Incremental Diagnostic Value of Tau-PET With [18F]RO948 vs Amyloid-PET in Patients With Cognitive Impairment (IDV of tau-PET)

University Hospitals (UH)

Status: Enrolling

Conditions: Alzheimer Disease; Dementia

Treatments: Diagnostic Test: PET/CT with RO958 (experimental)

Study type: Interventional

Funder types: Other

Identifiers

NCT06618872

2023-02263

Details and patient eligibility

About

The objective of the study is to investigate the clinical validity of tau-PET with [18F]RO948 vs. amyloid-PET in patients with Mild Cognitive Impairment (MCI) or mild dementia

Full 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 Alzheimer's 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 [18F]RO948 tau-PET vs. standard of care amyloid-PET, providing unique information to define appropriate diagnostic algorithms

Enrollment: 120 estimated patients

Sex: All

Ages: 50 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Written Inform Consent to participating.
• 50 to 85 years of age
• a diagnosis of Mild Cognitive Impairment (MCI=at least one pathological neuropsychological test but no functional impairment based on the Amsterdam IADL score) or mild dementia (both cognitive and functional impairments)
• availability of MRI within 6 months before screening
• prescription of a diagnostic amyloid PET
• Willing and able to comply with the requirements of the study, as judged by the investigator.

Exclusion criteria

• The presence of psychiatric disorders, extensive white matter lesions or other stigmata of vascular dementia.
• Visual and auditory acuity inadequate for neuropsychological testing.
• Enrolment in previous clinical trials for AD potentially affecting amyloid and/or tau brain load
• Enrolment in other trials or studies not compatible with [18F]RO948 Imaging study.
• Ferromagnetic implants and devices (including implants or devices held in place by sutures, granulation or ingrowth of tissue, fixation devices, or by other means) not eligible for MRI scanning.
• Women of childbearing potential must not be pregnant (negative urine β-hCG on the day of imaging) or breast feeding at screening

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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120 participants in 2 patient groups

Amyloid-PET and then Tau-PET

Experimental group

Description:

The participant will have the Amyloid-PET (standard of care) and then Tau-PET (experimental)

Treatment:

Diagnostic Test: PET/CT with RO958 (experimental)

Tau-PET and then Amyloid-PET

Experimental group

Description:

The participant will have the Tau-PET (experimental) and then the Amyloid-PET (standard of care)

Treatment:

Diagnostic Test: PET/CT with RO958 (experimental)