What side effects are associated with this type of intervention?

Common treatments for dementia, such as cholinergic treatments (e.g., physostigmine), amyloid-targeting therapies (e.g., donanemab), and cognition enhancers (e.g., piracetam, acetyl-L-carnitine, nimodipine), have various side effects. Cholinergic treatments may cause systemic adverse effects requiring dose adjustments. Amyloid-targeting therapies like donanemab can lead to amyloid-related imaging abnormalities (ARIA), headaches, falls, diarrhea, and confusion. Cognition enhancers can have side effects influenced by the severity of the disease, but generally, they are well-tolerated. Overall, while these treatments can offer benefits, they also come with potential risks that need to be managed under medical supervision.

What prior FDA approvals exist?

The FDA has approved several drugs for the treatment of dementia, particularly Alzheimer's disease. These include cholinesterase inhibitors like donepezil, rivastigmine, and galantamine, which work by increasing levels of acetylcholine in the brain. Another class of drugs includes NMDA receptor antagonists like memantine, which help regulate glutamate activity. While 123I-MIBG is a radioactive imaging agent used for myocardial scintigraphy and not directly a treatment, it highlights the importance of advanced imaging techniques in diagnosing and monitoring neurological conditions. These imaging agents can complement pharmacological treatments by providing detailed insights into disease progression and treatment efficacy.

What other types of research exist?

Promising, novel alternatives to 123I-MIBG for dementia patients include PET tracers such as 18F-fluorodeoxyglucose (FDG), which measures glucose metabolism, and newer agents targeting amyloid plaques (e.g., 18F-florbetapir) or tau proteins (e.g., 18F-flortaucipir). These imaging agents provide detailed insights into the pathological processes of dementia and are increasingly used in clinical practice.

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MIBG Scanning for Lewy Body Disease

Phase 4

Waitlist Available

Led By Bradley Boeve, MD

Research Sponsored by Mayo Clinic

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Must not have

Women who are pregnant or are breast-feeding an infant

Myocardial infarction or cerebral infarct over preceding year, stable or unstable angina, known symptomatic coronary artery disease

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 10 years

Awards & highlights

Drug Has Already Been Approved

No Placebo-Only Group

Pivotal Trial

Summary

This trial uses a special radioactive drug and a heart scan to help identify Lewy Body Disease in people with certain neurological symptoms. The scan checks how well the heart absorbs the drug to find early signs of this brain disorder.

Who is the study for?

This trial is for individuals with certain neurological disorders like Lewy Body Disease, Parkinson's, or dementia. Participants need a caregiver present at least 20 hours per week and must have stable medication use without severe medical conditions that could interfere with the study.

What is being tested?

The trial tests a radioactive drug called 123I-MIBG and its ability to diagnose Lewy Body Disease through myocardial MIBG scintigraphy scans. It aims to improve disease prediction by correlating scan results with other clinical data.

What are the potential side effects?

Potential side effects may include reactions related to the radioactivity of the drug (such as nausea), sensitivity to iodine in the compound, or issues due to pre-existing kidney problems.

Eligibility Criteria

Exclusion Criteria

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

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I am currently pregnant or breastfeeding.

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I have had a heart attack or stroke in the last year, or I have ongoing heart problems.

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I am willing and able to follow all study-related procedures.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 10 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~10 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 10 years for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Correlate myocardial 123I-MIBG scintigraphy findings

Awards & Highlights

Drug Has Already Been Approved

The FDA has already approved this drug, and is just seeking more data.

No Placebo-Only Group

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

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Myocardial 123I-MIBG scintigraphy imagingExperimental Treatment2 Interventions

Subjects with with normal neurologic functioning, REM sleep without atonia, RBD, parkinsonism, cognitive impairment, or some combination of these will undergo myocardial 123I-MIBG scintigraphy imaging

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 dementia, particularly Alzheimer's disease, often involve cholinesterase inhibitors like rivastigmine, which increase acetylcholine levels in the brain to improve memory and cognitive function. Additionally, imaging agents such as 123I-MIBG are used to monitor brain activity and receptor function, aiding in the assessment of disease progression and treatment efficacy. These approaches are crucial for personalizing treatment plans and ensuring that patients receive the most effective care.

Effects of cholinergic enhancement therapies on memory function in Alzheimer's disease: a meta-analysis of the literature.Muscarinic acetylcholine receptors in Alzheimer's disease. In vivo imaging with iodine 123-labeled 3-quinuclidinyl-4-iodobenzilate and emission tomography.Transcranial photobiomodulation (laser) therapy for cognitive impairment: A review of molecular mechanisms and potential application to canine cognitive dysfunction (CCD).