[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"AC Immune SA\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":138},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,56,86,111],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":26,"conditions":27,"keywords":33,"overallStatus":43,"whyStopped":4,"lastUpdateSubmitDate":44,"lastUpdatePostDateStruct":45,"startDateStruct":48,"completionDateStruct":50,"leadSponsor":52,"locationsCount":55},"100474761","phase-1-a-study-to-assess-the-effects-of-aci-24060-in-alzheimers-disease-and-in-down-syndrome-abate-study-100474761",false,"NCT05462106","A Study to Assess the Effects of ACI-24.060 in Alzheimer's Disease and in Down Syndrome (ABATE Study)","A Phase 1b\u002F2, Multicenter, Adaptive, Double-blind, Randomized, Placebo-controlled Study to Assess the Safety, Tolerability, Immunogenicity, and Pharmacodynamic Effects of ACI-24.060 in Subjects With Prodromal Alzheimer's Disease and in Adults With Down Syndrome (ABATE)","Inclusion Criteria:\n\nStudy Part 1a and Part 1b\n\n1. Age ≥50 and ≤85 years at screening.\n2. Diagnosis of prodromal AD: MCI due to AD according to National Institute on Aging Alzheimer's Association (NIA-AA) criteria.\n3. PET scan at screening consistent with the presence of amyloid pathology.\n4. Clinical Dementia Rating (CDR)-Global Score of 0.5.\n5. Subjects either not taking any marketed treatment for AD or receiving a stable dose of an acetylcholinesterase inhibitor (ACHEI) and\u002For memantine for at least 2 months prior to screening.\n\nStudy Part 2\n\n1. Age ≥35 and ≤50 years at screening (subjects with DS with age ≥35 and ≤39 years may be considered on the condition that there is prior evidence of amyloid results compatible with AD pathology at PET-scan and\u002For in biofluids).\n2. Male or female subjects with DS with a cytogenetic diagnosis being either trisomy 21 or complete unbalanced translocation of chromosome 21.\n3. PET scan at screening consistent with the presence of amyloid pathology.\n4. Mild to moderate intellectual disability as per Diagnostic and Statistical Manual of Mental Disorders (DSM-5) classification.\n5. Subjects must have a study partner who has direct and regular contact, at least 10 hours per week, with the subject and who is able to provide reliable answers to questions related to the subject, according to the study investigator.\n\nExclusion Criteria:\n\n1. Any unstable and\u002For clinically significant medical condition likely to hamper the evaluation of safety and\u002For efficacy of the study treatment (eg, moderate and\u002For severe untreated obstructive sleep apnea, clinically significant reduction in serum B12 or folate levels, clinically significant abnormalities of thyroid function, stroke, or other cerebrovascular conditions), as per investigator's judgement.\n2. DSM-5 criteria for substance use disorders drug or alcohol abuse or dependence (with the exception of tobacco use disorder) currently met within the past 5 years.\n3. History or presence of uncontrolled seizures. If there is a history of seizures, they must be well controlled, with no occurrence of seizures in the 2 years before study screening. The use of antiepileptic medications is permitted.\n4. Concomitant or history of clinically significant and\u002For unstable psychiatric or neurologic disorder other than those considered to be related to AD (eg, head injury with loss of consciousness, symptomatic stroke, Parkinson's disease, severe carotid occlusive disease, transient ischemic attacks, hemorrhagic and\u002For non-hemorrhagic stroke). Subjects with a history of major depressive disorder may be included if they have been free of major episodes for at least 1 year before screening.\n5. History of meningitis or meningoencephalitis.\n6. History of moderate or severe traumatic brain injury.\n7. History or presence of inflammatory neurological disorders.\n8. History or presence of immunological or autoimmune disorders.\n9. History of severe allergic reaction (eg, anaphylaxis) including, but not limited to severe allergic reaction to previous vaccines, foods, and\u002For medications.\n10. Significant risk of suicide, defined using the C-SSRS as the subject answering \"yes\" to suicidal ideation questions 4 or 5 or answering \"yes\" to suicidal behavior within the past 12 months.\n11. MRI scan at screening showing a single area of cerebral vasogenic edema, superficial siderosis, or evidence of a previous macro-hemorrhage or showing more than 4 cerebral microhemorrhages (regardless of their anatomical location or diagnostic characterization as \"possible\" or \"definite\"). Evidence of space occupying lesions other than benign meningioma of less than 1 cm diameter, more than 2 lacunar infarcts, or 1 single infarct larger than 1 cm in diameter. Screening MRI scan showing structural evidence of alternative pathology not consistent with AD and is considered to be at the origin of subject's symptoms.