[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07599670":3,"trial-entities:NCT07599670":258,"trial-summary:NCT07599670":261},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":20,"study_type":22,"primary_purpose":23,"phases":24,"enrollment_info":27,"interventions":30,"primary_outcomes":61,"secondary_outcomes":123,"sex":124,"minimum_age":125,"maximum_age":126,"healthy_volunteers":127,"eligibility_criteria":128,"std_ages":145,"locations":148,"central_contacts":247,"overall_officials":252,"references":256,"see_also_links":257},"NCT07599670","M25-804","A Study to Assess the Safety and Effects of ABBV-1758 Following Subcutaneous or Intravenous Injections in Participants With Alzheimer's Disease","A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate Safety, Efficacy, Pharmacokinetics, and Pharmacodynamics of ABBV-1758 in Participants With Alzheimer's Disease","RECRUITING","2030-10","2026-06","2026-06-23","2026-05-15","AbbVie","INDUSTRY",true,"Alzheimer's disease (AD) is a progressive, irreversible neurological disorder and is the most common cause of dementia in the elderly population. Clinical symptoms of the disease may begin with occasional forgetfulness such as misplacement of items, forgetting important dates or events, and may progress to noticeable memory loss, increased confusion and agitation, and eventually, loss of independence and non-responsiveness. The purpose of this study is to test how safe ABBV-1758 is, how well it works, how the body processes it and what effects it has on the body.\n\nABBV-1758 is an investigational drug being developed for the treatment of Alzheimer's disease. This study is conducted in 3 stages. Stage A is a multiple ascending dose study with a 1 in 5 chance (4:1 randomization) that participants are assigned to receive placebo. Stage B is a dose expansion phase, also using 4:1 randomization for ABBV-1758 or placebo. Stage C enrolls Japanese and Chinese participants with the same randomization scheme. Approximately 210 participants will be enrolled at about 55 sites in the United States, China, and Japan.\n\nParticipants will receive intravenous (IV) or subcutaneous (SC) doses of ABBV-1758 or placebo once every 4 weeks (Q4W) for 24 weeks and will be followed for additional 12 weeks in the Follow-up Period. Participants will have the option of participating in a 12-month, blinded Extension Period receiving ABBV-1758 or placebo based on amyloid PET results.\n\nThere may be higher treatment burden for participants in this trial compared to their standard of care due to study procedures. Participants will attend regular visits during the study at a hospital or clinic. The safety of the treatment will be checked by medical assessments, blood tests, and completing questionnaires.",null,[19],"Alzheimer's Disease",[19,21],"ABBV-1758","INTERVENTIONAL","TREATMENT",[25,26],"PHASE1","PHASE2",{"count":28,"type":29},210,"ESTIMATED",[31,41,50,56],{"type":32,"name":21,"description":33,"armGroupLabels":34},"DRUG","Intravenous (IV) or Subcutaneous (SC)",[35,36,37,38,39,40],"Stage A-ABBV-1758 Dose D","Stage B- ABBV-1758 - Expanded Cohort 1","Stage B- ABBV-1758- Expanded Cohort 2","Stage C- ABBV-1758 - Japanese Cohort 1","Stage C- ABBV-1758- Japanese Cohort 2","Stage C- ABBV-1758-Chinese Cohort",{"type":32,"name":42,"description":33,"armGroupLabels":43},"Placebo for ABBV-1758",[44,45,46,47,48,49],"Placebo for ABBV-1758 - Expanded Cohort 1","Placebo for ABBV-1758 - Japanese Cohort 1","Placebo for ABBV-1758 Dose D","Placebo for ABBV-1758- Chinese Cohort","Placebo for ABBV-1758- Expanded Cohort 2","Placebo for ABBV-1758- Japanese Cohort 2",{"type":32,"name":21,"description":51,"armGroupLabels":52},"Subcutaneous (SC)",[53,54,55],"Stage A-ABBV-1758 