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

Launched by UNIVERSITY HOSPITAL, GENEVA · Sep 27, 2024

Keywords

ClinConnect Summary

This clinical trial is studying the effectiveness of a special imaging technique called tau-PET using a substance called [18F]RO948, compared to another imaging method known as amyloid-PET. Both methods are used to help doctors understand different types of brain changes in patients who have Mild Cognitive Impairment (MCI) or mild dementia, which can be early signs of conditions like Alzheimer’s disease. By comparing these two imaging techniques, researchers hope to find out which one provides more helpful information for diagnosing these conditions.

To participate in this study, individuals need to be between 50 and 85 years old and have a diagnosis of MCI or mild dementia. They must also be able to undergo an MRI scan and have had a recent prescription for an amyloid PET scan. Participants will need to provide written consent to join the study and must be willing to follow the study's requirements. Throughout the trial, participants can expect to undergo imaging tests and assessments to help researchers gather data. It’s important to note that certain health conditions or previous participation in related trials may disqualify individuals from joining, so it's best to discuss eligibility with a healthcare provider.

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ALL

Eligibility 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