Assess Fibrin in Brains With AD/ADRD

Launched by MASSACHUSETTS GENERAL HOSPITAL · Apr 13, 2022

Keywords

ClinConnect Summary

This clinical trial is studying the presence of a substance called fibrin in the brains of people with Alzheimer's disease and related dementias. Researchers want to understand how much fibrin is in different areas of the brain and how this might differ between individuals who are cognitively healthy and those who have been diagnosed with Alzheimer's disease. The trial is currently looking for participants aged 55 to 90 years, including healthy volunteers and those with a clinical diagnosis of Alzheimer's or mild to moderate dementia.

If you decide to join this study, you will undergo a special type of brain scan called a PET scan, which helps measure the amount of fibrin in your brain. To be eligible, you need to be able to give your consent and meet certain health criteria, such as having a specific level of cognitive function. There are also some health conditions and factors that may prevent you from participating, especially related to medical devices or certain health risks. It’s important to know that this study is a first step in research, and your participation could help improve understanding of Alzheimer's disease.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 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 Criteria:
• • 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)
• • 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.