[18F]DED for Dementia|CADASIL|Late-onset Alzheimer's disease|Autosomal dominant Alzheimer's disease|Early-onset sporadic Alzheimer's disease

Inclusion criteria

• {"criterion_text":"- 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."}
• {"criterion_text":"- Men and women who have participated in a Barcelona-based cohort as described in section 4.4 of this protocol."}
• {"criterion_text":"- Age between 18 and 99 years at the moment of inclusion in the Barcelona-based cohorts specified in section 4.4 of this protocol."}
• {"criterion_text":"- Participants with an available cerebral MRI within the last 18 months (and, if not available, willing to perform the MRI within the study)."}
• {"criterion_text":"- 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."}
• {"criterion_text":"- Good knowledge of Spanish or Catalan."}

Exclusion criteria

• {"criterion_text":"- Current/active smoker"}
• {"criterion_text":"- 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."}
• {"criterion_text":"- 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)"}
• {"criterion_text":"- 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."}
• {"criterion_text":"- Clinically relevant renal or hepatic insufficiency, defined as having one or more of the following laboratory test results: •\tAlanine aminotransferase (ALT) ≥ 2.5 x upper limit of normal (ULN) •\tAspartate aminotransferase (AST) ≥ 2.5 x ULN •\tTotal bilirubin (TBL) ≥ 1.5 x ULN •\tAlkaline phosphatase (ALP) ≥ 2 x ULN Estimated glomerular filtration rate (eGFR) < 60 mL/min"}
• {"criterion_text":"- Any other clinically important condition that may jeopardize the study or be dangerous for the participant."}
• {"criterion_text":"- Known allergy or reaction or hypersensitivity to any of the components of the study formulation and/or products in the same class."}
• {"criterion_text":"- 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."}
• {"criterion_text":"- Active drug or alcohol abuse, as assessed in a Barcelona-based cohort as described in section 4.4 of this protocol."}
• {"criterion_text":"- Previous intolerance to PET studies."}
• {"criterion_text":"- 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."}
• {"criterion_text":"- Being pregnant or breast-feeding."}
• {"criterion_text":"- Inability to remain still in a supine position for 60 minutes."}
• {"criterion_text":"- Use of any MAO-B inhibitor, such as rasagiline, selegiline or salfinamide"}
• {"criterion_text":"- 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."}
• {"criterion_text":"- Visual and/or hearing impairment."}

Primary endpoints

• {"endpoint_text":"- Non Applicable","definition_or_measurement_approach":""}

Secondary endpoints

• {"endpoint_text":"- Non Applicable","definition_or_measurement_approach":""}

Methods

• Recruitment from Barcelona-based cohorts as described in section 4.4 of the protocol (participants must have participated in specified Barcelona-based cohorts).

Spain

Earliest CTIS Part Ii Submission Date

05-03-2026

Latest Decision Or Authorization Date

24-03-2026

Processing Time Days

19

Number Of Sites

4

Number Of Participants

300

Primary sponsor

Full Name

Barcelonabeta Brain Research Center

Organisation Type

Laboratory/Research/Testing facility

Country Of Registered Address

Spain

Third parties

• {"country":"","full_name":"ADDF","duties_or_roles":"Monetary support","organisation_type":""}
• {"country":"","full_name":"Life Molecular Imaging","duties_or_roles":"Monetary support / supplier of investigational radiopharmaceutical","organisation_type":""}