[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT05336695":3,"trial-entities:NCT05336695":97,"trial-summary:NCT05336695":101},{"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":21,"study_type":23,"primary_purpose":24,"phases":25,"enrollment_info":28,"interventions":31,"primary_outcomes":47,"secondary_outcomes":52,"sex":53,"minimum_age":54,"maximum_age":55,"healthy_volunteers":56,"eligibility_criteria":57,"std_ages":71,"locations":74,"central_contacts":91,"overall_officials":93,"references":95,"see_also_links":96},"NCT05336695","2019P002911","Assess Fibrin in Brains With AD\u002FADRD","Assess the Brain Levels of Fibrin in Alzheimer's Disease and Its Related Dementias Subjects Using 64Cu-FBP8 PET","RECRUITING","2026-09-28","2025-10","2025-10-30","2022-03-29","Massachusetts General Hospital","OTHER",false,"The goal of this project is to quantify brain fibrin content using 64Cu-FBP8-PET in the brains of subjects ranging from cognitively normal to clinically diagnosed with ADRD to evaluate potential regional differences.","While there are many potential therapeutics being evaluated for Alzheimer's disease and related dementias (ADRD), there is currently no known cure for ADRD and its origin and pathophysiology are still not well understood. However, the association of fibrin with ADRD is becoming increasingly clearer. Up to now it was not possible to quantify brain fibrin in vivo to better elucidate its role in ADRD, but recently, 64Cu-FBP8 was proposed as a tool to detect thrombus anywhere in the body. This unique tool will allow us to non-invasively assess brain fibrin levels in at-risk and ADRD subjects.\n\nThe goal of this project is to use 64Cu-FBP8-PET in the brains of subjects ranging from cognitively normal to clinically diagnosed with ADRD to assess fibrin levels. It is expected that about 30 people will take part in this research study. 64Cu-FBP8-PET is not currently approved by the U.S. Food and Drug Administration (FDA).",[19,20],"Alzheimer Disease","Dementia of Alzheimer Type",[19,22],"Dementia","INTERVENTIONAL","DIAGNOSTIC",[26,27],"PHASE1","PHASE2",{"count":29,"type":30},30,"ESTIMATED",[32,40],{"type":33,"name":34,"description":35,"armGroupLabels":36,"otherNames":38},"DIAGNOSTIC_TEST","PET\u002FMR Imaging","PET\u002FMRI Scan with \\[64Cu\\]FBP8 as directed by protocol",[37],"Cognitively Normal Subjects and ADRD subjects",[39],"Positron Emission Tomography\u002FMagnetic Resonance Imaging",{"type":41,"name":42,"description":43,"armGroupLabels":44,"otherNames":45},"DRUG","64Cu-FBP8","Will be administered by intravenous injection by bolus by a qualified nuclear medicine technician at the Martinos Center",[37],[46],"Positron Emission Tomography dye",[48],{"measure":49,"description":50,"timeFrame":51},"Concentration of fibrin in the brains of ADRD subjects and healthy controls","64Cu-FBP8-PET will be used to quantify brain fibrin content in the brains of ADRD subjects and healthy controls to evaluate potential regional differences.","baseline",[],"ALL","55 Years","90 Years",true,{"inclusion":58,"exclusion":64,"raw_text":70},[59,60,61,62,63],"Age between 55 and 90 years","Ability to provide informed consent","Specific to healthy volunteers: no history of ADRD","Specific to ADRD subjects: clinical diagnosis of AD - either amnestic or atypical, clinical severity ranging from MCI to moderate dementia (CDR 0.5-2.0), MMSE score greater than or equal to 15 and\u002For MOCA greater than or equal to 12","Specific to BAnD subjects: referred through the Brain Aging and Dementia (BAnD) research registry",[65,66,67,68,69],"MR contraindications such as: electrical implants such as cardiac pacemakers or perfusion pumps; ferromagnetic implants such as aneurysm clips, surgical clips, prostheses, artificial hearts, valves with steel parts, metal fragments, shrapnel, tattoos near the eye, or steel implants, ferromagnetic objects such as jewelry or metal clips in clothing","Preexisting medical conditions including a likelihood of developing seizures or claustrophobic reactions, and any greater than normal potential for cardiac arrest","Subjects whose estimated glomerular filtration rate (eGFR) \\\u003C 60 mL\u002Fmin will be excluded from