No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Healthy Volunteers Welcome
You do not need to have the condition being studied to take part.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
50 – 80
Sex
Any
Trial phase
Early Phase 1
Study type
Interventional
Purpose
Diagnostic
Participants needed
13 (estimated)
Sponsor
MODAG GmbH · Industry
Who this trial is looking for
This trial is looking for people with Parkinson's disease, Multiple system atrophy, or healthy controls. Participants will receive an injection of a drug for imaging and undergo brain scans to help researchers understand how the drug works.
Are You a Good Fit for This Trial?
You may be able to join if
I am aged 50 to 80 years old.
I have a diagnosis of Parkinson's disease or Multiple system atrophy.
I have been enrolled in the PPMI 002 Clinical study.
I have a brain MRI without significant neurological issues.
I have a positive or negative CSF α-synuclein seed amplification assay.
I have a Montreal Cognitive Assessment score of 24 or higher.
I do not have significant movement issues according to the MDS-UPDRS III.
You may not be able to join if
I have other neurodegenerative diseases like Alzheimer's.
I have taken certain medications within the past 6 months.
I am currently taking anticoagulants or antiplatelet medications.
I have conditions that make it unsafe for a lumbar puncture.
I have severe claustrophobia or metal implants that are MRI-incompatible.
I have known allergies to imaging agents like DaTscan or iodine.
I have participated in another clinical trial targeting α-synuclein in the past 6 months.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
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. Each participant will receive a single intravenous injection of \[¹⁸F\]MODAG-009, followed by PET imag…
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. Each participant will receive a single intravenous injection of \[¹⁸F\]MODAG-009, followed by PET imaging using the investigational United Imaging NeuroEXPLORER (NX) camera.
Trial Locations
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Status
Eligibility Criteria
Inclusion Criteria:
* Healthy Controls inclusion criteria:
1. Enrolled in the PPMI 002 Clinical study as a healthy control participant
2. Any gender aged 50 to 75 years of age
3. Negative CSF α-synuclein seed amplification assay (SAA)
4. Previously acquired (since inclusion in PPMI) brain …
Inclusion Criteria:
* Healthy Controls inclusion criteria:
1. Enrolled in the PPMI 002 Clinical study as a healthy control participant
2. Any gender aged 50 to 75 years of age
3. Negative CSF α-synuclein seed amplification assay (SAA)
4. Previously acquired (since inclusion in PPMI) brain MRI without evidence of significant neurological pathology.
5. 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.
6. 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 inclusion criteria:
1. Enrolled in the PPMI 002 Clinical study as a Parkinson's Disease (PD) or Prodromal participant
2. Any gender aged 50 to 80 years of age
3. Positive CSF SAA
4. 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 PD.
5. 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) inclusion criteria:
1. Any gender aged 50 to 75 years of age
2. 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)
3. Positive CSF SAA
4. 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.
5. Evidence of nigrostriatal degeneration on DaTscan obtained at screening or on previously acquired imaging since the onset of the motor symptoms attributed to MSA.
Exclusion Criteria:
* All Cohorts:
1. Clinical evidence of other neurodegenerative diseases, such as Alzheimer's disease
2. Any other medical or psychiatric condition or lab abnormality, which in the opinion of the investigator might preclude participation.
3. Received any of the following drugs: dopamine receptor blockers (neuroleptics), metoclopramide, lithium and reserpine, within 6 months of Baseline Visit.
4. 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.
5. Participation in an investigational drug trial targeting α-synuclein within the past 6 months prior to enrollment.
6. 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 applicable.
7. 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 thrombocytopenia.
8. 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 agents.
9. 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 discretion.
10. 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 at least 5 half-lives or specified duration per investigators judgement prior to imaging.
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