners; Part 2 includes healthy participants for whole-body dosimetry to estimate radiation exposure. Imaging sessions will involve dynamic PET scans lasting up to 2 hours, arterial or venous blood sampling for kinetic modeling, and MRI for anatomical co-registration. Safety assessments include vital signs, ECGs, laboratory tests, and adverse event monitoring. The investigational tracer will be administered intravenously at doses up to 10 mCi, with strict adherence to radiation safety guidelines. Data will be analyzed using compartmental and graphical modeling approaches to derive quantitative metrics such as SUV, SUVR, VT, and DVR. This study aims to establish proof of concept for [18F]MK-0947 as a biomarker for α-synuclein pathology, supporting future therapeutic trials and advancing diagnostic capabilities for synucleinopathies.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Part 1 - Brain Imaging | Experimental | Drug: [18F]MK-0947Participants receive [18F]MK-0947 for PET imaging of the brain. |
| Part 2 - Dosimetry | Experimental | Drug: [18F]MK-0947Healthy participants receive [18F]MK-0947 for whole-body dosimetry. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Signed informed consent prior to any study procedures
- Women of childbearing potential: abstinent or use 2 contraception methods (one barrier) during study and 90 days post last injection
- Men: use 2 contraception methods and refrain from sperm donation during study and 90 days post last injection
- PD \& HE participants: Age 40-80 years; HP participants: Age 18-50 years
- Adequate circulation and normal clotting for arterial cannulation (if applicable)
Key exclusion criteria (7 listed)
- Unwilling or unable to provide informed consent
- Clinically significant hepatic, renal, cardiovascular, pulmonary, or systemic illness
- Pregnant or breastfeeding
- Contraindication to PET or MRI procedures (e.g., implants, claustrophobia)
- History of severe allergic reactions to PET tracers or related compounds
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]MK-0947Also: MK-0947PET radiopharmaceutical selective for α-synuclein, administered IV at doses up to 10 mCi. | Drug | Part 1 - Brain Imaging, Part 2 - Dosimetry |
Primary outcome
Safety of [18F]MK-0947: Incidence of Adverse Events
Time frame: Up to 4 months
Incidence of adverse events (AEs) following administration
Safety of [18F]MK-0947: Radiation absorbed dose estimates
Time frame: 4 months
Radiation absorbed dose estimates following administration derived from PET imaging and dosimetry calculations.
2 secondary outcomes
Brain uptake of [18F]MK-0947
Time frame: Up to 36 days
Model-derived Pharmacokinetics of [18F]MK-0947
Time frame: Up to 36 days
Results and safety
The study was stopped early (reason given: Study terminated due to site closure.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2026.
- 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.
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]MK-0947 in people with Parkinson's Disease (PD) and Parkinson's Disease, 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 7 inclusion and 7 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: stopped early, as of the sponsor's last update on 27 Jul 2026. 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?
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 was stopped early (reason given: Study terminated due to site closure.). Results are not available in the source record.
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?
Safety of [18F]MK-0947: Incidence of Adverse Events (time frame: Up to 4 months). 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 27 Jul 2026.