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New treatment option for Multiple System Atrophy (MSA)
Official title Evaluation of [¹⁸F]MODAG-009 PET Imaging in Synucleinopathies
ClinicalTrials.gov ID: NCT07640555
What this study is testing
What is [¹⁸F]MODAG-009 PET imaging?
[¹⁸F]MODAG-009 PET imaging is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for multiple system atrophy (msa).
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This is a single-center, open-label clinical study designed to evaluate the imaging characteristics and safety of [¹⁸F]MODAG-009 in participants with Parkinson's disease (PD), Multiple system atrophy (MSA), and Healthy controls (HC). Approximately 13 participants will be enrolled in this study.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 50 to 80. Healthy volunteers may be eligible.
You may be able to join if
- Healthy Controls
- Enrolled in the PPMI 002 Clinical study as a healthy control participant
- Any gender aged 50 to 75 years of age
- Negative CSF α-synuclein seed amplification assay (SAA)
- Previously acquired (since inclusion in PPMI) brain MRI without evidence of significant neurological pathology.
You likely can't join if
- All Cohorts:
- Clinical evidence of other neurodegenerative diseases, such as Alzheimer's disease
- Any other medical or psychiatric condition or lab abnormality, which in the opinion of the investigator might preclude participation.
- Received any of the following drugs: dopamine receptor blockers (neuroleptics), metoclopramide, lithium and reserpine, within 6 months of Baseline...
- Any other reason that in the opinion of the investigator, including abnormal labs, that could interfere with the safety with radiotracer injection...
- Participation in an investigational drug trial targeting α-synuclein within the past 6 months prior to enrollment.
See the full eligibility criteria
- Healthy Controls
- Enrolled in the PPMI 002 Clinical study as a healthy control participant
- Any gender aged 50 to 75 years of age
- Negative CSF α-synuclein seed amplification assay (SAA)
- Previously acquired (since inclusion in PPMI) brain MRI without evidence of significant neurological pathology.
- Movement Disorders Society- Unified Parkinson's Disease Rating Scale Part III (MDS-UPDRS III) score of \<6 at the last PPMI annual visit which is within the past 18 months.
- Cognitively intact with Montreal Cognitive Assessment (MoCA) greater than or equal to 26 at the last PPMI annual visit which was within the past 18 months.
- Parkinson's Disease and Prodromal PD
- Enrolled in the PPMI 002 Clinical study as a Parkinson's Disease (PD) or Prodromal participant
- Any gender aged 50 to 80 years of age
- Positive CSF SAA
- A current or previously acquired brain MRI (since the onset of motor symptoms for PD or since enrolled in PPMI for the prodromal PD) without evidence of significant neurological pathology other than changes expected for...
- Montreal Cognitive Assessment (MoCA) greater than or equal to 24 at the last PPMI annual visit which was within the past 18 months.
- Multiple System Atrophy (MSA)
- Any gender aged 50 to 75 years of age
- Clinically established MSA or Clinically Probable MSA according to the Movement Disorder Society Criteria for the Diagnosis of Multiple System Atrophy (Wenning et al., 2022)
- Positive CSF SAA
- A current or previously acquired brain MRI (since the onset of motor symptoms attributed to MSA) without evidence of significant neurological pathology other than the pathology expected for MSA.
- Evidence of nigrostriatal degeneration on DaTscan obtained at screening or on previously acquired imaging since the onset of the motor symptoms attributed to MSA.
- All Cohorts:
- Clinical evidence of other neurodegenerative diseases, such as Alzheimer's disease
- Any other medical or psychiatric condition or lab abnormality, which in the opinion of the investigator might preclude participation.
- Received any of the following drugs: dopamine receptor blockers (neuroleptics), metoclopramide, lithium and reserpine, within 6 months of Baseline Visit.
- Any other reason that in the opinion of the investigator, including abnormal labs, that could interfere with the safety with radiotracer injection, would render the participant unsuitable for the study enrollment.
- Participation in an investigational drug trial targeting α-synuclein within the past 6 months prior to enrollment.
- Currently being treated with and unable to safely hold antiplatelets (other than low dose aspirin up to 100mg/day) or anticoagulants prior to the procedure that might preclude safe attempt of Lumbar puncture, if...
- Condition that precludes the safe performance of routine lumbar puncture, if applicable, such as prohibitive lumbar spinal disease, bleeding diathesis, or clinically significant and uncorrected coagulopathy or...
- Conditions or medications that preclude safe performance of imaging procedures (MRI or DaTscan), including but not limited to severe claustrophobia, MRI-incompatible metal implants, or known hypersensitivity to imaging...
- Known hypersensitivity to DaTscan or iodine-containing compounds used as premedication for DaTscan. Participants with iodine sensitivity may still complete the imaging without iodine premedication at the investigator's...
- Use of medications known to interfere with DaTscan imaging (e.g., bupropion, amphetamines, methylphenidate, modafinil, alpha-methyldopa), unless the participant is willing and medically able to hold the medication for...
The study team makes the final eligibility decision.
Where it's taking place
- New Haven, Connecticut, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 50 years to 80 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include New Haven, Connecticut, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.