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

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

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

Conditions3

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