[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"MODAG GmbH\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":102},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,49,76],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":14,"eligibilityCriteria":15,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":31,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":38,"lastUpdatePostDateStruct":39,"startDateStruct":42,"completionDateStruct":44,"leadSponsor":46,"locationsCount":48},"100642604","early-phase-1-evaluation-of-fmodag-009-pet-imaging-in-synucleinopathies-100642604",false,"NCT07640555","Evaluation of [¹⁸F]MODAG-009 PET Imaging in Synucleinopathies","MODAG-009-P1-0","Inclusion Criteria:\n\n* Healthy Controls inclusion criteria:\n\n  1. Enrolled in the PPMI 002 Clinical study as a healthy control participant\n  2. Any gender aged 50 to 75 years of age\n  3. Negative CSF α-synuclein seed amplification assay (SAA)\n  4. Previously acquired (since inclusion in PPMI) brain MRI without evidence of significant neurological pathology.\n  5. Movement Disorders Society- Unified Parkinson's Disease Rating Scale Part III (MDS-UPDRS III) score of \\\u003C6 at the last PPMI annual visit which is within the past 18 months.\n  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.\n* Parkinson's Disease and Prodromal PD inclusion criteria:\n\n  1. Enrolled in the PPMI 002 Clinical study as a Parkinson's Disease (PD) or Prodromal participant\n  2. Any gender aged 50 to 80 years of age\n  3. Positive CSF SAA\n  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.\n  5. Montreal Cognitive Assessment (MoCA) greater than or equal to 24 at the last PPMI annual visit which was within the past 18 months.\n* Multiple System Atrophy (MSA) inclusion criteria:\n\n  1. Any gender aged 50 to 75 years of age\n  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)\n  3. Positive CSF SAA\n  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.\n  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.\n\nExclusion Criteria:\n\n* All Cohorts:\n\n  1. Clinical evidence of other neurodegenerative diseases, such as Alzheimer's disease\n  2. Any other medical or psychiatric condition or lab abnormality, which in the opinion of the investigator might preclude participation.\n  3. Received any of the following drugs: dopamine receptor blockers (neuroleptics), metoclopramide, lithium and reserpine, within 6 months of Baseline Visit.\n  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.\n  5. Participation in an investigational drug trial targeting α-synuclein within the past 6 months prior to enrollment.\n  6. Currently being treated with and unable to safely hold antiplatelets (other than low dose aspirin up to 100mg\u002Fday) or anticoagulants prior to the procedure that might preclude safe attempt of Lumbar puncture, if applicable.\n  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.\n  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.\n  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.\n  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.",true,"ALL","50 Years","80 Years",{"count":21,"type":22},13,"ESTIMATED","INTERVENTIONAL",[25],"EARLY_PHASE1","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.",[28,29,30],"Multiple System Atrophy (MSA)","Healthy Adult","Parkinson Disease",[32,33,34,35,36],"MODAG","MODAG GmbH","MODAG-009","PET Tracer","Synuclein","RECRUITING","2026-06-06",{"date":40,"type":41},"2026-06-10","ACTUAL",{"date":43,"type":41},"2026-05-13",{"date":45,"type":22},"2027-05",{"name":33,"class":47},"INDUSTRY",1,{"id":50,"slug":51,"hasResults":11,"nctId":52,"briefTitle":53,"officialTitle":54,"acronym":55,"eligibilityCriteria":56,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":57,"enrollmentInfo":58,"targetDuration":4,"studyType":23,"phases":60,"briefSummary":61,"conditions":62,"keywords":66,"overallStatus":69,"whyStopped":4,"lastUpdateSubmitDate":38,"lastUpdatePostDateStruct":70,"startDateStruct":71,"completionDateStruct":73,"leadSponsor":75,"locationsCount":4},"100643640","early-phase-1-test-retest-trial-with-11cmodag-005-in-pd-or-msa-and-amhc---pilot-phase-100643640","NCT07640542","Test-retest Trial With [11C]MODAG-005 in PD or MSA and AMHC - Pilot Phase","An Open-label, Single-center Study to Evaluate the Safety and Test-retest Characteristics of [11C]MODAG-005 as PET Radioligand for Imaging Pathological Alpha-synuclein Deposition in the Brains of Patients With Parkinson's Disease (PD) or Multiple System Atrophy (MSA) Compared to Age-matched Healthy Controls (AMHC) - Pilot Phase","PIOSA","Inclusion Criteria:\n\n* Key inclusion criteria: Patients with MSA fulfilling both the criteria for probable MSA (Gilman et al., 2008) and clinically established MSA (Wenning et al., 2022), patients with PD fulfilling the criteria for clinically established PD (Postuma et al., 2015) or age-matched healthy controls (AMHC).