Dose A","Stage A-ABBV-1758 Dose B","Stage A-ABBV-1758 Dose C",{"type":32,"name":42,"description":51,"armGroupLabels":57},[58,59,60],"Placebo for ABBV-1758 Dose A","Placebo for ABBV-1758 Dose B","Placebo for ABBV-1758 Dose C",[62,66,69,72,75,78,81,85,88,91,94,97,100,102,105,108,111,114,117,120],{"measure":63,"description":64,"timeFrame":65},"Percentage of Participants Experiencing Adverse Events (AEs)","An adverse event (AE) is defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with the treatment. The investigator assesses the relationship of each event to the use of study drug.","Up to approximately 40 weeks",{"measure":67,"description":68,"timeFrame":65},"Percentage of Participants with Abnormal Change from Baseline in Clinical Laboratory Test Results","Number of participants with abnormal change in clinical laboratory test results like hematology will be assessed.",{"measure":70,"description":71,"timeFrame":65},"Percentage of Participants With Amyloid-Related Imaging Abnormalities (ARIA)","Amyloid related imaging abnormalities represent a spectrum of magnetic resonance imaging findings primarily observed in participants undergoing treatment with anti-amyloid therapies.",{"measure":73,"description":74,"timeFrame":65},"Percentage of Participants with Abnormal Change From Baseline in Vital Sign Measurements","Number of participants with abnormal change from baseline in vital sign measurements like systolic and diastolic blood pressure will be assessed.",{"measure":76,"description":77,"timeFrame":65},"Percentage of Participants with Abnormal Change From Baseline in Electrocardiograms (ECGs) Parameters","12-lead resting ECGs will be recorded. Parameters include heart rate, PR interval, QT interval, QRS duration, and QT interval corrected using Fridericia's formula (QTcF).",{"measure":79,"description":80,"timeFrame":65},"Percentage of Participants Experiencing Any Suicidal Ideation or Suicidal Behavior As Assessed by Columbia-Suicide Severity Rating Scale (C-SSRS)","The C-SSRS is a clinician-rated instrument that reports the severity of both suicidal ideation and behavior, with a higher score denoting more severe suicidal ideation and behavior.",{"measure":82,"description":83,"timeFrame":84},"Stage A, B, and C: Change from Baseline in Brain Amyloid Load","Measured by amyloid positron emission tomography (PET)","Up to approximately 28 Weeks",{"measure":86,"description":87,"timeFrame":65},"Stage A and C: Maximum Plasma Concentration (Cmax) of ABBV-1758","Cmax of ABBV-1758",{"measure":89,"description":90,"timeFrame":65},"Stage A and C: Time to Cmax (Tmax) of ABBV-1758","Tmax of ABBV-1758",{"measure":92,"description":93,"timeFrame":65},"Stage A and C: Trough Concentration measured at the end of a dosing interval at steady state (Ctrough) of ABBV-1758","Ctrough of ABBV-1758",{"measure":95,"description":96,"timeFrame":65},"Stage A and C: Area under the Plasma Concentration-time Curve from Time Zero to the End of the Dosing Interval (AUCtau) of ABBV-1758","AUCtau of ABBV-1758",{"measure":98,"description":99,"timeFrame":65},"Stage A and C: Average Serum Concentration at Steady-State (Cav,ss) of ABBV-1758","Cav,ss of ABBV-1758",{"measure":101,"description":96,"timeFrame":65},"Stage A and C: Accumulation ratio for (AUCtau) of ABBV-1758",{"measure":103,"description":104,"timeFrame":65},"Stage A and C: Total Body Clearance (CL) of ABBV-1758","CL of ABBV-1758",{"measure":106,"description":107,"timeFrame":65},"Stage A and C: Apparent Clearance (CL\u002FF) of ABBV-1758","CL\u002FF of ABBV-1758",{"measure":109,"description":110,"timeFrame":65},"Stage A and C: Volume of Distribution at Steady-State (Vss)","Vss of ABBV-1758",{"measure":112,"description":113,"timeFrame":65},"Stage A and C: