PET/CT with RO958 (experimental): the participant will have 2 PET (one with an experimental radiotracer- Tau PET), one with a standard radiotracer (amyloid-PET)
Study 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
Sex
ALL
Min age
50 Years
Max age
85 Years
Healthy volunteers
No
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
Primary outcome measure(s)
Difference between tau-PET with [18F]RO948 and amyloid PET in the change of physician's diagnostic confidence (50-100% visual analogue scale) across time — through study completion , an average of 2 years Amyloid and tau PET scans will be classified as positive or negative for the presence of pathology using visual reading by an expert reader (amyloid-PET), as clinically established, and SUVR cut offs previously published for \[18F\]RO948 tau-PET (Leuzy, Smith et al. 2020) as well as a visual check
Difference between tau-PET with [18F]RO948 and amyloid PET in the changes in etiological diagnoses across time (i.e., from Alzheimer disease (AD) to non-AD, or from non-AD to AD). — through study completion , an average of 2 years The changes in etiological diagnosis across rounds will be assessed using the McNemar's test
Trial sites (2)
Facility
City
Region
Status
Geneva University Hospital
Geneva
Canton of Geneva
Recruiting
Centre Medical Universitaire Vaudois
Lausanne
Canton of Vaud
Recruiting
More University Hospital, Geneva trials in Switzerland
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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