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Radiopharmaceutical

64Cu-FBP8 PET Scan for Alzheimer's Disease

Phase 1 & 2
Recruiting
Led By Ciprian Catana, MD, PhD
Research Sponsored by Massachusetts General Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age between 55 and 90 years
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline
Awards & highlights

Study Summary

This trialtests if brain fibrin levels can detect Alzheimer's and other dementias, by measuring it with a PET scan.

Who is the study for?
This trial is for adults aged 55-90 with Alzheimer's Disease or dementia, who can consent to participate. Healthy volunteers must have no history of these conditions. Participants should not have metal implants, be at risk for seizures or claustrophobia, and must not exceed radiation exposure limits.Check my eligibility
What is being tested?
The study uses a special PET/MR imaging technique with a tracer called 64Cu-FBP8 to measure the amount of fibrin in the brain, which could help understand differences in brain regions affected by Alzheimer's Disease and related dementias.See study design
What are the potential side effects?
Potential side effects may include reactions to the contrast agent used during imaging if kidney function is normal (eGFR ≥60 mL/min). There might also be risks associated with exposure to radiation from the PET scan.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 55 and 90 years old.
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I have Alzheimer's with mild to moderate symptoms and my mental test scores are above the minimum.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Concentration of fibrin in the brains of ADRD subjects and healthy controls

Trial Design

1Treatment groups
Experimental Treatment
Group I: Cognitively Normal Subjects and ADRD subjectsExperimental Treatment2 Interventions
Cognitively Normal Subjects and ADRD subjects

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

Massachusetts General HospitalLead Sponsor
2,934 Previous Clinical Trials
13,198,551 Total Patients Enrolled
National Heart, Lung, and Blood Institute (NHLBI)NIH
3,838 Previous Clinical Trials
47,851,624 Total Patients Enrolled
Ciprian Catana, MD, PhDPrincipal InvestigatorMassachusetts General Hospital

Media Library

64Cu-FBP8 (Radiopharmaceutical) Clinical Trial Eligibility Overview. Trial Name: NCT05336695 — Phase 1 & 2
Alzheimer's Disease Research Study Groups: Cognitively Normal Subjects and ADRD subjects
Alzheimer's Disease Clinical Trial 2023: 64Cu-FBP8 Highlights & Side Effects. Trial Name: NCT05336695 — Phase 1 & 2
64Cu-FBP8 (Radiopharmaceutical) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05336695 — Phase 1 & 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Assess Fibrin in Brains With AD/ADRD
Ciprian Catana, MD, PhD 2022. "Assess Fibrin in Brains With AD/ADRD". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05336695.
All > Alzheimers Disease Boston
~5 spots leftby Sep 2024
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