Alzheimer DiseasePhase 1/2NCT05336695
Assess Fibrin in Brains With AD/ADRD
A Phase 1/2 study testing PET/MR Imaging and 64Cu-FBP8 in people with Alzheimer Disease and Dementia of Alzheimer Type, run by Massachusetts General Hospital at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 55 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Alzheimer Disease, Dementia of Alzheimer Type
- What is being tested?
- PET/MR Imaging and 64Cu-FBP8
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Mar 2022to 28 Sep 2026
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Massachusetts General Hospital
Boston, Massachusetts, 02115
Ciprian Catana, MD, PhD, 617-643-4885, ccatana@mgh.harvard.edu
Ciprian Catana, MD, PhD
About this study
Official title: Assess the Brain Levels of Fibrin in Alzheimer's Disease and Its Related Dementias Subjects Using 64Cu-FBP8 PET
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.
Read the 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).
- Conditions
- Alzheimer Disease, Dementia of Alzheimer Type
- Being tested
- PET/MR Imaging, 64Cu-FBP8
- Keywords
- Alzheimer Disease, Dementia
- Medical subject headings
- Alzheimer Disease, Dementia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PET/MR ImagingDiagnostic test
Also called Positron Emission Tomography/Magnetic Resonance Imaging
PET/MRI Scan with [64Cu]FBP8 as directed by protocol
64Cu-FBP8Drug
Also called Positron Emission Tomography dye
Will be administered by intravenous injection by bolus by a qualified nuclear medicine technician at the Martinos Center
| Study group | Role | What they receive |
|---|---|---|
| Cognitively Normal Subjects and ADRD subjects | Experimental | Cognitively Normal Subjects and ADRD subjects Receives: Diagnostic Test: PET/MR Imaging; Drug: 64Cu-FBP8 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2022
- Study start29 Mar 2022
- Primary completion28 Sep 2026 (estimated)
- Study completion28 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alzheimer DiseaseStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- All subjects will receive the same injection of 64Cu-FBP8 and undergo PET/MR imaging.
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Principal investigator, Ciprian Catana, MD, PhD, Massachusetts General Hospital
- Investigators
- Ciprian Catana, MD, PhD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05336695
- Sponsor's protocol ID
- 2019P002911
- Other IDs
- 3R01HL109448-07S1
- Status last verified
- Oct 2025
- First submitted
- 6 Apr 2022
- Last updated
- 30 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assess the Brain Levels of Fibrin in Alzheimer's Disease and Its Related Dementias Subjects Using 64Cu-FBP8 PET
- ClinicalTrials.gov ID
- NCT05336695
- Acronym / sponsor ID
- 2019P002911
- Conditions
- Alzheimer Disease, Dementia of Alzheimer Type
- Keywords
- Alzheimer Disease, Dementia
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- 29 Mar 2022 (actual)
- Primary completion
- 28 Sep 2026 (estimated)
- Study completion
- 28 Sep 2026 (estimated)
- First posted
- 20 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- All subjects will receive the same injection of 64Cu-FBP8 and undergo PET/MR imaging.
| Arm | Type | Receives |
|---|---|---|
| Cognitively Normal Subjects and ADRD subjects | Experimental | Diagnostic Test: PET/MR Imaging, Drug: 64Cu-FBP8Cognitively Normal Subjects and ADRD subjects |
Who may qualify
- Ages
- 55 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PET/MR ImagingAlso: Positron Emission Tomography/Magnetic Resonance ImagingPET/MRI Scan with [64Cu]FBP8 as directed by protocol | Diagnostic test | Cognitively Normal Subjects and ADRD subjects |
| 64Cu-FBP8Also: Positron Emission Tomography dyeWill be administered by intravenous injection by bolus by a qualified nuclear medicine technician at the Martinos Center | Drug | Cognitively Normal Subjects and ADRD subjects |
Primary outcome
Concentration of fibrin in the brains of ADRD subjects and healthy controls
Time frame: 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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ciprian Catana, MD, PhD principal investigator
Massachusetts General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing PET/MR Imaging and 64Cu-FBP8 in people with Alzheimer Disease and Dementia of Alzheimer Type, run by Massachusetts General Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 30 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ciprian Catana, MD, PhD (617-643-4885, ccatana@mgh.harvard.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Concentration of fibrin in the brains of ADRD subjects and healthy controls (time frame: baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Oct 2025.