Study on How Florquinitau (18F) Affects Brain Circuits in Early Alzheimer’s Disease Stages

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What is this study about?

This clinical trial is focused on studying Alzheimer’s disease, particularly in its early stages, which include the preclinical and prodromal phases. The study aims to understand how a protein called tau spreads in the brain and affects the brain’s language circuits. The treatment being used in this study is a special type of imaging agent called [18F]MK-6240, which is a sterile solution containing a substance known as florquinitau (18F). This agent is administered through an intravenous injection, which means it is injected directly into the bloodstream.

The purpose of the study is to explore how the spread of tau in the brain affects its function, especially in areas related to language. Participants in the study will include individuals with mild to moderate Alzheimer’s disease, those with mild cognitive impairment due to Alzheimer’s, and healthy individuals with and without amyloid, a protein associated with Alzheimer’s. The study will observe how tau affects brain activity and connectivity, which refers to how different parts of the brain communicate with each other.

Throughout the study, participants will receive the imaging agent and undergo various assessments to monitor changes in brain function. The study will help researchers gain a better understanding of Alzheimer’s disease and how it progresses, potentially leading to improved treatments in the future. Some participants may receive a placebo, which is a substance with no active ingredients, to compare the effects of the imaging agent.

1 initial visit

Upon joining the study, an initial visit is scheduled. During this visit, eligibility is confirmed based on specific criteria related to Alzheimer’s disease stages and cognitive health.

A series of assessments are conducted to evaluate cognitive function and overall health status. This includes tests like the Mini-Mental State Examination (MMSE) and the Clinical Dementia Rating scale.

2 administration of medication

The medication used in this study is a sterile solution called [18F]MK-6240. It is administered through an intravenous bolus injection or IV infusion.

The purpose of this medication is to help visualize the spread of tau proteins in the brain, which are associated with Alzheimer’s disease.

3 imaging sessions

Following the administration of the medication, imaging sessions are conducted. These sessions involve brain scans to observe the distribution of tau proteins.

The imaging helps in understanding how tau affects brain circuits, particularly those involved in language and cognitive functions.

4 follow-up visits

Regular follow-up visits are scheduled to monitor health and cognitive function. These visits ensure the safety and well-being of participants throughout the study.

Additional assessments may be conducted during these visits to gather more data on the effects of tau on brain activity.

5 completion of study

Upon completion of the study, a final visit is conducted. This visit includes a comprehensive assessment to evaluate any changes in cognitive function and overall health.

Participants are provided with information about the study findings and any relevant health recommendations.

Who Can Join the Study?

Participants must have a diagnosis of Alzheimer’s disease in its early stages, which includes preclinical (before symptoms appear) and prodromal (early symptoms) stages.
Participants can be patients with mild to moderate Alzheimer’s disease, as determined by specific diagnostic criteria. They should have a Mini-Mental State Examination (MMSE) score of 16 or higher. The MMSE is a test that measures cognitive function.
Participants can also be patients with amnestic Mild Cognitive Impairment (MCI) due to Alzheimer’s disease. Amnestic MCI is a condition where memory problems are more significant than expected for a person’s age. These participants should have an MMSE score of 25 or higher.
Participants can be healthy individuals who are amyloid-positive. Amyloid is a protein that can build up in the brain and is associated with Alzheimer’s disease. These individuals should be cognitively intact, meaning they do not have memory or thinking problems.
Participants can also be healthy individuals who are amyloid-negative, meaning they do not have a build-up of amyloid protein in the brain. These individuals will be matched in age, education, and gender to the other groups in the study.
Participants should be between the ages of 55 and 80 years old.
Both male and female participants are eligible to join the study.

Who Cannot Join the Study?

Patients who do not have Alzheimer’s disease in the early stages cannot participate.
Patients who are not in the preclinical or prodromal stages of Alzheimer’s disease cannot participate. Preclinical means before symptoms appear, and prodromal means early symptoms are present but not yet full-blown.
Patients who are not in the early dementia phase of Alzheimer’s disease cannot participate. Early dementia phase refers to the initial stage where memory and thinking problems start to interfere with daily life.
Patients who are not within the specified age range cannot participate. The age range is typically defined by the study but is not specified here.
Patients who are part of a vulnerable population cannot participate. This means groups that might need special protection, like children or those unable to give consent, are not included.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
Katholieke Universiteit te Leuven	Leuven	Belgium

Other Sites

No sites found in this category

Trial status

Country	Status	Recruitment Start
Belgium	Recruiting	11.01.2019

Trial locations

Investigated drugs:

Florquinitau (18F)

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“productName”: “LMTX”,
“description”: “LMTX is a medication being studied for its potential to slow down the progression of Alzheimer’s disease. It is believed to work by preventing the buildup of tau proteins in the brain, which are associated with the development of Alzheimer’s. By reducing these proteins, LMTX may help maintain brain function and slow memory loss.”
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“productName”: “Aducanumab”,
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LMTX is a medication being studied for its potential to slow down the progression of Alzheimer’s disease. It is believed to work by preventing the buildup of tau proteins in the brain, which are associated with the development of Alzheimer’s. By reducing these proteins, LMTX may help maintain brain function and slow memory loss.

Aducanumab is a medication designed to target and remove amyloid plaques in the brain, which are thought to contribute to Alzheimer’s disease. By clearing these plaques, Aducanumab aims to slow the progression of the disease and preserve cognitive function in patients.

Investigated diseases:

Dementia Alzheimer's type

Alzheimer’s Disease – Alzheimer’s Disease is a progressive neurological disorder that affects memory, thinking, and behavior. In its early stages, individuals may experience mild memory loss and confusion. As the disease progresses, it leads to more severe memory impairment, disorientation, and difficulty in performing daily tasks. The disease is characterized by the accumulation of tau protein aggregates and amyloid plaques in the brain, which disrupt normal brain function. Over time, individuals may experience changes in personality and behavior, and eventually, they may lose the ability to communicate and recognize loved ones. The progression of Alzheimer’s Disease varies among individuals, but it generally leads to a decline in cognitive and functional abilities.

Trial ID:

2024-511613-38-01

Trial Phase:

Human Pharmacology (Phase I) – Other

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Study on How Florquinitau (18F) Affects Brain Circuits in Early Alzheimer’s Disease Stages

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