Clinical trial • Phase IV • Neurology|Other
FLORQUINITAU (18F) for Cognitive impairment|Mild cognitive impairment|Alzheimer's disease|Frontotemporal dementia|Primary progressive aphasia|Progressive supranuclear palsy|Corticobasal degeneration|Dementia with Lewy bodies|Down syndrome
Phase IV trial of FLORQUINITAU (18F) for Cognitive impairment|Mild cognitive impairment|Alzheimer's disease|Frontotemporal dementia|Primary progressive ap…
Overview
- Trial Therapeutic Area
- Neurology|Other
- Trial Disease
- Cognitive impairment|Mild cognitive impairment|Alzheimer's disease|Frontotemporal dementia|Primary progressive aphasia|Progressive supranuclear palsy|Corticobasal degeneration|Dementia with Lewy bodies|Down syndrome
- Trial Stage
- Phase IV
- Drug Modality
- Radiopharmaceutical
Key dates
- Initial CTIS Submission Date
- 08-03-2024
- First CTIS Authorization Date
- 19-06-2024
Trial design
None/Not specified-controlled Phase IV trial across 1 site in Spain.
- Comparator
- None/Not specified
- Target Sample Size
- 150
- Trial Duration For Participant
- 540-720
Eligibility
Recruits 150 Vulnerable population selected: Down's Syndrome participants. Specific subject information and informed consent forms for Down's Syndrome are provided (documents listed: '2 HIP CI HEAD - DS_v1_CLEAN_FOR PUBLICATION', 'L1_ SIS and ICF DS Public', 'L1_ SIS DS adapted Public')..
- Vulnerable Population
- Vulnerable population selected: Down's Syndrome participants. Specific subject information and informed consent forms for Down's Syndrome are provided (documents listed: '2 HIP CI HEAD - DS_v1_CLEAN_FOR PUBLICATION', 'L1_ SIS and ICF DS Public', 'L1_ SIS DS adapted Public').
Inclusion criteria
- {"criterion_text":"- For Healthy Cognitive Controls: Age: > 18 years (minimum N=5 young individuals aged between 18 and 28) Clinical Criterion: CDR = 0\n- Mild Cognitive Impairment (MCI): Age: 50-90 years (inclusive) Clinical Criteria: NIA-AA 2018, MMSE (22-28)\n- Alzheimer's Disease (AD): Age: 50-90 years (inclusive) Clinical Criteria: NIA-AA 2018, MMSE (11-24)\n- Frontotemporal Dementia: Age: 50-90 years (inclusive) Clinical Criteria: Rascovsky et al., 2011\n- Primary Progressive Aphasia: Age: 50-90 years (inclusive) Clinical Criteria: Gorno-Tempini et al., 2011\n- Progressive Supranuclear Palsy: Age: 50-90 years (inclusive) Clinical Criteria: Hoglinger et al., 2017\n- Corticobasal Degeneration: Age: 50-90 years (inclusive) Clinical Criteria: Armstrong et al., 2013\n- Dementia with Lewy Bodies: Age: 50-90 years (inclusive) Clinical Criteria: McKeith et al., 2017\n- Down's Syndrome (SD): Age: > 18 years"}
Exclusion criteria
- {"criterion_text":"- Patient with out inclusion criteria"}
Endpoints
Primary endpoints
- {"endpoint_text":"- 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","definition_or_measurement_approach":"SUVR measured from tau PET images co-registered with structural MRI using the lower cerebellar cortex as reference region"}
Secondary endpoints
- {"endpoint_text":"- SUVR values obtained for different tracers.","definition_or_measurement_approach":""}
- {"endpoint_text":"- Voxel-wise and regional correlation analysis.","definition_or_measurement_approach":""}
- {"endpoint_text":"- Transformed values to standardize tau PET tracers to a common scale.","definition_or_measurement_approach":""}
- {"endpoint_text":"- Diagnostic performance among different groups.","definition_or_measurement_approach":""}
- {"endpoint_text":"- Associations of tau tracers with amyloid.","definition_or_measurement_approach":""}
- {"endpoint_text":"- Associations of tau tracers with brain atrophy.","definition_or_measurement_approach":""}
- {"endpoint_text":"- Associations of tau tracers with cognition.","definition_or_measurement_approach":""}
- {"endpoint_text":"- Associations of tau tracers with plasma tau biomarkers (p-tau181, p-tau-217, and p-tau231).","definition_or_measurement_approach":""}
- {"endpoint_text":"- Longitudinal tau accumulation rates among tracers.","definition_or_measurement_approach":""}
- {"endpoint_text":"- Associations between longitudinal changes in tau and amyloid deposition.","definition_or_measurement_approach":""}
- {"endpoint_text":"- Associations between longitudinal changes in tau and brain atrophy.","definition_or_measurement_approach":""}
- {"endpoint_text":"- Associations between longitudinal changes in tau and progression in cognition.","definition_or_measurement_approach":""}
Recruitment
- Planned Sample Size
- 150
- Recruitment Window Months
- 34
- Consent Approach
- Informed consent obtained using subject information and informed consent forms for patients and controls (multiple versions listed). Specific adapted information and consent forms are provided for Down's Syndrome participants (documents: '2 HIP CI HEAD - DS_v1_CLEAN_FOR PUBLICATION', 'L1_ SIS and ICF DS Public', 'L1_ SIS DS adapted Public'). English summaries of the protocol are available. Consent is provided by participants; adapted forms are provided for vulnerable participants.
