Ignite Creation Date:
2024-10-26 @ 3:41 PM
Last Modification Date:
2024-10-26 @ 3:41 PM
Study NCT ID:
NCT06618872
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-27
Brief Title:
Incremental Diagnostic Value of Tau-PET With 18FRO948 vs Amyloid-PET in Patients With Cognitive Impairment
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Incremental Diagnostic Value of Tau-PET With 18FRO948 vs Amyloid-PET in Patients With
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
IDV of tau-PET
Brief Summary:
The objective of the study is to investigate the clinical validity of tau-PET with 18FRO948 vs amyloid-PET in patients with Mild Cognitive Impairment MCI or mild dementia
Detailed Description:
Dementia is defined as cognitive impairment associated with loss of autonomy and is usually preceded by a prodromal phase - Mild Cognitive Impairment MCI - which represents a highly heterogeneous entity comprising different underlying etiologies of which Alzheimers disease AD is one of the most prevalent Several AD biomarkers - including MRI FDG-PET and CSF measures of amyloid and tau pathology - have been validated as diagnostic allowing an early and differential diagnosis of AD and prognostic predicting progression from MCI to dementia due to AD tools In contrast and despite the increasing consensus on their clinical utility usage of PET markers of amyloid and tau pathology is not yet standard clinical practice Moreover while the clinical utility of amyloid-PET has been exhaustively investigated to date no study has prospectively assessed the clinical utility of tau-PET Assessing the clinical utility of diagnostic tools is fundamental for clinical practice This will be the first study assessing the clinical utility of 18FRO948 tau-PET vs standard of care amyloid-PET providing unique information to define appropriate diagnostic algorithms
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None