\n12. Deviations from normal values for hematologic parameters, liver function tests, and other biochemical measures, judged to be clinically significant by the investigator.\n13. Subjects with a positive Human Immunodeficiency Virus (HIV-1 and 2) test at screening.\n14. Subjects with clinical or laboratory evidence of active hepatitis B or C at screening (eg, HBV or HCV antigens).\n15. Subjects with positive syphilis serology consistent with active syphilis at screening.\n16. Subjects with presence of antibody titers related to immunological or autoimmune disorders at screening.\n17. MRI examination cannot be done for any reason, including but not limited to metal implants contraindicated for MRI and\u002For severe claustrophobia.\n18. Any contraindication for PET scan imaging.\n19. Any contraindication to lumbar puncture in subjects undergoing this procedure (note: lumbar puncture is optional in subjects with DS).\n20. Previous treatment with ACI-24 or any other active immunotherapy against AD at any time in the past unless there is firm evidence that the subject received placebo only and the placebo formulation is not expected to induce any specific immune response.\n21. Previous treatment with any investigational and\u002For marketed passive immunotherapy against AD within 6 months before screening or 5 half-lives, whichever is longer, unless there is firm evidence that the subject received placebo only.\n22. Ongoing treatment with any approved anti-amyloid passive immunotherapy for Alzheimer's disease.\n23. Use of acetylcholinesterase inhibitor or glutamatergic drugs (eg, memantine, topiramate, lamotrigine) if not on stable dose for at least 2 months before screening.\n24. Any vaccine, either live or not, including but not limited to influenza or COVID-19 vaccine, received within 4 weeks before randomization.\n25. Subjects with treated hypothyroidism not on a stable dose of replacement medication for at least 2 months before screening and having clinically significant abnormal serum T4 and\u002For thyroid stimulating hormone at screening.\n26. Subjects undergoing lumbar puncture and being treated with any anticoagulants or antiplatelet drugs, except aspirin at doses of 100 mg daily or lower.\n27. Use of antidepressants (other than selective serotonin reuptake inhibitors\u002Fserotonin-norepinephrine reuptake inhibitors at stable dose); typical antipsychotics; γ-aminobutyric acid agonists (eg, gabapentin); or stimulants (eg, methylphenidate, modafinil). Stable doses of atypical antipsychotics or benzodiazepines are only allowed if this is not considered to influence the safety and the efficacy of the study treatment according to the site investigator and the sponsor medical monitor.\n28. Chronic use of opioid analgesics. A limited treatment duration for acute conditions until 24 hours before cognitive assessment is allowed.\n29. Current use of immunosuppressant or immunomodulating drugs or their use within the 6 months before study screening. Current use of oral steroids or their use within the 3 months before study screening.\n\n    Additional Exclusion Criteria in Study Part 2\n\n    The following are exclusion criteria at the time of randomization but will not be considered as exclusionary after treatment assignment:\n30. Clinical diagnosis of AD dementia in DS as per International Classification of Diseases 10 (ICD-10).\n31. DSQIID \\>20.\n32. Intelligence quotient score \\\u003C40 (KBIT-2).","ALL","35 Years","85 Years",{"count":20,"type":21},304,"ESTIMATED","INTERVENTIONAL",[24,25],"PHASE1","PHASE2","The purpose of this study is to assess the safety, tolerability, immunogenicity and pharmacodynamic effects of ACI-24.060 in subjects with prodromal Alzheimer's disease and in non-demented adults with Down syndrome.",[28,29,30,31,32],"Amyloid Plaque","Beta-Amyloid","DSAD","Prodromal Alzheimer's Disease","Alzheimer's Disease",[34,35,36,28,29,37,38,39,40,41,30,42],"Dementia","Brain Diseases","Central Nervous System Diseases","Down syndrome","Immunogenicity","active immunotherapy","immune response","anti-amyloid therapy","Alzheimer's disease","RECRUITING","2026-05-27",{"date":46,"type":47},"2026-05-29","ACTUAL",{"date":49,"type":47},"2022-06-21",{"date":51,"type":21},"2029-04",{"name":53,"class":54},"AC Immune SA","INDUSTRY",26,{"id":57,"slug":58,"hasResults":11,"nctId":59,"briefTitle":60,"officialTitle":61,"acronym":4,"eligibilityCriteria":62,"healthyVolunteers":63,"sex":16,"minAge":64,"maxAge":65,"enrollmentInfo":66,"targetDuration":4,"studyType":22,"phases":68,"briefSummary":69,"conditions":70,"keywords":72,"overallStatus":43,"whyStopped":4,"lastUpdateSubmitDate":77,"lastUpdatePostDateStruct":78,"startDateStruct":80,"completionDateStruct":82,"leadSponsor":84,"locationsCount":85},"100628558","phase-1-a-study-investigating-the-safety-absorption-elimination-and-the-effect-on-the-immune-system-of-aci-19764-in-healthy-participants-100628558","NCT07463196","A Study Investigating the Safety, Absorption, Elimination, and the Effect on the Immune System of ACI-19764 in Healthy Participants","A Single-Center, Double-Blind, Randomized, Placebo-Controlled Phase 1 Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single- and Multiple-Ascending Doses of ACI-19764 in Healthy Participants","Inclusion Criteria:\n\n1. Signed informed consent in a language understandable to the participant prior to any study-mandated procedure.