[18F]MK-0947 for Parkinson's Disease

Overseen By David Russell, MD, PhD

Age: 18+

Sex: Any

Trial Phase: Phase < 1

Sponsor: Invicro

Disqualifiers: Hepatic, Renal, Cardiovascular, Pulmonary, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

22 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new imaging drug called [18F]MK-0947, designed to help doctors detect brain changes linked to Parkinson’s disease (PD), a condition affecting movement and thinking. The drug works with a PET scan to highlight the buildup of a protein associated with PD. The trial aims to determine if the drug is safe and effective in revealing these changes. Adults with PD or healthy individuals may be eligible to join, especially if they can undergo PET scans and other safety tests. Participants will contribute to research that could lead to improved diagnosis and treatment options for PD. As an Early Phase 1 trial, this study focuses on understanding how this new drug works in people, offering participants the chance to be among the first to receive this innovative treatment.

What prior data suggests that [18F]MK-0947 is safe for use in brain imaging?

Research has shown that [18F]MK-0947 is under careful study to ensure its safety for people. Although specific safety data is not yet available, it is important to note that this study is in an early stage. Researchers are focusing on how the drug functions in the body and monitoring for any side effects.

[18F]MK-0947 is used in PET scans to help doctors observe changes in the brain related to Parkinson's disease. It is not a regular treatment like a pill. Instead, it helps doctors identify where certain proteins accumulate in the brain, aiding in a better understanding of the disease.

No specific side effects have been reported for [18F]MK-0947 so far, but since testing is in its early stages, scientists are closely monitoring how people tolerate it and any possible reactions. Participants will undergo safety checks, such as blood tests, to assess their body's response to the drug.

Joining the study contributes to important research that could lead to improved methods for diagnosing and tracking Parkinson's disease. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about [18F]MK-0947 because it offers a new way to study Parkinson's disease through advanced brain imaging. While standard treatments for Parkinson's, like levodopa or dopamine agonists, focus on symptom relief, [18F]MK-0947 is used in PET scans to visualize brain activity more precisely. This could lead to better understanding of the disease's progression and more targeted treatments in the future. Additionally, the dosimetry arm in healthy participants helps ensure its safety and effectiveness in mapping out the whole body's interaction with the drug.

What evidence suggests that this imaging drug is effective for showing α-synuclein in the brain related to Parkinson's disease?

Research has shown that the imaging drug [18F]MK-0947 is being studied as a new method to detect a protein called α-synuclein in the brain. This protein accumulates in people with Parkinson's disease and is linked to disease progression. In this trial, participants will receive [18F]MK-0947 for PET imaging of the brain or for whole-body dosimetry. The researchers aim for [18F]MK-0947, when used with PET scans, to make this buildup visible, potentially leading to better diagnosis and monitoring of Parkinson's. Although limited data currently exist on [18F]MK-0947's effectiveness in humans, the approach is promising because it targets a key protein involved in Parkinson's. This could eventually aid in developing more effective treatments for people with the disease. ^{1 4 6 7 8}

Are You a Good Fit for This Trial?

This study is for adults aged 40-80 with Parkinson's Disease (PD) and healthy individuals aged 18-50. Participants must consent, use two forms of contraception if applicable, and have good blood circulation. Healthy participants should not have neurological disorders or a family history of PD.

Inclusion Criteria

HP participants: healthy with no clinically relevant findings

I will use two methods of contraception and not donate sperm during the study and for 90 days after.

I am between 40-80 years old with PD or HE, or 18-50 years old with HP.

Exclusion Criteria

Unwilling or unable to provide informed consent

I do not have any major liver, kidney, heart, lung, or systemic diseases.

Pregnant or breastfeeding

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Part 1 - Brain Imaging

Participants receive [18F]MK-0947 for PET imaging of the brain to evaluate α-synuclein deposition

Up to 36 days

Multiple visits for PET scans and safety assessments

Part 2 - Dosimetry

Healthy participants receive [18F]MK-0947 for whole-body dosimetry to estimate radiation exposure

Up to 36 days

Multiple visits for dosimetry and safety assessments

Follow-up

Participants are monitored for safety and effectiveness after administration of [18F]MK-0947

4 months

What Are the Treatments Tested in This Trial?

