RecruitingNot ApplicableNCT06618872

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

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

Sponsor

University Hospital, Geneva

Enrollment

120 participants

Start Date

Dec 3, 2024

Study Type

INTERVENTIONAL

Conditions

Dementia Alzheimer Disease

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

Min Age: 50 YearsMax Age: 85 Years

Inclusion Criteria6

Written Inform Consent to participating.
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 Criteria6

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