\n2. Healthy male (Parts A and B) or female (Part B) aged between 18 and 65 years (inclusive) at screening.\n3. Body mass index of 18.0 to 29.9 kg\u002Fm2 (inclusive) at screening.\n4. Ability to communicate well with the investigator, and to understand and comply with the study requirements.\n5. Systolic blood pressure (SBP) 90-140 mmHg, diastolic blood pressure (DBP) 45-90 mmHg, and pulse rate 40 to 100 beats per minute (bpm) (all inclusive), measured on either arm (same arm used for both screening and admission), after 5 min in the supine position at screening and admission.\n6. 12-lead safety ECG: QT interval corrected for HR using Fridericia's formula (QTcF) \\\u003C450 ms for male participants and \\\u003C470 ms for female participants, QRS interval \\\u003C120 ms, PR interval \\\u003C220 ms, and HR 40 to 100 bpm (inclusive), and without clinically relevant abnormalities, measured after 5 min in the supine position at screening and admission.\n7. Fertile male participants (defined as physiologically capable of conceiving a child according to the investigator's judgment) must agree to refrain from fathering a child and:\n\n   * Be sexually abstinent with women of childbearing potential (WoCBP) or use condoms during sexual intercourse with WoCBP from (first) study treatment administration up to at least 90 days after (last) study treatment administration. Male participants must advise their WoCBP partners consistently to use a highly effective method of contraception with a failure rate of \\\u003C1% per year.\n   * Do not donate sperm from (first) study treatment administration up to at least 90 days after (last) study treatment administration.\n8. Part B only: Female participants must have a negative serum pregnancy test at screening and a negative urine pregnancy test at admission and a follicle-stimulating hormone (FSH) test must be performed at screening. WoCBP must agree to consistently and correctly use (from screening, during the entire study, and for at least 30 days after the last study treatment administration) a highly effective method of contraception with a failure rate of \\\u003C1% per year, be sexually inactive, or have a vasectomized partner with a post-vasectomy semen analysis negative for sperm at least 6 months before screening. If a hormonal contraceptive is used, it must be initiated at least 1 month before the first study treatment administration and should be used in conjunction with barrier methods. WoCBP must agree to not donate eggs from screening until at least 30 days after the last study treatment administration.\n9. Part B only: WoNCBP must be postmenopausal or have documented previous bilateral salpingectomy, bilateral salpingo-oophorectomy or hysterectomy, or with premature ovarian failure (confirmed by a specialist), XY genotype, uterine agenesis.\n\nExclusion Criteria:\n\n1. Known hypersensitivity to any excipient of the ACI-19764 formulations.\n2. Known clinically relevant hypersensitivity or allergy to any therapeutic treatment (including non-steroidal anti-inflammatory drugs \\[NSAIDs\\], or nucleotide-binding oligomerization domain-like receptor family pyrin domain-containing 3 \\[NLRP3\\] inhibitors), vaccines, cosmetics, natural rubber or latex and\u002For food.\n3. Clinically relevant findings on the physical examination at screening or on Day -1.\n4. Clinically relevant findings in clinical laboratory tests\n5. Clinically relevant history or presence of rhythm disorders, congestive heart failure, or structural heart disease.\n6. History or presence of clinically relevant surgical intervention which, in the opinion of the investigator, could potentially interfere with the safety\u002Ftolerability and\u002For absorption, distribution, metabolism, and excretion (ADME) of the study treatment.\n7. History or presence of acute, ongoing, recurrent, or chronic clinically relevant diseases which, in the opinion of the investigator, could potentially interfere with the assessment of safety\u002Ftolerability and\u002For ADME of the study treatment.