What is the mechanism of action of this treatment?

The most common treatments for Alzheimer's Disease (AD) include cholinesterase inhibitors and tau PET radiopharmaceuticals. Cholinesterase inhibitors, such as donepezil, rivastigmine, and galantamine, increase cholinergic transmission by inhibiting the enzyme cholinesterase, leading to modest improvements in cognition and global functioning. Tau PET radiopharmaceuticals like Flortaucipir and MK-6240 are used to measure tau tangles, a key feature of AD pathology, aiding in diagnosis and monitoring disease progression. These treatments are important as they help manage symptoms and track the effectiveness of therapeutic interventions in AD patients.

What side effects are associated with this type of intervention?

Common treatments for Alzheimer's Disease include cholinesterase inhibitors (such as donepezil, rivastigmine, and galantamine) and NMDA receptor antagonists (such as memantine). Known side effects of these treatments can include nausea, vomiting, diarrhea, muscle cramps, fatigue, and insomnia. For treatments similar to Flortaucipir and MK-6240, which are Tau PET radiopharmaceuticals used for imaging rather than direct treatment, specific side effects are not detailed in the provided context. However, general side effects of radiopharmaceuticals can include allergic reactions, injection site reactions, and radiation exposure-related risks.

What prior FDA approvals exist?

The FDA has approved several treatments for Alzheimer's Disease, primarily targeting amyloid plaques and neurotransmitter systems. Notably, aducanumab (Aduhelm) is an amyloid-beta-directed antibody approved for reducing amyloid plaques. While tau-targeting treatments like Flortaucipir and MK-6240 are still under investigation, they represent a promising approach by focusing on tau tangles, another hallmark of Alzheimer's pathology. These tau PET radiopharmaceuticals are used for imaging and measuring tau tangles, aiding in diagnosis and monitoring disease progression.

What other types of research exist?

Promising novel alternatives to Flortaucipir and MK-6240 for measuring tau tangles in Alzheimer's Disease include THK-5351 and PI-2620. These agents have shown potential in recent studies for their ability to effectively image tau pathology.

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Radiopharmaceutical

Tau Tracer Comparison for Alzheimer's Disease (HEAD Trial)

Phase 1

Recruiting

Led By Tharick Pascoal, MD, PhD

Research Sponsored by Tharick Pascoal

Eligibility Criteria Checklist

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

Must have

Willing and capable of undergoing repeated MR/PET imaging.

Fluent in a language approved by the coordinating center.

Timeline

Screening 0 days

Treatment Varies

Follow Up 0 days

Awards & highlights

No Placebo-Only Group

Summary

This trial uses special imaging agents to help visualize harmful brain proteins in people at risk of Alzheimer's disease. The agents make these proteins glow during scans, allowing doctors to see them clearly and monitor the disease.

Who is the study for?

This trial is for people aged 50-90 with no cognitive impairment, mild cognitive impairment, or Alzheimer's disease. They must be able to undergo repeated MR/PET imaging and have someone who can report on their functioning. Pregnant women and those unable to consent or at increased risk due to other conditions/medications are excluded.

What is being tested?

The study aims to compare tau PET radiopharmaceuticals Flortaucipir and MK-6240 in measuring tau tangles in the brain related to Alzheimer's. It will help understand how these tracers can be used in clinical settings by integrating their estimates.

What are the potential side effects?

While not explicitly listed, potential side effects may include discomfort from the imaging process, allergic reactions to tracers, and temporary side effects from radiation exposure such as nausea.

Eligibility Criteria

Inclusion Criteria

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

Select...

I am willing and able to have multiple MR/PET scans.

Timeline

Screening ~ 0 days1 visit

Treatment ~ Varies

Follow Up ~ 0 days5 visits

Screening ~ 0 days

Treatment ~ Varies

Follow Up ~0 days

This trial's timeline: 0 days for screening, Varies for treatment, and 0 days for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Cross-sectional tau PET uptake values

Longitudinal change in tau PET uptake values over 18 months

Secondary study objectives

Associations of tau PET uptake values blood biomarkers

Associations of tau PET uptake values with amyloid-β PET uptake values

Associations of tau PET uptake values with measures of cognition

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: Individuals across the aging and Alzheimer's disease (AD) spectrumExperimental Treatment3 Interventions

Approximately 620 individuals (40 young healthy, 280 cognitively unimpaired older, 200 mild cognitive impairment, and 100 Alzheimer's disease dementia) will be enrolled in the HEAD study.

0 / 6Eligibility 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 and tau PET radiopharmaceuticals. Cholinesterase inhibitors, such as donepezil, rivastigmine, and galantamine, increase cholinergic transmission by inhibiting the enzyme cholinesterase, leading to modest improvements in cognition and global functioning. Tau PET radiopharmaceuticals like Flortaucipir and MK-6240 are used to measure tau tangles, a key feature of AD pathology, aiding in diagnosis and monitoring disease progression. These treatments are important as they help manage symptoms and track the effectiveness of therapeutic interventions in AD patients.