receiving the gadolinium-based contrast agent","Research-related radiation exposure exceeding current Massachusetts General Hospital (MGH) Radiology Department guidelines (i.e. 50 millisievert in the prior 12 months)","3\\. In line with published MGH IRB guidelines for pregnancy must be ruled out by urine ß-HCG if answers to screening questions suggest that pregnancy is possible and if female participants are premenopausal and of child-bearing age. Subjects will not be able to enroll if they are breastfeeding.","Inclusion Criteria:\n\n* Age between 55 and 90 years\n* Ability to provide informed consent\n* Specific to healthy volunteers: no history of ADRD\n* Specific to ADRD subjects: clinical diagnosis of AD - either amnestic or atypical, clinical severity ranging from MCI to moderate dementia (CDR 0.5-2.0), MMSE score greater than or equal to 15 and\u002For MOCA greater than or equal to 12\n* Specific to BAnD subjects: referred through the Brain Aging and Dementia (BAnD) research registry\n\nExclusion Criteria:\n\n* MR contraindications such as: electrical implants such as cardiac pacemakers or perfusion pumps; ferromagnetic implants such as aneurysm clips, surgical clips, prostheses, artificial hearts, valves with steel parts, metal fragments, shrapnel, tattoos near the eye, or steel implants, ferromagnetic objects such as jewelry or metal clips in clothing\n* Preexisting medical conditions including a likelihood of developing seizures or claustrophobic reactions, and any greater than normal potential for cardiac arrest\n* Subjects whose estimated glomerular filtration rate (eGFR) \\\u003C 60 mL\u002Fmin will be excluded from receiving the gadolinium-based contrast agent\n* Research-related radiation exposure exceeding current Massachusetts General Hospital (MGH) Radiology Department guidelines (i.e. 50 millisievert in the prior 12 months)\n* 3\\. In line with published MGH IRB guidelines for pregnancy must be ruled out by urine ß-HCG if answers to screening questions suggest that pregnancy is possible and if female participants are premenopausal and of child-bearing age. Subjects will not be able to enroll if they are breastfeeding.",[72,73],"ADULT","OLDER_ADULT",[75],{"facility":13,"status":8,"city":76,"state":77,"zip":78,"country":79,"contacts":80,"geoPoint":88},"Boston","Massachusetts","02115","United States",[81,86],{"name":82,"role":83,"phone":84,"email":85},"Ciprian Catana, MD, PhD","CONTACT","617-643-4885","ccatana@mgh.harvard.edu",{"name":82,"role":87},"PRINCIPAL_INVESTIGATOR",{"lat":89,"lon":90},42.35843,-71.05977,[92],{"name":82,"role":83,"phone":84,"email":85},[94],{"name":82,"affiliation":13,"role":87},[],[],{"nct_id":4,"conditions":98,"biomarkers":100},[99,22],"Alzheimer's Disease",[],{"nct_id":4,"found":56,"summary":102,"prompt_version":112},{"design":103,"status":104,"heading":105,"summary":106,"follow_up":107,"word_count":108,"commitments":109,"compensation":110,"drugs_mentioned":111},"This is an interventional study, meaning participants will receive an intervention (64Cu-FBP8 and PET\u002FMR imaging). Approximately 30 people are planned to enroll.","completed","Assessing Fibrin in Brains with Alzheimer's Disease and Related Dementias","This study is looking at how much fibrin (a protein involved in blood clotting) is in the brains of people with Alzheimer's disease and related dementias (ADRD) compared to healthy individuals. Researchers will use a special imaging technique called PET\u002FMR Imaging with a substance called 64Cu-FBP8. This substance is given through an IV and helps them see fibrin in the brain. The goal is to understand if fibrin plays a role in ADRD by measuring its concentration in the brain. About 30 people between 55 and 90 years old can participate. This includes healthy volunteers and those with a clinical diagnosis of AD, ranging from mild cognitive impairment (MCI) to moderate dementia.","The primary endpoint, concentration of fibrin, is measured at baseline, meaning at the start of the study.",112,"Participants will undergo a PET\u002FMRI scan with 64Cu-FBP8, which will be administered intravenously by a qualified nuclear medicine technician.","Not stated in the trial record.",[34,42],"v2"]