\n8. History or current acute or chronic pulmonary pathology including but not limited to chronic obstructive pulmonary disease (COPD), asthma, and recurrent lung infections.\n9. Lifetime history of suicide attempt (including active attempt, interrupted attempt or aborted attempt) or suicidal ideation in the past 6 months according to the C-SSRS at screening.\n10. History of cancer within the past 5 years other than treated squamous cell carcinoma, basal cell carcinoma, and melanoma in situ, or in-situ prostate cancer, in-situ cervix carcinoma, or in-situ breast cancer which have been fully removed and are considered cured.\n11. Previous unexplained history of recurrent pre-syncope or syncope with no clear provoking features or syncope in the context of medical investigations that is likely to complicate interpretation of the safety of the drug in the opinion of the Investigator.\n12. Veins unsuitable for intravenous (i.v.) puncture on both arms.\n13. Participation in a clinical study involving study treatment administration within 3 months (or within 5 half-lives before screening, whichever is longer) prior to (the first) study treatment administration or in more than 3 clinical studies within 1 year prior to (the first) study treatment administration.\n14. History or clinical evidence of alcoholism or drug abuse within the 3-year period prior to screening.\n15. Consumption of \\>14 units of alcohol per week (females) or \\>21 units per week (males).\n16. Excessive caffeine consumption.\n17. Nicotine consumption from 3 months prior to (first) study treatment administration, checked at screening and on Day -1.\n18. Loss (including donation) of 450 mL or more of blood or blood products within 2 months prior to (the first) study treatment administration.\n19. Positive results from serum\u002Furine drug or alcohol screen test at screening or on Day -1.\n20. Positive hepatitis B and\u002For C serology results, except for vaccinated participants or those with past but resolved hepatitis, at screening.\n21. Positive human immunodeficiency virus (HIV) serology results at screening.\n22. Any circumstances or conditions which, in the opinion of the investigator, may affect full participation in the study or compliance with the protocol.\n23. Legal incapacity or limited legal capacity at screening.\n24. Treatment or intended treatment with any prescribed medications within 2 weeks prior to (first) study treatment administration, except for contraceptives (including hormonal contraceptive devices) in female participants (Part B only), and\u002For over-the-counter (OTC) medications (including herbal medicines such as St John's Wort, homeopathic preparations, vitamins, and minerals) within 1 week prior to (first) study treatment administration. Analgesia with paracetamol is acceptable (but not NSAIDs or aspirin \\>75 mg per day), unless for the short-term treatment of post lumbar puncture (LP) headache.\n25. Any immunosuppressive therapies within 2 months prior to first study treatment administration.\n26. Any biological compound for research or medical reasons within 12 months prior to (first) study treatment administration.\n27. Any relevant bacterial, viral, fungal, or protozoal infection that manifested within the last 6 weeks prior to screening and\u002For an ongoing relevant bacterial, viral, fungal, or protozoal infection, as judged by the investigator, and\u002For evidence of immune dysfunction based on laboratory tests at screening. If mild infections occur during screening causing a rise in C-reactive protein (CRP), the participant should not be included until this has normalized.\n28. Receipt of vaccine within 5 weeks prior to admission.\n29. Any medical history of an active tuberculosis (TB) infection, positive test result for latent TB in the last 2 years, or any contact with TB-positive individuals in the last 4 weeks prior to screening.\n30. Potential anticipated lack of compliance with study assessments and visit schedule.\n31. Planned hospitalization (other than for study assessments) or surgery during the study.\n32. Part A Food effect cohort only: Inability or unwillingness to completely consume the high-fat breakfast prior to study treatment administration.\n33. Part B only: Pregnant or lactating women.\n34. Part B (for those undergoing LP): Contraindications for LP including, but not limited to space-occupying lesions with mass effect or raised intracranial pressure, posterior fossa mass, anticoagulant or antiplatelet medications, coagulopathy, thrombocytopenia (\\\u003C150×109\u002FL), congenital spine abnormality, skin infection at the LP site or tattoo covering puncture site.