What side effects are associated with this type of intervention?

Common treatments for Alzheimer's Disease, such as cholinesterase inhibitors (donepezil, rivastigmine, galantamine) and NMDA receptor antagonists (memantine), often have side effects including nausea, vomiting, diarrhea, dizziness, headache, and confusion. Imaging agents used in PET scans, like 64Cu-FBP8-PET, generally have fewer side effects but can include mild reactions at the injection site, allergic reactions, and rare instances of radiation exposure-related issues. It is important to discuss these potential side effects with a healthcare provider to manage and mitigate risks effectively.

What prior FDA approvals exist?

The FDA has approved several treatments for Alzheimer's Disease, primarily focusing on targeting amyloid plaques and neurotransmitter modulation. Aducanumab, approved in 2021, is a monoclonal antibody that reduces amyloid plaques in the brain. Other treatments include cholinesterase inhibitors like donepezil, rivastigmine, and galantamine, which help increase levels of acetylcholine in the brain, and memantine, an NMDA receptor antagonist that regulates glutamate activity. While these treatments address different aspects of Alzheimer's pathology, there are no FDA-approved imaging agents specifically targeting fibrin for PET imaging in Alzheimer's Disease.

What other types of research exist?

Promising alternatives to 64Cu-FBP8-PET for Alzheimer's Disease patients include amyloid PET imaging agents such as Florbetapir (18F), Flutemetamol (18F), and Florbetaben (18F), which are used to detect amyloid plaques. Tau PET imaging agents like Flortaucipir (18F) are also promising as they target tau protein tangles. Additionally, advancements in MRI techniques, such as high-resolution structural MRI and functional MRI (fMRI), as well as the use of blood-based biomarkers, are emerging as non-invasive diagnostic tools for AD.

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Radiopharmaceutical

64Cu-FBP8 PET Scan for Alzheimer's Disease

Q: What is the mechanism of action of this treatment?

Common treatments for Alzheimer's Disease (AD) primarily target amyloid plaques and neurotransmitter imbalances. Aducanumab, for example, is a monoclonal antibody that reduces amyloid-beta plaques in the brain, potentially slowing disease progression. Cholinesterase inhibitors (e.g., donepezil, rivastigmine) increase acetylcholine levels, improving communication between nerve cells. NMDA receptor antagonists like memantine regulate glutamate activity to prevent excitotoxicity. Imaging agents like 64Cu-FBP8-PET, although not a treatment, help visualize fibrin deposits, aiding in the diagnosis and monitoring of AD. These mechanisms are crucial as they address different aspects of AD pathology, offering a multi-faceted approach to managing the 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

Must not have

Subjects with estimated glomerular filtration rate (eGFR) < 60 mL/min will be excluded from receiving the gadolinium-based contrast agent

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline

Awards & highlights

No Placebo-Only Group

Summary

This trial uses a special brain scan to detect certain protein levels in people ranging from normal cognitive function to those with Alzheimer's disease and related dementias. The scan helps researchers understand how these proteins are distributed in the brain.

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.

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.

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

Select...

I am between 55 and 90 years old.

Select...

I have Alzheimer's with mild to moderate symptoms and my mental test scores are above the minimum.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

My kidney function is good enough for a specific MRI contrast.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Cognitively Normal Subjects and ADRD subjectsExperimental Treatment2 Interventions

Cognitively Normal Subjects and ADRD subjects

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

PET/MR Imaging

2021

N/A

~30

0 / 3Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for Alzheimer's Disease (AD) primarily target amyloid plaques and neurotransmitter imbalances. Aducanumab, for example, is a monoclonal antibody that reduces amyloid-beta plaques in the brain, potentially slowing disease progression. Cholinesterase inhibitors (e.g., donepezil, rivastigmine) increase acetylcholine levels, improving communication between nerve cells. NMDA receptor antagonists like memantine regulate glutamate activity to prevent excitotoxicity. Imaging agents like 64Cu-FBP8-PET, although not a treatment, help visualize fibrin deposits, aiding in the diagnosis and monitoring of AD. These mechanisms are crucial as they address different aspects of AD pathology, offering a multi-faceted approach to managing the disease.

scyllo-Inositol, preclinical, and clinical data for Alzheimer's disease.