Characterization of Astrocyte Reactivity Using [18F]F-DED PET Imaging in Alzheimer's Disease and Other Neurodegenerative Disorders

Trial ID: 2025-523284-37-00
Protocol: Astrocyte-PET/BBRC
Sponsor: Barcelonabeta Brain Research Center

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Diseases & Conditions

Dementia CADASIL Dementia Alzheimer's type Prodromal Alzheimer's disease

Objectives

The primary objective is to characterize astrocyte reactivity through [18F]F-DED PET imaging in individuals within the Alzheimer's disease continuum and other neurodegenerative diseases. This evaluation aims to assess the uptake of the tracer to better understand pathological processes in the brain. Secondary objectives include:

Investigating the role of tracer uptake across different stages of neurodegeneration and relevant biological processes.
Defining the relationship between tracer uptake and established biomarkers for Alzheimer's disease-related dementia.
Analyzing the association between tracer uptake and core clinical and cognitive aspects of the participants.
Exploring methodological factors affecting the quantification of tracer uptake for potential clinical application.

Participants

The sponsor did not provide information regarding the total number of participants. The study population consists of both patients and healthy volunteers, including men and women. The cohort encompasses individuals diagnosed with dementia, CADASIL, late onset Alzheimer disease, autosomal dominant Alzheimer's disease, or sporadic early onset Alzheimer disease. Participants must be between 18 and 99 years of age. Inclusion requires written informed consent, a known cognitive status, and an available or upcoming cerebral MRI. Proficiency in Spanish or Catalan is required. The objectives of the study are:

To acquire [18F]F-DED PET imaging in the specified cohorts.
To characterize [18F]F-DED uptake within the Alzheimer's disease continuum and other neurodegenerative diseases.

Plans and Procedures

This Phase II clinical trial is designed to characterize astrocyte reactivity using [18F]DED positron emission tomography (PET) in individuals with neurodegenerative diseases. The research focuses on characterizing the uptake of the tracer within the Alzheimer disease continuum and other conditions, including CADASIL. The study involves the intravenous bolus injection of a solution for injection containing 240,000,000 Bq of [18F]DED. Eligible participants must be part of specific cohorts, aged between 18 and 99 years, with a documented cognitive status and available cerebral MRI. The study duration is estimated to occur between May 2026 and September 2030.

Treatment

The experimental substance is [18F]DED, which is prepared as a solution for injection. This radiopharmaceutical is administered via intravenous bolus injection or intravenous infusion at a dose of 240,000,000 Bq. The administration is utilized for positron emission tomography to characterize astrocyte reactivity in participants with neurodegenerative diseases and those within the Alzheimer's disease continuum.

Efficacy

The clinical trial aims to characterize astrocyte reactivity through the acquisition of [18F]F-DED PET imaging. The investigation focuses on assessing [18F]F-DED uptake in cohorts representing the Alzheimer's disease continuum and other neurodegenerative diseases, including dementia, CADASIL, late onset Alzheimer disease, autosomal dominant Alzheimer's disease, and sporadic early onset Alzheimer disease.

Inclusion and Exclusion Criteria

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Inclusion Criteria

Provide written informed consent, approved by the relevant authorities, signed by the participant or the participant’s legally authorized representative, systematically with the participant’s assent.
Men and women who have participated in a Barcelona-based cohort as described in section 4.4 of this protocol.
Age between 18 and 99 years at the moment of inclusion in the Barcelona-based cohorts specified in section 4.4 of this protocol.
Participants with an available cerebral MRI within the last 18 months (and, if not available, willing to perform the MRI within the study).
Known cognitive status based on the cognitive workup of the Barcelona-based cohorts specified in section 4.4 of this protocol. Cognitive status may have been determined within the last 12 months.
Good knowledge of Spanish or Catalan.

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Exclusion Criteria

Current/active smoker
Active drug or alcohol abuse, as assessed in a Barcelona-based cohort as described in section 4.4 of this protocol.
Previous intolerance to PET studies.
Women of childbearing potential (defined as women following menarche and until becoming post-menopausal unless permanently sterile; permanent sterilization methods include hysterectomy, bilateral salpingectomy and bilateral oophorectomy), also known as fertile women, except if they produce a negative pregnancy test on the day of the visit or if a highly effective method of contraception has been used without interruptions in the past 9 months. Such methods include: combined (estrogen and progestogen) hormonal contraception, progestogen-only hormonal contraception, intrauterine device (IUD), intrauterine hormone-releasing system (IUS), bilateral tubal occlusion, vasectomised partner and sexual abstinence. At the investigator's criteria, a pregnancy test can be performed in all cases.
Being pregnant or breast-feeding.
Inability to remain still in a supine position for 60 minutes.
Use of any MAO-B inhibitor, such as rasagiline, selegiline or salfinamide
Presence of clinically relevant psychiatric disorder according to the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-V) criteria: major depressive disorder, generalized anxiety disorder, schizophrenia, and bipolar disorder, as assessed in the BBRC-sponsored studies specified above.
Visual and/or hearing impairment.
History of encephalitis, ictus, or seizures excluding feverish convulsions during childhood, as assessed in a Barcelona-based cohort as described in section 4.4 of this protocol.
Clinically relevant incidental findings on the screening MRI, such as Severe severe cerebral macrovascular (i.e., multi-stroke) disease or brain tumour (metastasis/brain cancer)
Previous participation in a clinical study involving an investigational pharmaceutical product within 30 days prior to screening and/or administration of a radiopharmaceutical within 10 radioactive half-lives prior to study drug administration in this study.
Clinically relevant renal or hepatic insufficiency, defined as having one or more of the following laboratory test results: • Alanine aminotransferase (ALT) ≥ 2.5 x upper limit of normal (ULN) • Aspartate aminotransferase (AST) ≥ 2.5 x ULN • Total bilirubin (TBL) ≥ 1.5 x ULN • Alkaline phosphatase (ALP) ≥ 2 x ULN Estimated glomerular filtration rate (eGFR) < 60 mL/min
Any other clinically important condition that may jeopardize the study or be dangerous for the participant.
Known allergy or reaction or hypersensitivity to any of the components of the study formulation and/or products in the same class.
If a previous MRI is not available, presence of implants or devices incompatible with MRI (e.g., peacemakers, defibrillators or stimulators, metallic aneurysm clips, cochlear implants, metallic body fragments, external chargers, infusion pumps, or active prostheses), as well as extreme overweight or body dimensions that would prevent safe use of the MRI system.