\n35. Part B (for those undergoing LP): Lower back pain at the time of the study or history of recurrent headaches in the last 6 months (more than 4 days a month of headaches that limit normal daily activity)",true,"18 Years","65 Years",{"count":67,"type":21},78,[24],"The main purposes of this study are:\n\n* to investigate the safety and tolerability of ACI-19764 when it is administered to healthy participants\n* to determine how quickly and to what extent ACI-19764 is absorbed, transported, metabolized, and excreted by the body (fasted and after a meal)\n* to determine the effect of ACI-19764 on specific markers in the blood that are part of the immune system\n\nThe effects of ACI-19764 will be compared with the effects of a placebo. ACI-19764 is a brain-penetrant NLRP3 inhibitor.\n\nThe study consists of 2 parts, Part A (SAD, single ascending dose) and Part B (MAD, multiple ascending doses). Participants in Part A will receive the study compound once and participants in Part B will receive the study compound multiple times (daily over 14 days). Each of these 2 study parts will be divided into different groups of participants to test different doses of ACI-19764.",[71],"Healthy Participants",[73,71,74,75,76],"Phase 1","SAD\u002FMAD","NLRP3 inhibitor","Pharmacokinetics","2026-03-05",{"date":79,"type":47},"2026-03-11",{"date":81,"type":47},"2026-01-28",{"date":83,"type":21},"2026-08",{"name":53,"class":54},1,{"id":87,"slug":88,"hasResults":11,"nctId":89,"briefTitle":90,"officialTitle":91,"acronym":4,"eligibilityCriteria":92,"healthyVolunteers":63,"sex":16,"minAge":93,"maxAge":4,"enrollmentInfo":94,"targetDuration":4,"studyType":22,"phases":96,"briefSummary":98,"conditions":99,"keywords":4,"overallStatus":43,"whyStopped":4,"lastUpdateSubmitDate":103,"lastUpdatePostDateStruct":104,"startDateStruct":106,"completionDateStruct":108,"leadSponsor":110,"locationsCount":85},"100584619","early-phase-1-18faci-15916-pet-in--synucleinopathies-100584619","NCT06891703","[18F]ACI-15916 PET in α-synucleinopathies","Phase 1 Study to Evaluate [18F]ACI-15916 as a Potential PET Radioligand for Imaging α-synuclein Deposits in the Brain of Patients With Suspected α-synuclein Pathology Compared With Healthy Volunteers","Inclusion Criteria for all Participants:\n\n1. Subject is able to provide written informed consent, which must be obtained before any assessment is performed.\n2. Subjects must be able to understand and be willing to comply with study procedures, restrictions, and requirements.\n3. Body mass index is \\> 18 and \\\u003C 31 kg\u002Fm2 and Bodyweight ≥ 50 kg and ≤ 100 kg.\n4. Female participants must not be of childbearing potential or agree to use highly effective methods of contraception.\n5. For subjects receiving arterial cannulation, an adequate circulation to the hand for safe placement of arterial line (as determined by Allen's test).\n\n   Additional Inclusion Criteria for Healthy Volunteers:\n6. Males and females aged ≥ 20 at the time of signing the informed consent.\n7. Normal MRI and DAT PET or SPECT (except for Part 4 participants), as judged by the investigator.\n8. The subject is, in the opinion of the investigator, generally healthy based on the assessment of medical history, physical examination, vital signs, ECG, and the results of the hematology, clinical chemistry, urinalysis, serology, and other laboratory tests.\n9. No family history of α-synucleinopathy, including PD, or other early-onset neurological disease associated with dementia.\n10. No personal history of clinically significant neurologic and\u002For psychiatric disorders.\n11. Have a Montreal Cognitive Assessment (MoCA) score ≥ 26\n12. No cognitive impairment as judged by the PI or delegated physician.\n\n    Additional Inclusion Criteria for Participants with α-synucleinopathies:\n13. Males and females aged ≥ 40 at the time of signing the informed consent.\n14. Subjects diagnosed with any of the following:\n\n    * Idiopathic PD based on MDS criteria\n    * PD with genetic risk factor (except some mutations as mentioned in exclusion criteria)\n    * Dementia with Lewy bodies (DLB)\n    * Diagnosis of possible or probable Multiple System Atrophy (MSA)\n15. Evidence of dopamine transporter deficit on DAT PET or SPECT imaging performed either as part of Screening or previously acquired (if not older than 6 months) and of good quality as judged by the investigator.\n16. Medications taken for symptomatic treatment of α-synucleinopathy must be maintained on a stable dosage regimen for at least 30 days before the Screening Visit.\n\nExclusion Criteria for all Participants:\n\n1. Female subjects pregnant, lactating or breastfeeding.\n2. Presence of psychiatric symptoms that may interfere with the objectives of the study, as judged by the investigator.\n3. Clinically significant concomitant disease or condition within 6 months prior to screening, that could interfere with the conduct of the study, or that would, in the opinion of the investigator, pose an unacceptable risk to the participant, or compromise the scientific quality of the study.