Assess Fibrin in Brains With AD/ADRD

• Sponsor: Massachusetts General Hospital (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05336695
• Collaborator: National Heart, Lung, and Blood Institute (NHLBI) (NIH)
• Enrollment: 30
• Location: 1
• Arm: 1
• Anticipated Duration (Months): 6
• Patients Per Site Per Month: 5

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Alzheimer Disease; Dementia of Alzheimer Type	Diagnostic Test: PET/MR Imaging; Drug: 64Cu-FBP8	Phase 1/Phase 2

Detailed Description

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.

The 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).

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 30 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Intervention Model Description: All subjects will receive the same injection of 64Cu-FBP8 and undergo PET/MR imaging.All subjects will receive the same injection of 64Cu-FBP8 and undergo PET/MR imaging.
• Masking: None (Open Label)
• Primary Purpose: Diagnostic
• Official Title: Assess the Brain Levels of Fibrin in Alzheimer's Disease and Its Related Dementias Subjects Using 64Cu-FBP8 PET
• Actual Study Start Date: Mar 29, 2022
• Anticipated Primary Completion Date: Sep 28, 2022
• Anticipated Study Completion Date: Sep 28, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Cognitively Normal Subjects and ADRD subjects Cognitively Normal Subjects and ADRD subjects	Diagnostic Test: PET/MR Imaging; PET/MRI Scan with [64Cu]FBP8 as directed by protocol; Other Names: Positron Emission Tomography/Magnetic Resonance Imaging ; Drug: 64Cu-FBP8; Will be administered by intravenous injection by bolus by a qualified nuclear medicine technician at the Martinos Center; Other Names: Positron Emission Tomography dye

Outcome Measures

Primary Outcome Measures

1. Concentration of fibrin in the brains of ADRD subjects and healthy controls [baseline]

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 55 Years to 90 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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)

• 1. 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Massachusetts General Hospital	Boston	Massachusetts	United States	02115

Sponsors and Collaborators

• Massachusetts General Hospital
• National Heart, Lung, and Blood Institute (NHLBI)

Investigators

• Principal Investigator: Ciprian Catana, MD, PhD, Massachusetts General Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Ciprian Catana, MD, PhD, Principal Investigator, Massachusetts General Hospital
• ClinicalTrials.gov Identifier: NCT05336695
• Other Study ID Numbers: 2019P002911; 3R01HL109448-07S1
• First Posted: Apr 20, 2022
• Last Update Posted: May 2, 2022
• Last Verified: Apr 1, 2022

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: Yes
• Keywords provided by Ciprian Catana, MD, PhD, Principal Investigator, Massachusetts General Hospital: Alzheimer Disease; Dementia
• Additional relevant MeSH terms: Alzheimer Disease; Dementia

Study Results

No Results Posted as of May 2, 2022