Comparing tau-PET and amyloid-PET for diagnosing cognitive impairment

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.