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

NCT ID: NCT06618872

Last Updated: 2025-12-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-12-03

Study Completion Date

2027-08-30

Brief Summary

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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

Detailed Description

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Dementia is defined as cognitive impairment associated with loss of autonomy and is usually preceded by a prodromal phase - Mild Cognitive Impairment (MCI) - which represents a highly heterogeneous entity comprising different underlying etiologies, of which Alzheimer's disease (AD) is one of the most prevalent. Several AD biomarkers - including MRI, FDG-PET and CSF measures of amyloid and tau pathology - have been validated as diagnostic (allowing an early and differential diagnosis of AD) and prognostic (predicting progression from MCI to dementia due to AD) tools. In contrast and despite the increasing consensus on their clinical utility, usage of PET markers of amyloid and tau pathology is not yet standard clinical practice. Moreover, while the clinical utility of amyloid-PET has been exhaustively investigated, to date no study has prospectively assessed the clinical utility of tau-PET. Assessing the clinical utility of diagnostic tools is fundamental for clinical practice. This will be the first study assessing the clinical utility of \[18F\]RO948 tau-PET vs. standard of care amyloid-PET, providing unique information to define appropriate diagnostic algorithms

Conditions

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Dementia Alzheimer Disease

Keywords

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Alzheimer PET Amyloid Tau

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Participants will have first a Tau-PET (experimental) and then an amyloid PET (standard of care) or the opposite
Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Amyloid-PET and then Tau-PET

The participant will have the Amyloid-PET (standard of care) and then Tau-PET (experimental)

Group Type EXPERIMENTAL

PET/CT with RO958 (experimental)

Intervention Type DIAGNOSTIC_TEST

the participant will have 2 PET (one with an experimental radiotracer- Tau PET), one with a standard radiotracer (amyloid-PET)

Tau-PET and then Amyloid-PET

The participant will have the Tau-PET (experimental) and then the Amyloid-PET (standard of care)

Group Type EXPERIMENTAL

PET/CT with RO958 (experimental)

Intervention Type DIAGNOSTIC_TEST

the participant will have 2 PET (one with an experimental radiotracer- Tau PET), one with a standard radiotracer (amyloid-PET)

Interventions

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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)

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Minimum Eligible Age

50 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centre Hospitalier Universitaire Vaudois

OTHER

Sponsor Role collaborator

University Hospital, Geneva

OTHER

Sponsor Role lead

Responsible Party

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Valentina Garibotto

Head of Nuclear Medecine and molecular imaging

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Geneva University Hospital

Geneva, Canton of Geneva, Switzerland

Site Status RECRUITING

Centre Medical Universitaire Vaudois

Lausanne, Canton of Vaud, Switzerland

Site Status RECRUITING

Countries

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Switzerland

Central Contacts

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Valentina Garibotto, MD

Role: CONTACT

Phone: +41223727252

Email: [email protected]

Facility Contacts

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Valentina Garibotto, Pr

Role: primary

Gilles Allali, MD

Role: primary

Other Identifiers

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2023-02263

Identifier Type: -

Identifier Source: org_study_id