RECRUITING

Assess Fibrin in Brains With AD/ADRD

Conditions

Alzheimer Disease Dementia of Alzheimer Type Dementia

Quick Navigation

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2022-03-29

Study Completion:2025-09-28

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05336695

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:55 Years to 90 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:Yes

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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	* 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.

Inclusion Criteria

Exclusion 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

* 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.

Contacts and Locations

Study Contact

Ciprian Catana, MD, PhD

CONTACT

617-643-4885

ccatana@mgh.harvard.edu

Principal Investigator

Ciprian Catana, MD, PhD

PRINCIPAL_INVESTIGATOR

Massachusetts General Hospital

Study Locations (Sites)

Massachusetts General Hospital

Boston, Massachusetts, 02115

United States

Collaborators and Investigators

Sponsor: Massachusetts General Hospital

Ciprian Catana, MD, PhD, PRINCIPAL_INVESTIGATOR, Massachusetts General Hospital

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-03-29

Study Completion Date2025-09-28

Study Record Updates

Study Start Date2022-03-29

Study Completion Date2025-09-28

Terms related to this study

Keywords Provided by Researchers

Alzheimer Disease
Dementia

Additional Relevant MeSH Terms

Alzheimer Disease
Dementia of Alzheimer Type