Assess Fibrin in Brains With AD/ADRD
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age55-90
SponsorMassachusetts General Hospital
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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/or MOCA greater than or equal to 12
Disqualifiers
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) < 60 mL/min 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)
Trial design
Design model
Single group
Treatments tested in this trial
PET/MR Imaging
Diagnostic testPET/MRI Scan with \[64Cu\]FBP8 as directed by protocol
64Cu-FBP8
DrugWill be administered by intravenous injection by bolus by a qualified nuclear medicine technician at the Martinos Center
Treatment groups
30 Participants
are divided into 1 treatment groupGroup A: Cognitively Normal Subjects and ADRD subjectsExperimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
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.
Time frame
baselineSponsors and contacts
Click on the lead sponsor to view all of their trials.
Massachusetts General Hospital
Lead sponsor
National Heart, Lung, and Blood Institute (NHLBI)
Collaborator
Source ClinicalTrials.gov