Amyloid PET in Patients With Mild Cognitive Impairment and Early Dementia

NCT06402370 | Recruiting

• 1 other identifier: ONZ-2023-0444
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

The National Institute on Aging together with the Alzheimer's Association (NIA-AA) recently proposed the ATN classification which is based upon the pathological processes present in Alzheimer's disease (amyloid, tau and neurodegeneration). The amyloid and tau status can be defined using cerebrospinal fluid analysis but also non-invasively using an amyloid or tau PET scan. The N status can be defined using an \[18F\]-FDG PET scan which is in Belgium part of standard of care. Recently, it has been demonstrated, using different amyloid PET tracers, that early-frame amyloid scans can be a surrogate for \[18F\]-FDG PET scan.

Conditions

MCI

Outcome Measures

Primary Outcomes (2)

• N-status

  N-status can be determined using ultrashort early frame amyloid scans of 1 minute

  2 years

• A-status

  A-status can be determined with a one minute scan 60-90 minutes after injection

  2 years

Interventions

PET scan DIAGNOSTIC_TEST

\[18F\]Vizamyl

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with early Alzheimer and mild cognitive impairment

You may qualify if:

• Patients with mild cognitive impairment or early stage dementia who have a MRI and \[18F\]FDG PET/CT scan as part of routine clinical work-up

You may not qualify if:

• Patient is not able to understand the study Patient is not able to lie still in the scanner for at least 30 minutes Pregnancy or breastfeeding

Sponsors & Collaborators

• University Hospital, Ghent: lead

Study Sites (1)

Van Weehaeghe D

Ghent, 9000, Belgium

RECRUITING

MeSH Terms

Interventions

Positron-Emission Tomography

Intervention Hierarchy (Ancestors)

Tomography, Emission-Computed; Image Interpretation, Computer-Assisted; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Image Enhancement; Photography; Radionuclide Imaging; Tomography; Diagnostic Techniques, Radioisotope

Study Officials

• Donatienne Van Weehaeghe, MD PhD

  UZ Gent

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Van Weehaeghe Donatienne

CONTACT

+32 9 332 30 27; donatienne.vanweehaeghe@uzgent.be

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 2, 2024
• First Posted: May 7, 2024
• Study Start: May 8, 2024
• Primary Completion: May 1, 2026
• Study Completion: May 1, 2026
• Last Updated: May 20, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)