Apparent Volume of Distribution during the Terminal Phase (Vz)","Vz of ABBV-1758",{"measure":115,"description":116,"timeFrame":65},"Stage A and C: Terminal Phase Elimination Rate Constant (β) of ABBV-1758","β of ABBV-1758",{"measure":118,"description":119,"timeFrame":65},"Stage A and C: Terminal Phase Elimination Half-Life (t1\u002F2) of ABBV-1758","Terminal phase elimination half-life of ABBV-1758",{"measure":121,"description":122,"timeFrame":65},"Stage A and C: Effective Half-Life (T1\u002F2,eff)","T1\u002F2,eff of ABBV-1758",[],"ALL","50 Years","90 Years",false,{"inclusion":129,"exclusion":134,"raw_text":144},[130,131,132,133],"Participants meeting all the following criteria for Alzheimer's disease (AD):","In regions where timely testing is feasible (e.g., results available within 4 weeks of Visit 1), plasma biomarker that is predictive of elevated brain amyloid at Screening for participants that do not have known elevated brain amyloid based on previous amyloid positron emission tomography (PET) results.","Participants with amyloid positron emission tomography PET scan results consistent with significant amyloid pathology (as determined by a Centiloid value of 50 or higher).","Participants must have a Mini-Mental State Examination (MMSE) score of 20 or higher at Screening.",[135,136,137,138,139,140,141,142,143],"Participants with screening magnetic resonance imaging (MRI) that show evidence of another potential etiology for progressive dementia.","Participants who have any current serious conditions or illnesses that are not adequately controlled, or any conditions that, in the investigator's opinion, could interfere with the analyses in this study, including but not limited to psychiatric, neurologic (other than AD), cardiovascular, hepatic, renal, gastroenterological, respiratory, endocrinologic, immunologic, or hematologic, metabolic, pulmonary, ophthalmologic, dermatologic, and\u002For any history of abnormal laboratory results that are indicative of significant disease(s).","Participants who had prior exposure to ABBV-1758 or any history of exposure to anti-amyloid beta monoclonal antibody (mAb) treatment.","Participants with other significant pathological findings on brain MRI at screening, including but not limited to:","Evidence of vasogenic edema","4 or more microhemorrhages (defined as 10 mm or less at the greatest diameter)","Any macrohemorrhage (defined as greater than 10 mm at the greatest diameter)","Any superficial siderosis","Severe white matter disease","Inclusion Criteria:\n\n* Participants meeting all the following criteria for Alzheimer's disease (AD):\n\n  * In regions where timely testing is feasible (e.g., results available within 4 weeks of Visit 1), plasma biomarker that is predictive of elevated brain amyloid at Screening for participants that do not have known elevated brain amyloid based on previous amyloid positron emission tomography (PET) results.\n  * Participants with amyloid positron emission tomography PET scan results consistent with significant amyloid pathology (as determined by a Centiloid value of 50 or higher).\n* Participants must have a Mini-Mental State Examination (MMSE) score of 20 or higher at Screening.\n\nExclusion Criteria:\n\n* Participants with screening magnetic resonance imaging (MRI) that show evidence of another potential etiology for progressive dementia.\n* Participants who have any current serious conditions or illnesses that are not adequately controlled, or any conditions that, in the investigator's opinion, could interfere with the analyses in this study, including but not limited to psychiatric, neurologic (other than AD), cardiovascular, hepatic, renal, gastroenterological, respiratory, endocrinologic, immunologic, or hematologic, metabolic, pulmonary, ophthalmologic, dermatologic, and\u002For any history of abnormal laboratory results that are indicative of significant disease(s).