What side effects are associated with this type of intervention?

Common treatments for Alzheimer's Disease, such as aducanumab, vitamin E, and hormone replacement therapy (HRT), have various side effects. Aducanumab can cause amyloid-related imaging abnormalities (ARIA), headaches, falls, diarrhea, and confusion. Vitamin E is generally well-tolerated but may offer only modest benefits. HRT has been associated with an increased risk of developing dementia in older women and does not improve cognitive or functional outcomes in Alzheimer's patients. These treatments, particularly those targeting amyloid plaques and tau protein aggregates, require careful consideration of their potential risks and benefits.

What prior FDA approvals exist?

The FDA has approved several treatments for Alzheimer's Disease that target amyloid plaques, including aducanumab, which is a monoclonal antibody that reduces amyloid-beta plaques in the brain. Other drugs in clinical trials, such as solanezumab, aducanumab, crenezumab, and gantenerumab, also target various forms of amyloid-beta. While there are no FDA-approved treatments specifically targeting tau proteins, ongoing research and trials, like those involving [18F]APN-1607 for PET imaging, aim to better understand and develop treatments for tau-related pathology in Alzheimer's Disease.

What other types of research exist?

Promising alternatives to [18F]APN-1607 for PET imaging in Alzheimer's Disease patients include [18F]Flortaucipir (also known as [18F]AV-1451), which binds to tau protein aggregates, and [18F]Florbetapir, which targets amyloid plaques. Both have shown efficacy in detecting AD-related pathology and are widely used in clinical settings.

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[18F]APN-1607 PET Imaging for Alzheimer's Disease

Phase 2

Waitlist Available

Led By David Russell, M.D., Ph.D

Research Sponsored by APRINOIA Therapeutics, LLC

Eligibility Criteria Checklist

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

Must have

Males or females aged 50 to 85 years, inclusive.

No first-degree family history of early-onset AD or other neurodegenerative disease associated with dementia (prior to age 65).

Timeline

Screening 3 weeks

Treatment Varies

Follow Up day 7

Awards & highlights

No Placebo-Only Group

Summary

This trial uses a special imaging agent to study brain patterns in people with mild dementia, Alzheimer's disease, and healthy individuals. The agent helps highlight abnormal brain proteins. A similar imaging agent was recently approved for visualizing amyloid.

Who is the study for?

This trial is for men and women aged 50-85, who are either not able to have children or agree to use contraception. It's for those with mild to moderate Alzheimer's Disease (MDAD), AD dementia, or healthy without cognitive impairment. Participants must be in good physical health with no relevant medical issues.

What is being tested?

[18F]APN-1607 uptake patterns are being compared across individuals with MDAD, AD dementia, and healthy subjects. The goal is to see how this imaging agent behaves differently among these groups which could help in understanding and diagnosing Alzheimer's Disease.

What are the potential side effects?

The side effects of [18F]APN-1607 aren't detailed here but typically PET scan tracers can cause reactions at the injection site, a metallic taste in the mouth or a brief feeling of coldness from the injection.

Eligibility Criteria

Inclusion Criteria

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

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I am between 50 and 85 years old.

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My immediate family has no history of early-onset Alzheimer's or similar diseases before 65.

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I am in good health with no significant issues found in my recent medical checks.

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I will not donate sperm during the study.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ day 7

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~day 7

This trial's timeline: 3 weeks for screening, Varies for treatment, and day 7 for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Assessment of [18F]APN-1607 Uptake Patterns by Regional SUVR Values

Secondary study objectives

Number of Adverse Events (AEs)

Number of Serious Adverse Events (SAEs)

Number of participants with ECG abnormalities

+2 more

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: [18F]APN-1607Experimental Treatment1 Intervention

Subjects will undergo PET imaging using \[18F\]APN-1607.

0 / 4Eligibility 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 include cholinesterase inhibitors (donepezil, rivastigmine, galantamine) and the NMDA receptor antagonist memantine. Cholinesterase inhibitors work by increasing acetylcholine levels in the brain, which helps improve cognitive function and memory. Memantine helps regulate glutamate activity to prevent excitotoxicity, which can damage neurons. Recent research, including the [18F]APN-1607 trial, focuses on tau protein aggregates, a hallmark of AD pathology. These treatments and research efforts are crucial as they target the underlying mechanisms of AD, aiming to slow disease progression and improve patient outcomes.