\n\nExclusion Criteria:\n\n1. Laboratory tests with clinically significant abnormalities and\u002For clinically significant unstable medical illness equivalent to CTC v5.0 (common toxicity criteria) toxicities greater than grade 2.\n2. Evidence of clinically significant disease that is expected to interfere with cognitive assessments or the ability to complete the trial procedures as judged by the investigator.\n3. Clinically significant renal and hepatic dysfunction as judged by the investigator.\n4. Known hypersensitivity to the active substance or to any of the excipients of \\[11C\\]MODAG-005 solution for injection.\n5. Known hypersensitivity to the active substance or to any of the excipients in anle138b (Emrusolmin) capsules.\n6. Participant has received an investigational drug within 3 months of screening.\n7. Blood donations within 7 days before enrolment.\n8. Pregnant (see 9.1.5) or breast-feeding or having the intention of getting pregnant. Female participants of childbearing potential and male participants with female partners of childbearing potential not willing to practice effective contraception during the trial period and for 90 days following each PET\u002FCT scan.\n9. Unsuitable veins for repeated venipuncture.\n10. Contraindication to blood sampling and\u002For arterial cannulation, including but not limited to allergy to local anesthetics, peripheral vascular disease, Raynaud's phenomenon as determined by abnormal Allen's test on both arms or abnormal coagulation profile at screening. If Allen's test should be \"abnormal\" on both arms, the participant will not be eligible for arterial sampling, but will participate in the remaining assessments.\n11. MRI exclusion criteria include but not limited to: findings of cerebrovascular disease (more than two lacunar infarcts, any territorial infarct \\>1 cm\\^3, or deep white matter abnormality corresponding to an overall Fazekas scale of 3 with at least one confluent hyperintense lesion on the Fluid-Attenuated Inversion Recov ery (FLAIR) sequence that is \\>20 mm in any dimension), infectious disease, space-occupying lesions normal pressure hydrocephalus or any other abnormalities associated with central nervous system (CNS) disease. Findings that are expected to be present in the PD and MSA participants (e.g. absence of swallow tail sign, presence of regional atrophy or hot cross bun sign) do not lead to exclusion of these participants.\n12. Implants such as implanted cardiac pacemakers or defibrillators, insulin pumps, cochlear implants, metallic ocular foreign body, implanted neural stimulators, CNS aneurysm clips and other medical implants that have not been certified for MRI, or history of claustrophobia in MRI.\n13. Unwilling and\u002For unable to cooperate with trial procedures.\n\n    Exclusion criteria for age-matched healthy controls:\n14. Relevant hepatic parameters above upper limit of normal (ULN), i.e., glutamic pyruvic transaminase (GPT), glutamic oxaloacetic transaminase (GOT), bilirubin\n15. Relevant renal parameters outside normal limits, i.e., serum creatinine and blood urea nitrogen (BUN) above ULN; urinary albumin-creatinine ratio (uACR) below lower limit of normal (LLN)\n16. Systolic blood pressure \\\u003C90 or \\>140 mmHg; diastolic blood pressure \\\u003C45 or \\>90 mmHg; heart rate \\\u003C50 or \\>95 beats per minute (BPM)","75 Years",{"count":59,"type":22},9,[25],"This is an open-label, single-center Phase 1 study evaluating the safety, tolerability, and test-retest characteristics of \\[11C\\]MODAG-005, an investigational positron emission tomography\u002Fcomputed tomography (PET\u002FCT) radioligand intended to image pathological alpha-synuclein deposition in the brain. The study will enroll participants with Parkinson's disease (PD), participants with multiple system atrophy (MSA), and age-matched healthy controls (AMHC).\n\nParticipants with PD or MSA will undergo two \\[11C\\]MODAG-005 PET\u002FCT imaging sessions: one baseline scan and one follow-up scan 7 to 48 days later. Age-matched healthy controls will undergo one baseline scan. A subset of PD and MSA participants will receive a single oral dose of anle138b (Emrusolmin) before the second scan to evaluate tracer uptake under blocking conditions. The primary objective is to assess the safety and tolerability of \\[11C\\]MODAG-005. Secondary objectives include evaluating whether \\[11C\\]MODAG-005 PET imaging can distinguish participants with MSA or PD from age-matched healthy controls, distinguish PD from MSA, and determine test-retest variability of PET outcome measures.",[63,64,65],"Parkinson Disease (PD)","MSA - Multiple System Atrophy","Healthy Adult Participants",[32,33,36,67,68],"Neurodegeneration","Lewy