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Study on Alzheimer's Disease Using Flortaucipir (18F) for Early Diagnosis in At-Risk Patients

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 is focused on studying Alzheimer's Disease, a condition that affects memory and thinking skills. The study will use a special imaging agent called 18F-Flortaucipir, which is a solution for injection. This agent helps in visualizing certain brain changes associated with Alzheimer's Disease. The purpose of the study is to explore the relationship between early brain changes and the risk of developing Alzheimer's Disease in the future.

Participants in the study will receive an injection of 18F-Flortaucipir and undergo various imaging tests, such as MRI (Magnetic Resonance Imaging) and PET (Positron Emission Tomography) scans. These tests will help researchers understand how early changes in the brain, particularly in a small area called the locus coeruleus, are linked to Alzheimer's Disease. The study will also look at how these changes affect thinking and memory over time.

The study will take place over several years, with follow-up assessments at 12 and 24 months to monitor any changes in brain function and cognitive performance. By examining these early brain changes, researchers hope to improve the understanding of Alzheimer's Disease and potentially aid in its early diagnosis. Participants will be divided into groups based on certain genetic factors, and their results will be compared to see if there are differences in how the disease progresses.

The research process

The trial runs in 7 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Upon joining the study, eligibility is confirmed based on criteria such as age, cognitive assessment, and health status.

    Consent is required before any study-related procedures begin.

  2. Step 2

    Initial assessment

    An initial assessment is conducted to establish baseline measurements. This includes cognitive tests and evaluations of visual and motor skills.

  3. Step 3

    Administration of 18F-Flortaucipir

    The medication 18F-Flortaucipir is administered as a solution for injection through an intravenous route.

    This step is crucial for imaging procedures that follow.

  4. Step 4

    Imaging procedures

    Imaging techniques such as functional MRI and structural MRI are used to assess brain regions of interest.

    These procedures help in understanding the relationship between brain function and Alzheimer's disease risk.

  5. Step 5

    Oculometry and pupillometry tests

    Tests are conducted to measure eye movements and pupil responses.

    These tests provide additional data on brain function and are repeated at various intervals.

  6. Step 6

    Follow-up assessments

    Follow-up assessments occur at 12 and 24 months to monitor changes over time.

    These assessments include repeated imaging and cognitive tests to track any progression or changes.

  7. Step 7

    Data analysis and conclusion

    Data collected throughout the study is analyzed to evaluate the effectiveness of biomarkers in predicting Alzheimer's disease risk.

    The study aims to improve early diagnosis and understanding of Alzheimer's disease.

Who can join the trial?

9 criteria

  • Must be **60 years old or older**.
  • Must be a participant in the **INSPIRE-T cohort** (a group of people being studied).
  • Must have a **normal cognitive assessment**, meaning their thinking and memory are normal.
  • Must have a **MMSE score of 27 or higher out of 30**. The MMSE, or Mini-Mental State Examination, is a test that checks mental functions like memory and understanding.
  • Must have **normal visual abilities**, whether with or without glasses or contact lenses.
  • Must have **normal motor skills**, meaning they can move normally.
  • Must provide **free, informed, and written consent**. This means they agree to participate after understanding the study, and they sign a form to confirm this.
  • Must be **affiliated with or benefiting from a social security scheme**, which means they have some form of social security coverage.
  • For participants in the **ApoE4 group only**: Must have the **ApoE4 allele**. This is a specific version of a gene related to the ApoE protein, identified as part of the INSPIRE project.

Who cannot join the trial?

4 criteria

  • Individuals who do not have a diagnosis of Alzheimer's Disease cannot participate. Alzheimer's Disease is a condition that affects memory and other mental functions.
  • Participants must be within a certain age range, typically adults and older adults.
  • Both males and females are eligible to participate, so gender is not a reason for exclusion.
  • Individuals who are considered part of a vulnerable population, such as those who cannot give consent or are at higher risk, are not included in this study.
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Investigated drugs

LocusTau is a medication being studied to understand its effects on biomarkers related to the locus coeruleus nucleus. This study aims to explore how these biomarkers are linked to early tau pathology, cognitive function, and the risk of developing Alzheimer's disease. The goal is to determine if these biomarkers can help in diagnosing Alzheimer's disease at its earliest stages.

What is already known about the treatment

Donepezil – Donepezil is administered orally in tablet form and is commonly used in the treatment of Alzheimer's Disease. It is currently well-established in medical practice and literature as a treatment option for managing symptoms of this condition. The main therapeutic indication for Donepezil is to improve cognitive function in individuals with Alzheimer's Disease. At the molecular level, Donepezil works by inhibiting the enzyme acetylcholinesterase, which increases the levels of acetylcholine in the brain, thereby enhancing communication between nerve cells. It is classified pharmacologically as a cholinesterase inhibitor.

Investigated diseases

Alzheimer's Disease – Alzheimer's Disease is a progressive neurological disorder that leads to the degeneration and death of brain cells. It is characterized by a gradual decline in memory, thinking, and reasoning skills. As the disease progresses, individuals may experience confusion, mood changes, and difficulty with language and daily tasks. The progression of Alzheimer's involves the accumulation of abnormal protein deposits in the brain, such as amyloid plaques and tau tangles, which disrupt cell function. Over time, this leads to significant brain shrinkage and loss of cognitive abilities. The disease typically affects older adults, but early-onset forms can occur in younger individuals.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2023-507668-38-00Protocol codeRC31/23-0371Estimated enrolment100 patientsSponsorCentre Hospitalier Universitaire De Toulouse

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