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Recruiting NCT06618872

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

Trial Parameters

Condition Dementia
Sponsor University Hospital, Geneva
Study Type INTERVENTIONAL
Phase N/A
Enrollment 120
Sex ALL
Min Age 50 Years
Max Age 85 Years
Start Date 2024-12-03
Completion 2027-08-30
Interventions
PET/CT with RO958 (experimental)

Brief Summary

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

Eligibility Criteria

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

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