Body","NOT_YET_RECRUITING",{"date":40,"type":41},{"date":72,"type":22},"2026-06",{"date":74,"type":22},"2027-07",{"name":33,"class":47},{"id":77,"slug":78,"hasResults":11,"nctId":79,"briefTitle":80,"officialTitle":80,"acronym":4,"eligibilityCriteria":81,"healthyVolunteers":16,"sex":17,"minAge":82,"maxAge":83,"enrollmentInfo":84,"targetDuration":4,"studyType":23,"phases":86,"briefSummary":87,"conditions":88,"keywords":89,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":95,"lastUpdatePostDateStruct":96,"startDateStruct":98,"completionDateStruct":100,"leadSponsor":101,"locationsCount":48},"100640482","early-phase-1-evaluation-of-the-pharmacokinetics-biodistribution-and-radiation-dosimetry-of-18fmodag-009-positron-emission-tomography-pet-radiotracers-in-adult-healthy-volunteers-100640482","NCT07617688","Evaluation of the Pharmacokinetics, Biodistribution and Radiation Dosimetry of [18F]MODAG-009 Positron Emission Tomography (PET) Radiotracers in Adult Healthy Volunteers","Inclusion Criteria:\n\n* Male or Female,\n* aged 18 to 60 years old\n* in good health as determined by past medical history, physical examination, vital signs, electrocardiogram, and laboratory tests at screening.\n* Ability to comply with the study procedures.\n* Able to understand and sign written informed consent from the participant.\n* Male and Females must meet additional criteria specified below, as applicable\n* a. Females must be of non-childbearing potential or using a highly effective method of birth control 14 days prior to until at least 24 hours after injection of \\[18F\\]MODAG-009. (i. Non-childbearing potential is defined as a female that must be either postmenopausal (no menses for at least 12 months prior to PET scan) or surgically sterile (bilateral tubal ligation, bilateral oophorectomy or hysterectomy). ii. Highly effective method of birth control is defined as practicing at least one of the following: A birth control method that results in a less than 1% per year failure rate when used consistently and correctly, such as oral contraceptives for at least 3 months prior to injection, an intrauterine device (IUD) for at least 2 months prior to injection, or barrier methods, e.g., diaphragm or combination condom and spermicide. Periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods) is not acceptable.)\n* b. Females of childbearing potential must not be pregnant, breastfeeding or lactating, or planning pregnancy during the duration of the study.\n* c. Males with female partners of childbearing potential must use adequate contraceptive methods and refrain from sperm donation for 90 days after injection of \\[18F\\]MODAG-009\n\nExclusion Criteria:\n\n* Use of any prescription drugs, herbal supplements, within four (4) weeks prior to initial dosing, and\u002For over-the-counter (OTC) medication, dietary supplements (vitamins included) within two (2) weeks prior to initial dosing. If needed (i.e. an incidental and limited need), acetaminophen is acceptable, but must be documented as a concomitant medication \u002F significant non-drug therapy. Participation in any clinical interventional studies within four (4) weeks prior to initial dosing or 5 half-lives of the investigational agent if known and longer than four (4) weeks.\n* Participants with a history of exposure to any radiation \\>50 mSv\u002Fyear (e.g., occupational or radiation therapy) over the past year. Donation or loss of 400 ml or more of blood within eight (8) weeks prior to initial dosing, or longer if required by local regulation.\n* Have a history or presence of any significant cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, or neurological disorders which, in the opinion of the investigator, are capable of altering the absorption, metabolism, or elimination of drugs or posing a health risk to participate in the study.\n* Have clinically significant findings on laboratory evaluations.\n* Have clinically significant findings on ECG evaluation.\n* History of immunodeficiency diseases, including a positive HIV test result.\n* A positive Hepatitis B surface antigen (HBsAg) or Hepatitis C antibody test result.\n* History of drug or alcohol abuse within the 12 months prior to screening, or evidence of such abuse as indicated by the laboratory assays conducted during the screening.\n* History of tobacco product use within 3 months prior to screening, to be verified by urine cotinine screening.\n* Positive pregnancy test result, if female.\n* Women who are lactating and breastfeeding.","18 Years","60 Years",{"count":85,"type":22},6,[25],"This is an open-label, single-center, phase 1 study to further characterize \\[18F\\]MODAG-009 in Healthy Volunteers (HV). Approximately 6 participants will be enrolled in this study. Each participant will receive a single dose of \\[18F\\]MODAG-009 radiotracer and undergo whole body PET imaging covering up to 10 bed positions to capture the whole body from skull vertex to mid-thigh.",[29],[32,33,36,90,91,92,93,94,34],"MSA","Multiple System Atrophy","Parkinson","Parkinson´s disease","PET tracer","2026-06-02",{"date":97,"type":41},"2026-06-04",{"date":99,"type":41},"2026-05-27",{"date":45,"type":22},{"name":33,"class":47},""]