Overview
Sponsor-declared trial summary
Phase
Therapeutic exploratory (Phase II)
Status
Ongoing, recruiting
Participants planned
150
Countries
1
Sites
1
cognitive impairment
Compare cross-sectional and longitudinal measures of tau obtained with these three second-generation PET tau tracers ([18F]RO948, [18F]PI2620, and [18F]MK-6240) directly in the same volunteers to elucidate the advantages and limitations of their use in research cohorts, clinical trials, and clinical practice.
Key facts
- Sponsor
- Fundacio Institut De Recerca De L Hospital De La Santa Creu I Sant Pau
- Participant type
- Patients, Healthy volunteers
- Age range
- 18-64 years
- Gender
- Male and Female
- Therapeutic area
- Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Diagnosis [E01], Diseases [C] - Nervous System Diseases [C10]
- Trial duration
- 1 Jul 2024 → ongoing
- Decision date (initial)
- 2024-06-19
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Diagnosis
Compare cross-sectional and longitudinal measures of tau obtained with these three second-generation PET tau tracers ([18F]RO948, [18F]PI2620, and [18F]MK-6240) directly in the same volunteers to elucidate the advantages and limitations of their use in research cohorts, clinical trials, and clinical practice.
Secondary objectives 3
- Compare the cross-sectional features of tau PET tracers.
- Compare the longitudinal progression of tau PET tracers over 18-24 months
- Test the associations between tau PET tracers and plasma biomarker values
Conditions and MedDRA coding
cognitive impairment
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.1 | LLT | 10009846 | Cognitive impairment | 10029205 |
Regulatory references
- Plan to share IPD
- No
| EU CT number | Title | Sponsor |
|---|---|---|
| 2023-510508-31-00 | Longitudinal multicenter head-to-head harmonization of tau PET tracers (HEAD Study) | Fundacio Institut De Recerca De L Hospital De La Santa Creu I Sant Pau |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 9
- For Healthy Cognitive Controls: Age: > 18 years (minimum N=5 young individuals aged between 18 and 28) Clinical Criterion: CDR = 0
- Mild Cognitive Impairment (MCI): Age: 50-90 years (inclusive) Clinical Criteria: NIA-AA 2018, MMSE (22-28)
- Alzheimer's Disease (AD): Age: 50-90 years (inclusive) Clinical Criteria: NIA-AA 2018, MMSE (11-24)
- Frontotemporal Dementia: Age: 50-90 years (inclusive) Clinical Criteria: Rascovsky et al., 2011
- Primary Progressive Aphasia: Age: 50-90 years (inclusive) Clinical Criteria: Gorno-Tempini et al., 2011
- Progressive Supranuclear Palsy: Age: 50-90 years (inclusive) Clinical Criteria: Hoglinger et al., 2017
- Corticobasal Degeneration: Age: 50-90 years (inclusive) Clinical Criteria: Armstrong et al., 2013
- Dementia with Lewy Bodies: Age: 50-90 years (inclusive) Clinical Criteria: McKeith et al., 2017
- Down's Syndrome (SD): Age: > 18 years
Exclusion criteria 1
- Patient with out inclusion criteria
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- The main outcome variable derived from the administration of the radiopharmaceutical will be the Standardized Uptake Value Ratio (SUVR) from different PET tau images, which will be co-registered with the structural MRI image. The lower cerebellar cortex will be used as a reference region
Secondary endpoints 12
- SUVR values obtained for different tracers.
- Voxel-wise and regional correlation analysis.
- Transformed values to standardize tau PET tracers to a common scale.
- Diagnostic performance among different groups.
- Associations of tau tracers with amyloid.
- Associations of tau tracers with brain atrophy.
- Associations of tau tracers with cognition.
- Associations of tau tracers with plasma tau biomarkers (p-tau181, p-tau-217, and p-tau231).
- Longitudinal tau accumulation rates among tracers.
- Associations between longitudinal changes in tau and amyloid deposition.
- Associations between longitudinal changes in tau and brain atrophy.
- Asociaciones entre los cambios longitudinales en tau y progresión en cognición.
