RecruitingPhase 1Phase 2NCT05336695

Assess Fibrin in Brains With AD/ADRD

Assess the Brain Levels of Fibrin in Alzheimer's Disease and Its Related Dementias Subjects Using 64Cu-FBP8 PET


Sponsor

Massachusetts General Hospital

Enrollment

30 participants

Start Date

Mar 29, 2022

Study Type

INTERVENTIONAL

Conditions

Summary

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

Min Age: 55 YearsMax Age: 90 Years

Inclusion Criteria5

  • 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
  • Specific to BAnD subjects: referred through the Brain Aging and Dementia (BAnD) research registry

Exclusion Criteria5

  • 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)
  • \. 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.

Interventions

DIAGNOSTIC_TESTPET/MR Imaging

PET/MRI Scan with \[64Cu\]FBP8 as directed by protocol

DRUG64Cu-FBP8

Will be administered by intravenous injection by bolus by a qualified nuclear medicine technician at the Martinos Center


Locations(1)

Massachusetts General Hospital

Boston, Massachusetts, United States

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT05336695


Related Trials