Comparing tau-PET and amyloid-PET for diagnosing cognitive impairment
Incremental Diagnostic Value of Tau-PET With [18F]RO948 vs Amyloid-PET in Patients With
This study is testing whether a new type of brain scan called tau-PET can help doctors better diagnose Alzheimer's disease in people with mild cognitive impairment or mild dementia compared to the standard amyloid-PET scan.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 120 (estimated) |
| Ages | 50 Years to 85 Years |
| Sex | All |
| Sponsor | University Hospital, Geneva Academic / other |
| Locations | 2 sites (Geneva, Canton of Geneva and 1 other locations) |
| Trial ID | NCT06618872 on ClinicalTrials.gov |
What this trial studies
This study investigates the clinical validity of tau-PET using [18F]RO948 compared to amyloid-PET in patients with Mild Cognitive Impairment (MCI) or mild dementia. It aims to assess the diagnostic utility of these imaging techniques to improve early and differential diagnosis of Alzheimer's disease. The study will provide unique insights into the effectiveness of tau-PET, which has not been prospectively evaluated before, thereby potentially influencing clinical practice and diagnostic algorithms for dementia. Participants will undergo PET/CT scans to evaluate the presence of tau and amyloid pathology.
Who should consider this trial
Good fit: Ideal candidates are individuals aged 50 to 85 diagnosed with Mild Cognitive Impairment or mild dementia.
Not a fit: Patients with psychiatric disorders, significant vascular dementia, or those enrolled in conflicting clinical trials may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance diagnostic accuracy for Alzheimer's disease, leading to better-targeted treatments for patients.
How similar studies have performed: While amyloid-PET has been extensively studied, this is the first prospective evaluation of tau-PET, making it a novel approach.
Eligibility criteria
Show full inclusion / exclusion 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 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
Where this trial is running
Geneva, Canton of Geneva and 1 other locations
- Geneva University Hospital — Geneva, Canton of Geneva, Switzerland (Recruiting)
- Centre Medical Universitaire Vaudois — Lausanne, Canton of Vaud, Switzerland (Recruiting)
Study contacts
- Study coordinator: Valentina Garibotto, MD
- Email: valentina.garibotto@hug.ch
- Phone: +41223727252
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.