NCT06618872 · RECRUITING
Incremental Diagnostic Value of Tau-PET With [18F]RO948 vs Amyloid-PET in Patients With Cognitive Impairment
This trial is comparing two types of brain scans in people with Mild Cognitive Impairment or mild dementia. One scan looks for amyloid plaques, the other looks for tau tangles using a radioactive tracer called RO948. Researchers want to know which scan gives doctors more useful diagnostic information. This is a Phase NA diagnostic study, meaning it is evaluating a tool, not testing a treatment.
You may qualify if
- 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.
You're excluded if
- 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
The sponsor's own eligibility wording, lightly reformatted. The study team makes the final eligibility decision — worth discussing with your doctor.
Eligibility criteria as of 2025-12-23