Parkinsons Disease (PD)Phase 1NCT07880379
MK-0947 PN-002: An Open-label Study to Evaluate Brain α-synuclein Deposition Using Positron Emission Tomography (PET) and [¹⁸F]MK-0947 in Participants With Parkinson's Disease (PD)
A Phase 1 study testing [¹⁸F]MK-0947 in people with Parkinsons Disease (PD) and Healthy Elderly Volunteers, run by XingImaging, LLC at 1 site in United States.
Trial summary
This is a single-center, open-label clinical study designed to evaluate alpha-synuclein (ASYN) deposition in the brain of participants with Parkinson's disease (PD), as compared with healthy elderly (HE) participants. Up to 18 participants (12 PD, 6 HE) are planned to be enrolled. Read more about this study
- Who is it for?
- Ages 40 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Parkinsons Disease (PD), Healthy Elderly Volunteers
- 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
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Aug 2026to 30 Sep 2027
- Phase
- Phase 1
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
- All Participants (PD, HE)
- Must voluntarily sign and date each informed consent, approved by the Research Ethics Committee (REC) prior to the initiation of screening or study-specific procedures.
- For women of childbearing potential, agreement to remain abstinent (refrain from heterosexual intercourse) or use contraception, and agreement to refrain from donating eggs for 90 days following the last PET scan in each study period, 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 (i.e., removal of ovaries, fallopian tubes, and/or uterus) or another cause as determined by the Investigator (e.g., 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 (i.e., male or female condom), for the study duration and 90 days after the last investigational agent injection.
- Male participants with partners of childbearing potential must commit to the use of 2 methods of contraception, one of which is a barrier method (i.e., male condom with or without spermicidal jelly), for the study duration and 90 days after the last investigational agent injection.
- Male participants must not donate sperm for the duration of the study and 90 days after the last investigational agent injection.
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- In the opinion of the Investigator, deemed to be physically able to participate in all visits throughout the duration of the trial.
- PD and HE Participants
- Adult males and/or females between the ages of 40 and 80 years old (inclusive) at the time of providing informed consent.
- The participant is in good health based on medical history and physical examination at screening.
- Score of ≥25 out of 30 on the MMSE, or score of ≥25 out of 30 on the MoCA.
- Participants with PD
- Diagnosed with clinically established Parkinson's disease according to UK-Brain bank clinical criteria. At least 2 cardinal motor features (including bradykinesia with resting tremor, rigidity, or postural instability) PD diagnosis established for at least 3 years, at the Screening Visit.
- Hoehn and Yahr score between 2-3.
- UPSIT score of ≤26
- Currently on stable PD medication in the judgment of the Investigator
- Participants are judged to be L-DOPA responsive and able to ambulate independently and without significant history of falls within 6 months.
Who cannot join
- All Participants (PD, HE)
- Unwilling or unable to provide written informed consent and/or follow the procedures outlined in the protocol, in the opinion of the investigator.
- A general medical condition that in the opinion of the investigator may impair participant safety or the scientific integrity of the study, including, but not limited to:
- Significant hepatic impairment
- Significant renal insufficiency
- Significant cardiovascular, pulmonary, endocrine, or systemic chronic inflammatory disorder
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- Clinically significant infection within 30 days at study entry
- History of severe allergic reactions or hypersensitivity to PET tracers or related compounds
- History of cancer that in the opinion of the investigator may impair participant safety or the scientific integrity of the study.
- Any disability that would, in the opinion of the investigator, prevent completion of study procedures or assessments (including but not limited to blindness or significant visual impairment, deafness or significant hearing impairment, speech impairment, or sensory or motor dysfunction).
- Participant is unable or unwilling to undergo CT, PET procedures or for whom MRI (Part 1 only) is contraindicated (e.g. have aneurysm clip, metal fragments, internal electrical devices such as a cochlear implant, spinal cord stimulator or pacemaker), have claustrophobia that cannot be medically managed or are unable to lie still for the imaging procedures.
- Prior participation in other radiologic 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.
- Pregnant or breastfeeding female.
- Refusal to use highly effective contraception if of childbearing potential (if applicable).
- Approximately 30 days prior enrollment in an experimental study evaluating pharmacological therapies.
- Current or prior participation in a trial of an investigational therapeutic product targeting alpha-synuclein, unless documented to have only received placebo.
- Any finding (including history and medication use) that would in the opinion of the Investigator compromise participant safety or the scientific integrity of the study.
- Unwillingness or inability to follow the procedures outlined in the protocol.
- Has received an investigational drug within 30 days or 5 plasma half-lives (whichever is longer) before inclusion into this study, unless in the opinion of the Investigator, such medication will not constitute a risk for participant safety or the scientific integrity of the study.
- Participant is mentally or legally incapacitated.
- Has any other clinically significant condition or situation that has the potential to interfere with study conduct, in the judgment of the investigator
- HE participants
- Current or active neurological brain disorder.
- First degree relative with idiopathic PD (parent, sibling, child).
- Major surgery or donation or loss of 400 mL or more of blood within 4 weeks prior to dosing, or longer if required by local regulation
- Participants with PD
- Have evidence of an alternative form of parkinsonism (e.g., drug-induced parkinsonism due to neuroleptic use) or other parkinsonian disorders (e.g., MSA, PSP), as determined by UK Brain Bank Clinical criteria or investigator judgement.
