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Study on Brain Imaging for Alzheimer's Disease Using Florquinitau (18F) in Patients with Mild Cognitive Impairment and Early Alzheimer's Symptoms

Verified siteInvestigationalNo placebo
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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial focuses on studying Alzheimer's disease and related conditions. The study uses a special imaging technique called PET/CT to look at the brain. The main goal is to see how a protein called p-TAU builds up in the brain. The study uses a substance called F18-MK6240, which is a solution for injection, to help with the imaging process. This substance is injected into the body and helps highlight areas in the brain where the protein might be accumulating.

The trial involves people with different conditions, including those with mild cognitive impairment, early Alzheimer's, and other neurodegenerative disorders. It also includes a group of people without these conditions to compare the results. The study aims to understand how the protein deposits differ between these groups. Participants will undergo brain imaging using the F18-MK6240 to help researchers gather this information.

Throughout the study, participants will have several imaging sessions to track changes in the brain over time. The results will help researchers learn more about how these diseases progress and how they affect the brain. This information could be important for developing new treatments in the future. The study is expected to continue for several years to gather comprehensive data.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial visit

    Upon joining the study, an initial visit is scheduled. During this visit, a detailed explanation of the study is provided, and any questions are addressed. Consent forms are reviewed and signed to confirm participation.

    A comprehensive medical history is taken, and a physical examination is conducted to ensure eligibility for the study.

  2. Step 2

    Baseline assessments

    Baseline assessments are conducted to gather initial data. These assessments may include cognitive tests to evaluate memory, attention, and other mental functions.

    An amyloid-PET scan or a CSF measure of Aβ-42 may be performed to assess brain health. These tests help in understanding the presence of certain proteins associated with Alzheimer's disease.

  3. Step 3

    Administration of F18-MK6240

    The study involves the administration of a solution called F18-MK6240. This is given as an intravenous bolus, which means it is injected directly into a vein in a single, quick dose.

    This solution is used for PET/CT imaging to visualize certain proteins in the brain. The imaging helps in evaluating the regional deposition of tau protein aggregates.

  4. Step 4

    PET/CT imaging

    After the administration of F18-MK6240, a PET/CT scan is performed. This imaging process is non-invasive and helps in capturing detailed images of the brain.

    The scan provides information on the distribution of tau proteins, which are associated with neurodegenerative disorders like Alzheimer's disease.

  5. Step 5

    Follow-up visits

    Follow-up visits are scheduled to monitor health and gather additional data. These visits may include further cognitive assessments and discussions about any changes in health.

    Additional imaging or tests may be conducted as needed to track progress and gather comprehensive data for the study.

  6. Step 6

    Study completion

    Upon completion of the study, a final visit is conducted. During this visit, results and findings are discussed, and any remaining questions are addressed.

    Participants are thanked for their contribution to the study, and any necessary follow-up care is arranged.

Who can join the trial?

12 criteria

  • Patients with MCI (Mild Cognitive Impairment) due to AD (Alzheimer's Disease) or mild AD: Age at least 45 years.
  • Have attended specific clinics such as the Memory Clinic, Stroke Clinic, Neuromuscular Clinic, or Movement Disorder Clinic.
  • Are able to give consent and willing to participate in the study.
  • Are clinically suspected to have certain conditions like cerebral amyloid angiopathy, Fronto-temporal Lobar Degeneration, Progressive Supranuclear Palsy, Corticobasal Degeneration, Lewy body disease, or Amyotrophic Lateral Sclerosis.
  • Have a study partner or can identify someone willing to be a study partner.
  • Non-demented controls: Age at least 20 years.
  • Able to read and write in French, with at least 5 years of formal education.
  • Have normal cognition as defined by an MMSE (Mini-Mental State Examination) score of 26/30 or higher (25/30 if education is lower than high school).
  • Have an available amyloid-PET scan or a CSF (Cerebrospinal Fluid) measure of Aβ-42, or are willing to undertake these tests for the study.
  • Are diagnosed with mild cognitive impairment using the Petersen criteria or with mild AD dementia using the McKhann criteria by a clinical neurologist.
  • Have either a positive amyloid-PET scan, an abnormal measure of Aβ-42 in the CSF, or an abnormal ratio between total tau and Aβ-42 in the CSF.
  • Patients with non-AD syndrome: Age at least 20 years.

Who cannot join the trial?

5 criteria

  • Patients who do not have Alzheimer's disease or other neurodegenerative disorders cannot participate.
  • Patients who are not within the specified age range cannot participate.
  • Patients who are not part of the specified clinical trial groups cannot participate.
  • Patients who are not male or female cannot participate.
  • Patients who are not considered part of a vulnerable population cannot participate.
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Investigated drugs

F18-MK6240 is a special type of imaging agent used in this clinical trial. It helps doctors see inside the brain by using a PET/CT scan. This agent is designed to attach to certain proteins in the brain called p-TAU protein aggregates. These proteins can build up in the brains of people with neurodegenerative disorders like Alzheimer's disease. By using F18-MK6240, doctors can get a clearer picture of how these proteins are distributed in the brain, which can help in understanding and diagnosing conditions like Alzheimer's disease and other related syndromes.

What is already known about the treatment

F18-MK6240 – This medication is administered through a PET/CT scan, which is a type of imaging test that helps visualize the brain. Currently, F18-MK6240 is being studied in clinical trials to understand its role in detecting Alzheimer's disease and other neurodegenerative disorders. It is primarily used to identify the presence of tau protein aggregates in the brain, which are associated with Alzheimer's disease. At the molecular level, F18-MK6240 binds to tau proteins, allowing doctors to see where these proteins are accumulating in the brain. This medication falls under the category of diagnostic agents used in imaging.

Investigated diseases

Alzheimer's disease – Alzheimer's disease is a progressive neurodegenerative disorder characterized by the gradual decline in cognitive functions, including memory, reasoning, and language skills. It typically begins with mild memory loss and confusion, which can lead to difficulties in recognizing familiar people and places. As the disease advances, individuals may experience significant changes in behavior and personality, such as increased irritability, anxiety, and depression. The progression of Alzheimer's disease involves the accumulation of abnormal protein deposits in the brain, including amyloid plaques and tau tangles, which disrupt communication between nerve cells. Over time, these changes result in the loss of brain tissue and the impairment of essential bodily functions. The disease primarily affects older adults, with symptoms worsening over several years.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IVTrial ID2024-517074-17-00Protocol codeUCL-2016-121Estimated enrolment500 patientsSponsorCliniques Universitaires Saint-Luc

sourced from the EU Clinical Trials Register and site verification

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