Overview
Sponsor-declared trial summary
Phase
Therapeutic exploratory (Phase II)
Status
Authorised, recruiting
Participants planned
200
Countries
1
Sites
1
Alzheimer's Disease
Characterize tau tracer retention as a function of amyloid levels transversally and longitudinally.
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
- Health Care [N] - Population Characteristics [N01]
- Trial duration
- 18 Dec 2024 → ongoing
- Decision date (initial)
- 2024-12-18
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
- Funding sources
- F. HOFFMANN-LA ROCHE LTD
External identifiers
- EU CT number
- 2024-516209-21-00
- EudraCT number
- 2019-004290-84
- ClinicalTrials.gov
- NCT04482660
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Others
Characterize tau tracer retention as a function of amyloid levels transversally and longitudinally.
Conditions and MedDRA coding
Alzheimer's Disease
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 8
- To sign the study informed consent form approved by the corresponding authorities
- Men and women that have participated in a BBRC-sponsored study, including the ALFA project (STUDY 45-65 FPM/2012), the ALFA+ cohort study (ALFA - FPM - 0311), the ALFA cognition study (ALFAcognition/BBRC2017), the BarcelonaBeta Dementia Prevention Research Clinic study (BBRC-DemPrev-2018) or the βETA-AARC study (β-AARC_BBRC2021)
- Age between 45 and 80 years at the moment of inclusion in the BBRC-sponsored studies specified above
- Participants with an available cerebral MRI within the last 12 months not suggestive of radiological incidental findings constituting an exclusion criterion
- Known cognitive status based on the cognitive workup of the BBRC-sponsored studies specified above. Cognitive status may have been determined within the last 12 months
- Known AB and tau status
- Good knowledge of the language and being literate
- Female participants should be post-menopausal or present a negative pregnancy test at the moment of PET acquisition
Exclusion criteria 10
- 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 the BBRC-sponsored studies specified above
- Severe cerebral macrovascular (i.e., multi-stroke) disease or brain tumour (metastasis/brain cancer) as verified by MRI
- 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 important condition that may jeopardize the study or be dangerous for the participant
- Active drug or alcohol abuse, as assessed in the BBRC-sponsored studies specified above
- Previous intolerance to PET studies or known hypersensitivity to 18F-RO6958948
- Being pregnant or breast-feeding
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Global and regional retention rate of 18F-RO6958948
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
2-6-18FFLUORO-PYRIDIN-3-YL-9H-DIPYRIDO23-B34-DPYRROLE
PRD11158263 · Product
- Active substance
- 2-6-18FFLUORO-PYRIDIN-3-YL-9H-DIPYRIDO23-B34-DPYRROLE
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- INTRAVENOUS BOLUS INJECTION/IV INFUSION
- Max daily dose
- 370 MBq megabecquerel(s)
- Max total dose
- 10 Aµg microgram(s)
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Not Authorised
- MA holder
- FUNDACIO INSTITUT DE RECERCA DE L HOSPITAL DE LA SANTA CREU I SANT PAU
- Paediatric formulation
- No
- Orphan designation
- 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
- Principal Investigator
Public contact point
- Organisation
- Barcelonabeta Brain Research Center
- Contact name
- Principal Investigator
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Spain | Authorised, recruiting | 200 | 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 | 2024-12-18 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 12 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_Protocol EU CT 2024-516209-21-00_SM1 _V7_16OCT2025_TC | 7 |
| Protocol (for publication) | D1_Protocol EU CT 2024-516209-21-00_SM1_V7_16OCT2025_CLEAN | 7 |
| Protocol (for publication) | D1_Protocol_2019-004290-84 | 6.0 |
| Recruitment arrangements (for publication) | Blank doc for CTIS placeholders_Doc assessed under EUCTD | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements_ESP_en | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF description_v4_CAT | 4 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF description_v4_ESP | 4 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Catalan_BBRC_SM1_v5_16Oct2025_CLEAN | 5 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Catalan_BBRC_SM1_v5_16Oct2025_TC | 5 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Espanol_BBRC_SM1_v5_16Oct2025_CLEAN | 5 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Espanol_BBRC_SM1_v5_16Oct2025_TC | 5 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis ESP_2019-004290-84_es | 6 |
Application history
2 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-12-11 | Spain | Acceptable 2024-12-18
|
2024-12-18 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2026-01-09 | Spain | Acceptable 2026-02-23
|
2026-03-31 |