Overview
Sponsor-declared trial summary
Phase
Therapeutic use (Phase IV)
Status
Authorised, recruiting
Participants planned
400
Countries
1
Sites
1
Alzheimer's Disease
To determine the prevalence and progression of positive 18F-Flutemetamol scans in individuals recruited in the ALFA project
Key facts
- Sponsor
- Barcelonabeta Brain Research Center
- Participant type
- Healthy volunteers, Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Health Care [N] - Population Characteristics [N01]
- Trial duration
- 25 Jan 2025 → ongoing
- Decision date (initial)
- 2025-01-20
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
- Funding sources
- General Electric (GE Healthcare Bio-Sciences, SAU)
External identifiers
- EU CT number
- 2024-519961-23-00
- EudraCT number
- 2015-004474-15
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Others
To determine the prevalence and progression of positive 18F-Flutemetamol scans in individuals recruited in the ALFA project
Secondary objectives 1
- To determine the prevalence of the different stages of preclinical AD according to the NIA-AA criteria
Conditions and MedDRA coding
Alzheimer's Disease
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 7
- To sign the study informed consent form approved by the corresponding authorities
- Men and women enrolled in the STUDY 45-65 FPM/2012
- Participants with a cerebral MRI (magnetic resonance imaging) not suggestive of radiological incidental findings constituting an exclusion criterion
- Cognition within psychometric normal ranges: MMSE (Mini Mental State Examination ≥26 and Verbal Semantic Fluency (animals) ≥12) at baseline
- Score of 0 in the CDR scale (Clinical Dementia Rating) at baseline
- Good knowledge of Spanish or Catalan and being literate
- Female participants should be post-menopausal or present a negative pregnancy test at the moment of PET realization
Exclusion criteria 13
- To present cognitive impairment at baseline
- 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
- Individuals with visual and/or hearing impairment
- History of encephalitis, ictus, or seizures excluding feverish convulsions during childhood
- Severe cerebral macrovascular (i.e., multi-stroke) disease or brain tumour (metastasis/brain cancer) as verified by magnetic resonance imaging (MRI)
- Any contraindication to MRI acquisition, (i.e., metal implants) or phobia to performing the scan as determined by the onsite physician
- 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
- Any other clinically significant condition that may jeopardize the study or be dangerous for the participant
- Active drug or alcohol abuse
- Presence of a pacemaker, aneurysm graft, artificial heart valves, auditory implants, cerebral shunts, metal fragments, or strange objects in the eyes, skin, or body that may contraindicate magnetic resonance imaging
- Previous intolerance to PET studies or known hypersensitivity to 18F-Flutemetamol or 18F-FDG
- Being pregnant or breast-feeding
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Participants with a mean cortex activity SUVr (cerebellar cortex) over 1.56 in 18F-Flutemetamol PET will be classified as positive and, otherwise, as negative for cerebral amyloid deposition. Prevalence of positive 18F-Flutemetamol PET will be determined by age, sex, APOE genotype, and familiar history of AD.
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 2
VIZAMYL 400 MBq/mL solution for injection
PRD10888598 · Product
- Active substance
- Flutemetamol (18F)
- Substance synonyms
- Flutemetamol F 18, FLUTEMETAMOL F-18
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- INTRAVENOUS ADMINISTRATION
- Max daily dose
- 185 MBq megabecquerel(s)
- Max total dose
- 185 MBq megabecquerel(s)
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- V09AX04 — -
- Marketing authorisation
- EU/1/14/941/001
- MA holder
- GE HEALTHCARE AS
- MA country
- Liechtenstein
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
BARNASCAN 3000 MBq/ml solución inyectable
PRD11853652 · Product
- Active substance
- Fludeoxyglucose (18F)
- Substance synonyms
- FLUDEOXYGLUCOSE F 18, FLUORODEOXYGLUCOSE F18, ALPHA-D-GLUCOPYRANOSE, 2-DEOXY-2-(FLUORO-18F), 18F-FLUDEOXYGLUCOSE
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- INTRAVENOUS INJECTION
- Max daily dose
- 400 MBq megabecquerel(s)
- Max total dose
- 400 MBq megabecquerel(s)
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- V09IX04 — -
- Marketing authorisation
- 68016
- MA holder
- ADVANCED ACCELERATOR APPLICATIONS IBÉRICA, S.L.U
- MA country
- Spain
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Barcelonabeta Brain Research Center
- Sponsor organisation
- Barcelonabeta Brain Research Center
- Address
- Calle Wellington 30
- City
- Barcelona
- Postcode
- 08005
- Country
- Spain
Scientific contact point
- Organisation
- Barcelonabeta Brain Research Center
- Contact name
- Oriol Grau
Public contact point
- Organisation
- Barcelonabeta Brain Research Center
- Contact name
- Oriol Grau
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Spain | Authorised, recruiting | 400 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| Spain | 2025-01-25 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 9 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_Protocol_2015-004474-15 | 8 |
| Recruitment arrangements (for publication) | Blank doc for CTIS placeholders_Doc assessed under EUCTD | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF description_v5_CAT | 5 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF description_v5_ESP | 5 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Cesion de Datos_CAT_BBRC_SM1_V1_24mar2026_PET18F_CLEAN | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Cesion de Datos_ESP_BBRC_SM1_V1_24mar2026_PET18F_CLEAN | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Barnascan | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Vizamyl | 1 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis _2015-004474-15_ | 8 |
Application history
3 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2025-01-10 | Spain | Acceptable 2025-01-20
|
2025-01-20 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2025-01-30 | Spain | Acceptable 2025-01-20
|
2025-01-30 |
| 3 | SUBSTANTIAL MODIFICATION | SM-1 | 2026-04-09 | Spain | Acceptable | 2026-05-13 |