What side effects are associated with this type of intervention?

The most common treatments for Alzheimer's Disease include cholinesterase inhibitors (such as donepezil, rivastigmine, and galantamine) and memantine. Cholinesterase inhibitors can cause side effects like gastrointestinal issues (nausea, vomiting, diarrhea), muscle cramps, and insomnia. Memantine, used for moderate to severe AD, may lead to dizziness, headache, confusion, and constipation. Treatments targeting amyloid plaques, such as aducanumab, have been associated with amyloid-related imaging abnormalities (ARIA), including brain swelling and microhemorrhages, as well as headaches, falls, and hypersensitivity reactions.

What prior FDA approvals exist?

Aducanumab is a notable FDA-approved treatment for Alzheimer's Disease that targets amyloid plaques in the brain, which are detected using imaging techniques like PiB PET. This drug is administered via intravenous infusion and requires regular brain MRI monitoring due to potential side effects such as amyloid-related imaging abnormalities (ARIA). Other treatments for Alzheimer's Disease include cholinesterase inhibitors like donepezil and memantine, which are used to manage symptoms but do not directly target amyloid plaques.

What other types of research exist?

Promising alternatives to PiB PET imaging for detecting amyloid plaques in Alzheimer's Disease patients include: 1) Florbetapir (18F) PET, which has been FDA-approved and is widely used for amyloid imaging. 2) Florbetaben (18F) PET, another FDA-approved tracer that binds to amyloid plaques. 3) Flutemetamol (18F) PET, also FDA-approved, providing high sensitivity and specificity for amyloid detection. These alternatives offer similar diagnostic capabilities and are expected to be accessible for clinical use in 2024.

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Brain Amyloid Imaging for Alzheimer's Disease

Phase 4

Waitlist Available

Led By Val Lowe, M.D.

Research Sponsored by Mayo Clinic

Eligibility Criteria Checklist

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

Must have

Age 30-100

Be older than 18 years old

Must not have

Subjects unable to lie down without moving for 10 minutes

Women who are pregnant or cannot stop breast feeding for 24 hours

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

Pivotal Trial

Drug Has Already Been Approved

No Placebo-Only Group

Summary

This trial uses a special brain scan to see harmful buildups in the brain. It targets both healthy people and those with brain diseases to understand how well the scan works.

Who is the study for?

This trial is for people aged 30-100 with various forms of dementia, including Alzheimer's and Lewy Body Disease, who are part of the Mayo Clinic aging or neurodegenerative studies. It excludes pregnant or breastfeeding women, those unable to lie still for scans, claustrophobic individuals, and anyone with MRI safety risks like pacemakers.

What is being tested?

The study tests imaging agents (Pittsburgh Compound B, F-18 FDG, Tau) using PET scans to track amyloid plaque buildup in the brain over time and its link to changes in clinical status among aging individuals.

What are the potential side effects?

As this is a diagnostic imaging study focusing on brain scanning techniques rather than medication or therapy trials, it does not list specific side effects related to treatments.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 30 and 100 years old.

Exclusion Criteria

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

Select...

I cannot stay still lying down for 10 minutes.

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I am not pregnant and can stop breastfeeding for 24 hours.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Awards & Highlights

Pivotal Trial

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

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.

Trial Design

1Treatment groups

Experimental Treatment

Group I: PiB PET, FDG PET, Tau PETExperimental Treatment3 Interventions

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

F-18 FDG

2010

Completed Phase 2

~270

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

The most common treatments for Alzheimer's Disease (AD) include cholinesterase inhibitors (donepezil, rivastigmine, galantamine) and NMDA receptor antagonists (memantine). Cholinesterase inhibitors work by preventing the breakdown of acetylcholine, a neurotransmitter important for learning and memory, thereby enhancing cholinergic function. Memantine, on the other hand, regulates glutamate activity to prevent excitotoxicity, which can damage neurons. Additionally, treatments targeting amyloid plaques, such as those studied in PiB PET Imaging trials, aim to reduce amyloid-beta accumulation, which is believed to play a critical role in AD pathogenesis by forming plaques that disrupt cell function. These mechanisms are crucial as they address the underlying biochemical pathways involved in AD, potentially slowing disease progression and improving cognitive function.