\n4. History of brain surgery or any neurosurgical procedures. Subject has received treatment with a drug, antibody or vaccine targeting α-synuclein.\n5. Known or suspected drug, alcohol or other abuse, or positive urine drug screen which may interfere with the study objective, as judged by the investigator.\n6. History of severe allergy\u002Fhypersensitivity or ongoing allergy\u002Fhypersensitivity as judged by the investigator.\n7. Subject is involved in the planning and\u002For conduct of the study (i.e. part of the study team)\n8. History of clinically significant cardio-or cerebrovascular, pulmonary, renal, hepatic, neurological, mental or gastrointestinal disorder or any other major disorder that may interfere with the objectives of the study, as judged by the investigator.\n9. History of and\u002For screening brain MRI scan (except for Part 4 subjects) indicative of, clinically significant abnormality including but not limited to prior haemorrhage or infarct or \\>3 lacunar infarcts, except changes consistent with α-synucleinopathies for PD, MSA, DLB patients.\n10. Subjects being treated with any anticoagulants or antiplatelet drugs, except aspirin at doses of 100 mg daily or lower within 2 weeks of the planned arterial cannula placement (if performed) for either the baseline or retest imaging.\n11. Screening supine blood pressure \\> 150 mm Hg (systolic) or \\> 90 mm Hg (diastolic), following at least 5 minutes of supine rest. If blood pressure (BP) is \\> 150 mm Hg (systolic) or \\> 90 mm Hg (diastolic), the BP should be repeated two more times and the average of the three BP values should be used to determine the subject's eligibility.\n12. Electrocardiographic (ECG) abnormalities of clinical significance as judged by the investigator. Screening supine 12-lead ECG demonstrating QTc \\> 450 msec at Screening.\n13. Any contraindications to obtaining a brain MRI (except for Part 4 subjects), DaT-SPECT (except for Part 4 subjects) or PET (e.g., claustrophobia unresponsive to reassurance or low dose of an anxiolytic agent, metal implants not compatible with MRI or known hypersensitivity to the active substance or to any of the excipients) and ability to tolerate lying in the scanner for up to \\~180 minutes.\n14. Previous exposure to radiation for medical, scientific or other reasons which could have a high negative impact on the research subject, as judged by the investigator.\n15. Treatment with any other investigational therapy within 5 drug elimination half-lives or 30 days (whichever is longer) prior to inclusion in the study.\n\n    Additional Exclusion Criteria for Healthy Volunteers:\n16. Current use of CNS active drugs, including antidepressant or neuroleptic medications is not permitted, anti-inflammatory drugs or sleep medications may be allowed at the discretion of the investigator.\n17. History of neurological disease\u002Fcondition that may interfere with the objectives of the study, as judged by the investigator.\n\n    Additional Exclusion Criteria for Participants with α-synucleinopathy:\n18. Medical history indicating a Parkinsonian syndrome other than idiopathic PD, including but not limited to, progressive supranuclear palsy, drug-induced parkinsonism, essential tremor, vascular parkinsonism, primary dystonia or corticobasal syndrome (CBS).\n19. Known carriers of certain familial PD gene mutations (PRKN, PINK1, DJ1, LRRK2), based on previous source documentation.","20 Years",{"count":95,"type":21},46,[97],"EARLY_PHASE1","The goal of this clinical trial is to test whether we can reliably and safely measure the accumulation of pathological protein α-synuclein \\[involved in some diseases such as Parkinson's disease, Lewy body dementia and Multiple System Atrophy (MSA), collectively named α-synucleinopathies\\] using a new positron emission tomography (PET) tracer called \\[18F\\]ACI-15916. Both healthy people and people with (suspected) α-synuclein pathology will participate to this trial.\n\nThe main questions it aims to answer are:\n\n* whether \\[18F\\]ACI-15916 is safe and well tolerated when injected into participants\n* whether \\[18F\\]ACI-15916 reliably detects α-synuclein in the brain using PET technique.\n* whether there are differences in the amount of this protein between people with diseases related to α-synuclein accumulation in the brain and people without these diseases.\n\nParticipants will:\n\n* Visit the clinic to consent to their participation and to ensure they are eligible \\[physical and neurological examinations, questionnaires, blood and urine tests, ECG and in some cases a MRI and a PET scan with a licensed tracer (\\[18F\\]FE-PE2I) to confirm or not the disease\\].\n* Visit the clinic to receive the tracer \\[18F\\]ACI-15916 intravenously and be scanned in a PET scanner, during which blood will be collected (and optionally spinal fluid).