\n* Participants who had prior exposure to ABBV-1758 or any history of exposure to anti-amyloid beta monoclonal antibody (mAb) treatment.\n* Participants with other significant pathological findings on brain MRI at screening, including but not limited to:\n\n  * Evidence of vasogenic edema\n  * 4 or more microhemorrhages (defined as 10 mm or less at the greatest diameter)\n  * Any macrohemorrhage (defined as greater than 10 mm at the greatest diameter)\n  * Any superficial siderosis\n  * Severe white matter disease",[146,147],"ADULT","OLDER_ADULT",[149,158,166,179,186,193,200,210,220,228,236],{"facility":150,"status":8,"city":151,"state":152,"zip":153,"country":154,"geoPoint":155},"Irvine Center for Clinical Research \u002FID# 277752","Irvine","California","92614","United States",{"lat":156,"lon":157},33.66946,-117.82311,{"facility":159,"status":8,"city":160,"state":161,"zip":162,"country":154,"geoPoint":163},"Alpine Clinical Research Center - Boulder - 47th Street \u002FID# 277856","Boulder","Colorado","80301",{"lat":164,"lon":165},40.01499,-105.27055,{"facility":167,"status":8,"city":168,"state":169,"zip":170,"country":154,"contacts":171,"geoPoint":176},"Key Clinical Research LLC \u002FID# 277800","Bradenton","Florida","34207",[172],{"name":173,"role":174,"phone":175},"Site Coordinator","CONTACT","941-241-5539",{"lat":177,"lon":178},27.49893,-82.57482,{"facility":180,"status":8,"city":181,"state":169,"zip":182,"country":154,"geoPoint":183},"K2 Medical Research - Clermont \u002FID# 277859","Clermont","34711",{"lat":184,"lon":185},28.54944,-81.77285,{"facility":187,"status":8,"city":188,"state":169,"zip":189,"country":154,"geoPoint":190},"K2 Medical Research - The Villages \u002FID# 278290","Lady Lake","32159",{"lat":191,"lon":192},28.91749,-81.92286,{"facility":194,"status":8,"city":195,"state":169,"zip":196,"country":154,"geoPoint":197},"Alzheimer'S Research And Treatment Center - Stuart \u002FID# 278206","Stuart","34997",{"lat":198,"lon":199},27.19755,-80.25283,{"facility":201,"status":8,"city":202,"state":169,"zip":203,"country":154,"contacts":204,"geoPoint":207},"Alzheimer's Research And Treatment Center - Wellington \u002FID# 277749","Wellington","33414",[205],{"name":173,"role":174,"phone":206},"(561) 209-2400",{"lat":208,"lon":209},26.65868,-80.24144,{"facility":211,"status":8,"city":212,"state":169,"zip":213,"country":154,"contacts":214,"geoPoint":217},"Conquest Research - Winter Park \u002FID# 277760","Winter Park","32789",[215],{"name":173,"role":174,"phone":216},"407-916-0060",{"lat":218,"lon":219},28.6,-81.33924,{"facility":221,"status":8,"city":222,"state":223,"zip":224,"country":154,"geoPoint":225},"Adams Clinical \u002FID# 277754","Watertown","Massachusetts","02472",{"lat":226,"lon":227},42.37093,-71.18283,{"facility":229,"status":8,"city":230,"state":231,"zip":232,"country":154,"geoPoint":233},"Neurology Clinic - Cordova \u002FID# 277790","Cordova","Tennessee","38018",{"lat":234,"lon":235},35.15565,-89.7762,{"facility":237,"status":8,"city":238,"state":239,"zip":240,"country":154,"contacts":241,"geoPoint":244},"Kerwin Medical Center \u002FID# 277788","Dallas","Texas","75231",[242],{"name":173,"role":174,"phone":243},"972-433-9100",{"lat":245,"lon":246},32.78306,-96.80667,[248],{"name":249,"role":174,"phone":250,"email":251},"ABBVIE CALL CENTER","844-663-3742","abbvieclinicaltrials@abbvie.com",[253],{"name":254,"affiliation":13,"role":255},"ABBVIE INC.","STUDY_DIRECTOR",[],[],{"nct_id":4,"conditions":259,"biomarkers":260},[19],[],{"nct_id":4,"found":127,"summary":17,"prompt_version":17}]