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 3
2-6-18FFLUORO-PYRIDIN-3-YL-9H-DIPYRIDO23-B34-DPYRROLE
PRD11158263 · Product
- Active substance
- 2-6-18FFLUORO-PYRIDIN-3-YL-9H-DIPYRIDO23-B34-DPYRROLE
- Substance synonyms
- [18F]RO6958948, [18F]RO-948
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- INTRAVENOUS INJECTION
- Max daily dose
- 370 MBq megabecquerel(s)
- Max total dose
- 370 MBq megabecquerel(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
PRD11158273 · Product
- Active substance
- Florquinitau (18F)
- Substance synonyms
- Florquinitau F18, [18F] MK-6240
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- INTRAVENOUS INJECTION
- Max daily dose
- 185 MBq megabecquerel(s)
- Max total dose
- 185 MBq megabecquerel(s)
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Not Authorised
- MA holder
- INSTITUT DE RECERCA DE L HOSPITAL DE LA SANTA CREU I SANT PAU
- Paediatric formulation
- No
- Orphan designation
- No
PRD8361304 · Product
- Active substance
- Izaflortaucipir (18F)
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- INTRAVENOUS INJECTION
- Max daily dose
- 185 MBq megabecquerel(s)
- Max total dose
- 185 MBq megabecquerel(s)
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Not Authorised
- MA holder
- LIFE MOLECULAR IMAGING GMBH
- Paediatric formulation
- No
- Orphan designation
- No
Auxiliary 1
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 INJECTION
- Max daily dose
- 150 MBq megabecquerel(s)
- Max total dose
- 150 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
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Fundacio Institut De Recerca De L Hospital De La Santa Creu I Sant Pau
- Sponsor organisation
- Fundacio Institut De Recerca De L Hospital De La Santa Creu I Sant Pau
- Address
- Calle De San Quintin 77-79
- City
- Barcelona
- Postcode
- 08041
- Country
- Spain
Scientific contact point
- Organisation
- Fundacio Institut De Recerca De L Hospital De La Santa Creu I Sant Pau
- Contact name
- Alejandra Espinosa
Public contact point
- Organisation
- Fundacio Institut De Recerca De L Hospital De La Santa Creu I Sant Pau
- Contact name
- Alejandra Espinosa
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Spain | Ongoing, recruiting | 150 | 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 | 2024-07-01 | 2024-07-29 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 29 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_Protocol 2023-510508-31-01 | 8 |
| Protocol (for publication) | D1_Protocolo ECM HEAD V3 for pub | 3 |
| Protocol (for publication) | IIBSP-HEA-2022-145_Protocolo_V1_ for publication | 1 |
| Protocol (for publication) | Protocolo ECM HEAD Vs 2 | 1 |
| Protocol (for publication) | Protocolo ECM HEAD Vs 2 for publication | 1 |
| Protocol (for publication) | Protocolo ECM HEAD_V4_CLEAN_for publication | 4 |
| Protocol (for publication) | Protocolo ECM HEAD_V5_CLEAN_FINAL | 5 |
| Protocol (for publication) | Protocolo ECM HEAD_V5_TRACKED_FINAL | 5 |
| Protocol (for publication) | Protocolo ECM HEAD_V6_for pub | 6 |
| Protocol (for publication) | Protocolo ECM HEAD_V7_CLEAN_FOR PUBLICATION | 7 |
| Protocol (for publication) | Protocolo ECM HEAD_V7_TRACKED_FOR PUBLICATION | 7 |
| Recruitment arrangements (for publication) | Procedimientos y material para reclutamiento HEAD FOR PUBLICATION | 1 |
| Subject information and informed consent form (for publication) | 2 HIP CI HEAD - CONTROLES_v3_for publication | 3 |
| Subject information and informed consent form (for publication) | 2 HIP CI HEAD - CONTROLES_v4_CLEAN_for publication | 4 |
| Subject information and informed consent form (for publication) | 2 HIP CI HEAD - DS_v1_CLEAN_FOR PUBLICATION | 1 |
| Subject information and informed consent form (for publication) | 2 HIP CI HEAD - PACIENTES_v3_for publication | 3 |
| Subject information and informed consent form (for publication) | 2 HIP CI HEAD - PACIENTES_v4_CLEAN_for publication | 4 |
| Subject information and informed consent form (for publication) | HIP CI HEAD - CONTROLES FOR PUBLICATION | 1 |
| Subject information and informed consent form (for publication) | HIP CI HEAD - PACIENTES FOR PUBLICATION | 1 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF DS Public | 4 |
| Subject information and informed consent form (for publication) | L1_ SIS DS adapted Public | 2 |
| Subject information and informed consent form (for publication) | L1_HIP CI HEAD CONTROLES v2 PUBL | 2 |
| Subject information and informed consent form (for publication) | L1_HIP CI HEAD PACIENTES v2 PUBL | 2 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis HEADV3 for pub | 3 |
| Synopsis of the protocol (for publication) | English summary Protocolo ECM HEAD_V4_for publication | 4 |
| Synopsis of the protocol (for publication) | English summary Protocolo ECM HEAD_V5_FINAL | 5 |
| Synopsis of the protocol (for publication) | English summary Protocolo ECM HEAD_V6_for pub | 6 |
| Synopsis of the protocol (for publication) | IIBSP-HEA-2022-145_ProtocoloSynopsis_V1_ for publication | 1 |
| Synopsis of the protocol (for publication) | resumen_ Protocolo ECM HEAD_V6_for pub | 6 |
Application history
2 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-03-08 | Spain | Acceptable 2024-06-19
|
2024-06-19 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-09-16 | Spain | Acceptable with conditions 2024-12-03
|
2024-12-03 |