\n* Receive a phone call from the clinic 1 week after the PET scan to report any symptoms and side-effects that they may be having.\n\nSome of the participants may be asked to come again to the clinic for a second PET scan with \\[18F\\]ACI-15916, allowing the researchers to determine if the measurements with the first PET scan are stable and reproducible.\n\nSome of the participants will participate in a specific part of the study to evaluate the distribution of the PET ligand in the whole body, with a similar visit schedule.",[100,101,102],"Parkinson's Disease (PD)","Multiple System Atrophy (MSA)","Dementia With Lewy Bodies (DLB)","2025-11-18",{"date":105,"type":47},"2025-11-19",{"date":107,"type":47},"2025-03-20",{"date":109,"type":21},"2026-03",{"name":53,"class":54},{"id":112,"slug":113,"hasResults":11,"nctId":114,"briefTitle":115,"officialTitle":116,"acronym":4,"eligibilityCriteria":117,"healthyVolunteers":63,"sex":16,"minAge":118,"maxAge":119,"enrollmentInfo":120,"targetDuration":4,"studyType":22,"phases":122,"briefSummary":123,"conditions":124,"keywords":4,"overallStatus":43,"whyStopped":4,"lastUpdateSubmitDate":130,"lastUpdatePostDateStruct":131,"startDateStruct":133,"completionDateStruct":135,"leadSponsor":137,"locationsCount":85},"100584620","early-phase-1-18faci-19626-pet-in-tdp-43-proteinopathies-100584620","NCT06891716","[18F]ACI-19626 PET in TDP-43 Proteinopathies","Phase 1 Study to Evaluate [18F]ACI-19626 as a Potential PET Radioligand for Imaging TDP-43 Inclusions in the Brain of Patients With Suspected TDP-43 Proteinopathies Compared With Healthy Controls","Inclusion Criteria for all Participants:\n\n* Subject is able to provide written informed consent (IC), which must be obtained before any assessment is performed.\n* Female subjects must not be of childbearing potential, or if they are of childbearing potential to agree to use reliable contraception method(s) and not donate eggs for 30 days after the PET scan. Subjects without documentation of non-childbearing potential will perform serum pregnancy testing at screening and urine pregnancy test before the PET scan. 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\u002For uterus) or another cause as determined by the PI (e.g., Müllerian agenesis). Women of childbearing potential must commit to remain abstinent (refrain from heterosexual intercourse) or use a reliable form of birth control (e.g. a barrier, hormonal contraception method or intrauterine device), during the study and until 30 days after the last PET scan. Periodic abstinence (e.g., calendar, ovulation, symptothermal, or postovulation methods) and withdrawal are not adequate methods of contraception. Women of childbearing potential must commit to not donate ovum during the study and until 30 days after the last PET scan.\n* Male subjects with their partners of childbearing potential must commit to the use of a barrier method of contraception during the study and until 90 days after the last PET scan.\n* Male subjects must commit to not donate sperm during the study and until 90 days after the last PET scan.\n* Willing and able to cooperate with study procedures.\n* Ability to tolerate lying in the scanner for up to 90 minutes without excessive movements sufficient to cause significant motion artifact on the PET scans, or if necessary up to 120 minutes with a break.\n* For subjects receiving arterial cannulation, adequate circulation to the hand for safe placement of arterial line and coagulation (International Normalized Ratio \\[INR\\], Prothrombin Time \\[PT\\] and Partial Thromboplastin Time \\[PTT\\]).\n\nAdditional Inclusion Criteria for Healthy Controls:\n\n* Males and females aged 40-70 years.\n* Healthy with no clinically relevant finding on physical and neurological examination at Screening and upon reporting to the clinic for the \\[18F\\]ACI-19626 Imaging Visit.\n* No family history of TDP-43 proteinopathies, including FTD, ALS, or other early-onset neurological disease associated with dementia and\u002For movement disorders.\n* No personal history of clinically significant neurological and\u002For psychiatric disorders.\n* No evidence of neurodegeneration or other neurological pathology on magnetic resonance imaging (MRI) performed either as part of Screening or on previously acquired MRI scan (within 6 months prior to signing consent).\n* Montreal Cognitive Assessment (MoCA) score ≥ 26.\n* No cognitive or behavioural impairment as judged by the PI.\n\nAdditional Inclusion Criteria for Participants with TDP-43 proteinopathies:\n\n* Males and females aged ≥ 40 years.