Interventions

• [18F]MK-0947

Trial Overview

[18F]MK-0947, an imaging drug used in PET scans to detect α-synuclein protein buildup in the brain associated with PD, is being tested for safety and effectiveness. The study includes PET scans, blood tests, possibly MRI scans, and tracks how the drug moves through the body.

How Is the Trial Designed?

Group I: Part 2 - Dosimetry Experimental Treatment 1 Intervention

Healthy participants receive \[18F\]MK-0947 for whole-body dosimetry.

Group II: Part 1 - Brain Imaging Experimental Treatment 1 Intervention

Participants receive \[18F\]MK-0947 for PET imaging of the brain.

Who Is Running the Clinical Trial?

Invicro

Lead Sponsor

Trials

19

Recruited

380+

Merck Sharp & Dohme LLC

Industry Sponsor

Trials

4,096

Recruited

5,232,000+

Chirfi Guindo

Merck Sharp & Dohme LLC

Chief Marketing Officer since 2022

Degree in Engineering from Ecole Centrale de Paris, MBA from New York University Stern School of Business

Robert M. Davis

Merck Sharp & Dohme LLC

Chief Executive Officer since 2021

JD from Northwestern University Pritzker School of Law, MBA from Northwestern University Kellogg Graduate School of Management, Bachelor's in Finance from Miami University

Citations

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clinicaltrials.gov/study/NCT07348250?term=physio+OR+physical+therapy+OR+exercise+therapy+OR+physiotherapy

Open-label Study to Evaluate Brain α-Synuclein Deposition ...

This study aims to establish proof of concept for [18F]MK-0947 as a biomarker for α-synuclein pathology, supporting future therapeutic trials ...

2.

alzforum.org

alzforum.org/print-series/3423841

AD/PD™ 2025: Advances in Science & Therapy

A trial of MK-0947 will start later this year, with readout expected in 2026. ... The spatial extent of tauopathy on [18F]MK-6240 tau PET ...

3.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC12391019/

The Next Frontier in Parkinson's Disease Treatment

Adaptive DBS adjusts stimulation in response to real‐time brain signals, showing improved motor outcomes and the overall energy efficiency [44].

4.

frontiersin.org

frontiersin.org/journals/pharmacology/articles/10.3389/fphar.2020.00953/pdf

An [18F]FE-PE2I Positron Emission Tomog

Fas-associated factor 1 (FAF1), a Fas-binding protein, is implicated in neuronal cell death in ParkinsonLs disease (PD). We examined the effects ...

5.

pubs.acs.org

pubs.acs.org/doi/10.1021/acs.jmedchem.3c00775

In Silico Discovery and Subsequent Characterization of Potent ...

Our results suggest that the 18F-MK-6240 ... Our data indicate that MK-6240 strongly binds to neurofibrillary tangles in Alzheimer disease ...

6.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/40753721/

Discovery and validation of biomarkers for Parkinson's ...

Discovery and validation of biomarkers for Parkinson's disease from human cerebrospinal fluid using mass spectrometry-based proteomics analysis.

7.

clinicaltrials.gov

clinicaltrials.gov/study/NCT01462708

NCT01462708 | Evaluation of [18F]MK-9470 as a Brain ...

The underlying goal of this study is to assess MK-9470 PET imaging as a tool to evaluate the activity of the CB-1 receptor in the brain of ...

8.

michaeljfox.org

michaeljfox.org/grant/assessment-brain-tau-burden-parkinsons-disease-or-without-lrrk2-mutation-using-18fmk-6240-pet

Assessment of Brain Tau Burden in Parkinson's Disease ...

If [18F]MK-6240 PET imaging does reveal tau deposits in some people with Parkinson's, then this imaging tool could be used to identify them and follow their ...