Geography
- Total Number Of Sites
- 1
- Total Number Of Participants
- 150
Spain
- Earliest CTIS Part Ii Submission Date
- 24-05-2024
- Latest Decision Or Authorization Date
- 03-12-2024
- Processing Time Days
- 193
- Number Of Sites
- 1
- Number Of Participants
- 150
Sites
- Site Name
- Hospital De La Santa Creu I Sant Pau
- Department Name
- Neurology
- Principal Investigator Name
- Juan Fortea Ormaechea
- Principal Investigator Email
- jfortea@santpau.cat
- Contact Person Name
- Juan Fortea Ormaechea
- Contact Person Email
- jfortea@santpau.cat
Sponsor
Primary sponsor
- Full Name
- Fundacio Institut De Recerca De L Hospital De La Santa Creu I Sant Pau
- Organisation Type
- Hospital/Clinic/Other health care facility
- Country Of Registered Address
- Spain
Investigational products
- Investigational Product Name
- florquinitau F-18
- Active Substance
- FLORQUINITAU (18F)
- Modality
- Radiopharmaceutical
- Routes Of Administration
- INTRAVENOUS INJECTION
- Route
- INTRAVENOUS INJECTION
- Authorisation Status
- Investigational (no marketing authorisation recorded)
- Dose Levels
- Max daily dose: 185 MBq; Max total dose: 185 MBq
- Frequency
- Single administration (maxTreatmentPeriod=1)
- Maximum Dose
- 185 MBq
- Investigational Product Name
- [18F]RO6958948
- Active Substance
- 2-(6-[18F]FLUORO-PYRIDIN-3-YL)-9H-DIPYRIDO[2,3-B:3',4'-D]PYRROLE
- Modality
- Radiopharmaceutical
- Routes Of Administration
- INTRAVENOUS INJECTION
- Route
- INTRAVENOUS INJECTION
- Authorisation Status
- Investigational (no marketing authorisation recorded)
- Dose Levels
- Max daily dose: 370 MBq; Max total dose: 370 MBq
- Frequency
- Single administration (maxTreatmentPeriod=1)
- Maximum Dose
- 370 MBq
- Investigational Product Name
- VIZAMYL 400 MBq/mL solution for injection
- Active Substance
- FLUTEMETAMOL (18F)
- Modality
- Radiopharmaceutical
- Routes Of Administration
- INTRAVENOUS INJECTION
- Route
- INTRAVENOUS INJECTION
- Authorisation Status
- Authorised (EU/1/14/941/001)
- Dose Levels
- Max daily dose: 150 MBq; Max total dose: 150 MBq
- Frequency
- Single administration (maxTreatmentPeriod=1)
- Maximum Dose
- 150 MBq
- Investigational Product Name
- [18F]PI-2620
- Active Substance
- IZAFLORTAUCIPIR (18F)
- Modality
- Radiopharmaceutical
- Routes Of Administration
- INTRAVENOUS INJECTION
- Route
- INTRAVENOUS INJECTION
- Authorisation Status
- Investigational (no marketing authorisation recorded)
- Dose Levels
- Max daily dose: 185 MBq; Max total dose: 185 MBq
- Frequency
- Single administration (maxTreatmentPeriod=1)
- Maximum Dose
- 185 MBq
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