\n* Subjects diagnosed with any of the following: GRN, C9Orf72 or other mutation carriers with the CDR® plus NACC FTLD-GS of ≥ 0.5; sporadic probable behavioral FTD per International consensus criteria or primary progressive aphasia, with or without clinical or electrophysiological indications of MND; ALS meeting the El Escorial criteria of probable or possible ALS; Other neurodegenerative diseases, e.g. AD or suspected LATE pathology\n* Confirmed genetic status for the subjects with genetic FTD, FTD-MND or ALS (e.g. GRN, C9orf72 or other mutations)\n* For sporadic FTD \u002F FTD-MND subjects: brain MRI consistent with a diagnosis of FTD, with no evidence of focal disease to account for the subject's neurological, cognitive or behavioral symptoms.\n\nExclusion Criteria for All Participants:\n\n* Current or prior history of any alcohol or drug abuse in the past 2 years.\n* Laboratory tests with clinically significant abnormalities and\u002For clinically significant unstable medical condition.\n* Known history of hypersensitivity, including hypersensitivity to the active substances used for \\[18F\\]ACI-19626 or derivatives, or to any of the associated excipients.\n* Prior participation in other research protocols or clinical care during the past year that would result in radiation exposure to an effective radiation dose exceeding the acceptable annual limit (including the procedures in this clinical protocol).\n* Pregnant or lactating.\n* Evidence of clinically significant gastrointestinal, cardiovascular, hepatic, renal, hematological, neoplastic, endocrine, alternative neurological, immunodeficiency, pulmonary, or other disorder or disease.\n* Unsuitable veins for repeated venipuncture.\n* 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.\n* Treatment with any antihemostasis medication (e.g., warfarin, heparin, thrombin inhibitors, Factor Xa inhibitors, streptokinase, urokinase, tissue plasminogen activators) within 2 weeks of the planned arterial cannula placement (if performed) of either the baseline or retest imaging.\n* Anaemia (for subjects undergoing arterial cannulation) considered clinically significant by the PI\n* Coagulopathies\n* Loss or donation of blood over 500 mL within four months prior to study visits for subjects undergoing arterial cannulation\n* Subject has received an investigational drug within the last 30 days or 5 half-lives prior to the screening assessments, whichever is longer unless there is documented evidence that the subject was treated with placebo only.\n\nAdditional Exclusion Criteria for Participants with TDP-43 proteinopathies:\n\n* Prior participation in DMT clinical trials which could interfere with the TDP-43 protein itself or its metabolism, including but not limited to gene therapy, unless there is documented evidence that the subject was treated with placebo only.\n* MRI scan showing structural evidence of alternative pathology not consistent with TDP-43 proteinopathies which could cause the subject's symptoms.\n* Mutations with known absence of TDP-43 pathology, e.g. SOD1 or FUS.","40 Years","70 Years",{"count":121,"type":21},45,[97],"The goal of this clinical trial is to test whether we can reliably and safely measure the accumulation of pathological protein TDP-43 \\[involved in rare forms of dementia such as frontotemporal dementia (FTD) and in amyotrophic lateral sclerosis (ALS)\\] using a new positron emission tomography (PET) tracer called \\[18F\\]ACI-19626. Both healthy people and people with (suspected) TDP-43 accumulation will participate to this trial.\n\nThe main questions it aims to answer are:\n\n* whether \\[18F\\]ACI-19626 is safe and well tolerated when injected into participants\n* whether \\[18F\\]ACI-19626 reliably detects abnormal TDP-43 in the brain using PET technique.\n* whether there are differences in the amount of this protein between people with diseases related to TDP-43 accumulation in the brain and people without these diseases.\n\nParticipants will:\n\n* Visit the clinic to consent to their participation and to ensure they are eligible (physical and neurological examinations, questionnaires, blood and urine tests, ECG and MRI in some cases).\n* Visit the clinic to receive the tracer \\[18F\\]ACI-19626 intravenously and be scanned in a PET scanner, during which blood will be collected.\n* Receive a phone call from the clinic 2 to 4 days after the PET scan to report any symptoms and side-effects that they may be having.\n\nSome of the participants may be asked to come again to the clinic for a second PET scan, allowing the researchers to determine if the measurements with the first PET scan are stable and reproducible.",[125,126,127,128,129],"Frontotemporal Dementia (FTD)","Amyotrophic Lateral Sclerosis (ALS)","TDP-43 Proteinopathies","Suspected Limbic Predominant Age-related TDP-43 Encephalopathy (LATE)","Alzheimer's Disease (AD)","2025-03-18",{"date":132,"type":47},"2025-03-24",{"date":134,"type":47},"2025-01-21",{"date":136,"type":21},"2026-11",{"name":53,"class":54},""]