Brain imaging to understand early changes in dementia related diseases

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Barcelonabeta Brain Research Center

Participant type

Patients, Healthy volunteers

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Nervous System Diseases [C10]

Decision date (initial)

2026-03-24

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Funding sources

ADDF · Life Molecular Imaging

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Others

1-To acquire [18F]F-DED PET in participants of the Barcelona-based cohorts, as detailed in section 4.4.
2- To characterize [18F]F-DED uptake in participants within the AD continuum and other neurodegenerative diseases.

Secondary objectives 4

1. To study the role of [18F]F-DED uptake on different AD disease stages and neurodegenerative diseases.
2. To define the relationship between [18F]F-DED uptake and known risk factors for ADRD.
3. To study the relation between [18F]F-DED uptake and core neurodegenerative-related pathologies.
4. To explore methodological aspects influencing the quantification of [18F]F-DED and its applicability in a clinical context.

Conditions and MedDRA coding

Dementia

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 6

1. 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.
2. Men and women who have participated in a Barcelona-based cohort as described in section 4.4 of this protocol.
3. Age between 18 and 99 years at the moment of inclusion in the Barcelona-based cohorts specified in section 4.4 of this protocol.
4. Participants with an available cerebral MRI within the last 18 months (and, if not available, willing to perform the MRI within the study).
5. 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.
6. Good knowledge of Spanish or Catalan.

Exclusion criteria 16

1. Current/active smoker
2. Active drug or alcohol abuse, as assessed in a Barcelona-based cohort as described in section 4.4 of this protocol.
3. Previous intolerance to PET studies.
4. 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.
5. Being pregnant or breast-feeding.
6. Inability to remain still in a supine position for 60 minutes.
7. Use of any MAO-B inhibitor, such as rasagiline, selegiline or salfinamide
8. 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.
9. Visual and/or hearing impairment.
10. 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.
11. 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)
12. 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.
13. 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
14. Any other clinically important condition that may jeopardize the study or be dangerous for the participant.
15. Known allergy or reaction or hypersensitivity to any of the components of the study formulation and/or products in the same class.
16. 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.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Non Applicable

Secondary endpoints 1

1. Non Applicable

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Barcelonabeta Brain Research Center

Sponsor organisation

Barcelonabeta Brain Research Center

Address

Calle De Wellington 30

City

Barcelona

Postcode

08005

Country

Spain

Scientific contact point

Organisation

Barcelonabeta Brain Research Center

Contact name

Gemma Salvadó

Public contact point

Organisation

Barcelonabeta Brain Research Center

Contact name

Gemma Salvadó

Locations

1 EU/EEA country · 4 investigational sites

By country

Investigational sites

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 17 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

2 submissions — initial application plus substantial / non-substantial modifications