A Study to Evaluate the Effectiveness of VIZAMYL™ Reader Training Programme in Europe

General Electric (GE)

Status: Completed

Conditions: Cognitive Impairment

Study type: Observational

Funder types: Industry

Identifiers

NCT04773015

GE-067-027

Details and patient eligibility

About

This is a study to determine the effectiveness of the VIZAMYL™ reader training programme in clinical practice in Europe

Full description

This study is a combination of Prospective and Retrospective models.

Enrollment: 227 patients

Sex: All

Ages: 18 to 99 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• The subject is an adult (aged 18 years or older) of any race or gender and has been referred for a VIZAMYL™ PET brain scan as part of the assessment of his/her cognitive impairment.
• The VIZAMYL™ scan was ordered as part of the clinical care of the subject and is not exclusively for a clinical trial.
• If informed consent is required by the local IEC, the subject, or his/her legally authorised representative, is willing and able to sign consent for use of their de-identified VIZAMYL™ PET images and associated anatomic images (brain CT and/or MRI) used in the interpretation of the VIZAMYL™ images as well as de-identified demographic information.

Exclusion criteria

• If informed consent is required by the local IEC, the subject (or representative) is not willing to consent to their de-identified images and other data being used in this study.

Trial design