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Assess Fibrin in Brains With AD/ADRD

Primary Purpose

Alzheimer Disease, Dementia of Alzheimer Type

Status

Recruiting

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

PET/MR Imaging

64Cu-FBP8

About this trial

This is an interventional diagnostic trial for Alzheimer Disease focused on measuring Alzheimer Disease, Dementia

Eligibility Criteria

55 Years - 90 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

Massachusetts General HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Cognitively Normal Subjects and ADRD subjects

Arm Description

Cognitively Normal Subjects and ADRD subjects

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

NCT ID

NCT05336695

First Posted

April 6, 2022

Last Updated

February 7, 2023

Sponsor

Massachusetts General Hospital

Collaborators

National Heart, Lung, and Blood Institute (NHLBI)

1. Study Identification

Unique Protocol Identification Number

NCT05336695

Brief Title

Assess Fibrin in Brains With AD/ADRD

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2023

Overall Recruitment Status

Recruiting

Study Start Date

March 29, 2022 (Actual)

Primary Completion Date

September 28, 2024 (Anticipated)

Study Completion Date

September 28, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Massachusetts General Hospital

Collaborators

National Heart, Lung, and Blood Institute (NHLBI)

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Yes

Data Monitoring Committee

5. 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.

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Alzheimer Disease, Dementia of Alzheimer Type

Keywords

Alzheimer Disease, Dementia

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Phase 1, Phase 2

Interventional Study Model

Single Group Assignment

Model Description

All subjects will receive the same injection of 64Cu-FBP8 and undergo PET/MR imaging.

Masking

None (Open Label)

Allocation

N/A

Enrollment

30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Cognitively Normal Subjects and ADRD subjects

Arm Type

Experimental

Arm Description

Cognitively Normal Subjects and ADRD subjects

Intervention Type

Diagnostic Test

Intervention Name(s)

PET/MR Imaging

Other Intervention Name(s)

Positron Emission Tomography/Magnetic Resonance Imaging

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

64Cu-FBP8

Other Intervention Name(s)

Positron Emission Tomography dye

Intervention Description

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

Primary Outcome Measure Information:

Title

Concentration of fibrin in the brains of ADRD subjects and healthy controls

Description

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

baseline

10. Eligibility

Sex

All

Minimum Age & Unit of Time

55 Years

Maximum Age & Unit of Time

90 Years

Accepts Healthy Volunteers

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Ciprian Catana, MD, PhD

Phone

617-643-4885

ccatana@mgh.harvard.edu

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Ciprian Catana, MD, PhD

Organizational Affiliation

Massachusetts General Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Massachusetts General Hospital

City

Boston

State/Province

Massachusetts

ZIP/Postal Code

02115

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Ciprian Catana, MD, PhD

Phone

617-643-4885

ccatana@mgh.harvard.edu

First Name & Middle Initial & Last Name & Degree

Ciprian Catana, MD, PhD

12. IPD Sharing Statement

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Assess Fibrin in Brains With AD/ADRD

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