- Participant is a known mutation carrier of LRRK2, PINK1, PARK2, or DJ-1
- Have known history of negative SAA test (via skin punch or CSF sample) and/or DaTscan without evidence of striatal dopaminergic deficit.
- Have a modified Hoehn and Yahr score of 4 or greater
- Be living in a nursing home or assisted living facility
- Have a history of dementia (due to AD, PD, or other cause)
- Have a history of significant disabling CNS disease other than PD
- Have had a prior history of brain surgery
- Major surgery or donation or loss of 400 mL or more of blood within 4 weeks prior to dosing, or longer if required by local regulation
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
XingImaging, LLC
New Haven, Connecticut, 06510
Anna Carberry, 475-318-8250, clinicrecruitment@indd.org
Neha Prakash, MBBS
About this study
This is a single-center, open-label clinical study designed to evaluate alpha-synuclein (ASYN) deposition in the brain of participants with Parkinson's disease (PD), as compared with healthy elderly (HE) participants. Up to 18 participants (12 PD, 6 HE) are planned to be enrolled. Each participant will receive a single IV injection of [¹⁸F]MK-0947 as part of Part 1A followed by PET imaging using the Investigational United Imaging NeuroEXPLORER(NX) camera or the Siemens Biograph mCT camera. If enrolled in Part 1B a second injections and PET scan may be conducted in participants with PD and HE from Part 1A.
Read the detailed description
This is a single-center, open-label clinical study to evaluate the brain uptake and pharmacokinetics of [¹⁸F]MK-0947 in participants with PD, compare to HE participants, and demonstrate the utility of [18F]MK-0947 to quantify alpha synuclein pathology in participants with PD.
Part 1A will enroll participants with PD (up to 12) and HE (up to 6) to evaluate [¹⁸F]MK-0947 in the brain of participants with PD using two different PET scanners: either standard resolution (~5 mm) Siemens Biograph mCT PET scanner (Std PET), or an advanced high resolution (~1.5 mm) Investigational United Imaging NeuroEXPLORER® PET scanner (NX-PET).
Safety assessments will be collected during this time. The characteristics of [¹⁸F]MK-0947 in PD will be compared to those in HE participants.
Part 1B will acquire a second [¹⁸F]MK-0947 scan from some of the PD participants (up to 12) and HE participants (up to 6) from Part 1A on the scanner they were not scanned on in Part 1A.
- Being tested
- [¹⁸F]MK-0947
- Keywords
- MK-0947, MK-0947 PN-002, α-synuclein, alpha-synuclein, Neurodegeneration
- 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
Participants enrolled in the study will receive up to two single IV injections of [¹⁸F]MK-0947 followed by dynamic PET imaging using the United Imaging NeuroEXPLORER (NX) brain PET scanner, the Siemens Biograph mCT brain PET scanner, or both.
| Study group | Role | What they receive |
|---|---|---|
| Parkinson's disease (PD); Healthy Elderly (HE) | Experimental | Participants enrolled in the study will receive up to two single IV injections of [¹⁸F]MK-0947 followed by dynamic PET imaging using the United Imaging NeuroEXPLORER (NX) brain PET scanner, the Siemens Biograph mCT brain PET scanner, or both. Receives: Drug: [¹⁸F]MK-0947 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Brain uptake of [¹⁸F]MK-0947
To visually and quantitatively assess brain uptake of [¹⁸F]MK-0947 as a PET radioligand for alpha-synuclein pathology (e.g. Standard Uptake Value Ratios (SUVR)).
Measured: From imaging to follow up, an average of 1 year
Safety of [¹⁸F]MK-0947: Incidence of Adverse Events
Incidence of adverse events (AEs) following administration
Measured: From enrollment to follow up, an average of 1 year
Standard Uptake Value Ratios (SUVR)
To evaluate Standard Uptake Value Ratios (SUVR) in relevant brain regions from [18F]MK-0947 PET in PD and healthy participants.
Measured: From imaging to follow up, an average of 1 year
Secondary outcomes (2)
Binding Comparison of [¹⁸F]MK-0947 PD and Healthy Elderly
To compare the binding of [¹⁸F]MK-0947 in the brain of participants with PD with similarly age-matched HE via evaluation of suitable regional quantification parameter (e.g., SUVR) in regions known to be involved in α-synuclein pathology and regions known to not be involved in such pathology.
Measured: From imaging to follow up, an average of 1 year
Binding Comparison - Camera
To compare the binding of [¹⁸F]MK-0947 in the brain of participants with PD with that in HE using the standard- and NX- PET
Measured: From imaging to follow up, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2026
- Study start25 Aug 2026
- Primary completion30 Sep 2027 (estimated)
- Study completion30 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinsons 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
- Phase 1
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 18 participants (estimated)
Sponsor and investigators
- Lead sponsor
- XingImaging, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Neha Parkash, MBBS, Principal investigator, XingImaging, LLC and Institute for neurodegenerative Disorders
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07880379
- Sponsor's protocol ID
- MK-0947 PN-002
- Status last verified
- Sep 2026
- First submitted
- 24 Aug 2026
- Last updated
- 19 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided