NCT05336695 Assess Fibrin in Brains With AD/ADRD
| NCT ID | NCT05336695 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | Massachusetts General Hospital |
| Condition | Alzheimer Disease |
| Study Type | INTERVENTIONAL |
| Enrollment | 30 participants |
| Start Date | 2022-03-29 |
| Primary Completion | 2026-09-28 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 30 participants in total. It began in 2022-03-29 with a primary completion date of 2026-09-28.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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.
Contact & Investigator
Ciprian Catana, MD, PhD
PRINCIPAL INVESTIGATOR
Massachusetts General Hospital
Frequently Asked Questions
Who can join the NCT05336695 clinical trial?
This trial is open to participants of all sexes, aged 55 Years or older, up to 90 Years, studying Alzheimer Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05336695 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT05336695 currently recruiting?
Yes, NCT05336695 is actively recruiting participants. Contact the research team at ccatana@mgh.harvard.edu for enrollment information.
Where is the NCT05336695 trial being conducted?
This trial is being conducted at Boston, United States.
Who is sponsoring the NCT05336695 clinical trial?
NCT05336695 is sponsored by Massachusetts General Hospital. The principal investigator is Ciprian Catana, MD, PhD at Massachusetts General Hospital. The trial plans to enroll 30 participants.
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