Cognitive ImpairmentNCT04773015
A Study to Evaluate the Effectiveness of VIZAMYL™ Reader Training Programme in Europe
An observational study of Cognitive Impairment, run by GE Healthcare at 10 sites in 5 countries.
Trial summary
This is a study to determine the effectiveness of the VIZAMYL™ reader training programme in clinical practice in Europe Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cognitive Impairment
- How many people
- 227 participants
- Where
- 10 sitesin 5 countries
- Study dates
- 11 Dec 2018to 7 Dec 2021
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: tertiary referral
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
10 sites in 5 countries.
10 sites in 5 countries
Italy3 sites
Ospedal Mons Dimicolli - Barletta
Barletta, 70051
U.O. Medicina Nucleare- ASSST Spedali Civili P.O. di Brescia
Brescia, 25123
Azienda Ospedaliero Universitaria Careggi - S.O.D. Patologia Medica
Florence, 50134
Spain3 sites
Vall d'Hebron University Hospital
Barcelona, 08035
Hospital Universitari de Bellvitge
Barcelona, 08907
Clinica Universidad de Navarra
Pamplona, 31008
Austria2 sites
Kepler Universittsklinikum Neuromed Campus
Linz, Wagner-Jauregg-Weg, 4020
Landeskrankenhaus Vocklabruck
Vöcklabruck, 4840
About this study
Official title: A Post-Authorisation Safety Study to Evaluate the Effectiveness of VIZAMYL™ Reader Training in Europe
This is a study to determine the effectiveness of the VIZAMYL™ reader training programme in clinical practice in Europe
Read the detailed description
This study is a combination of Prospective and Retrospective models.
- Conditions
- Cognitive Impairment
- Keywords
- Vizamyl, flutemetamol, Alzheimer's disease, cognitive impairment, dementia
- Medical subject headings
- Cognitive Dysfunction, Alzheimer Disease, Dementia
What is being measured
The primary outcome is the main question the study is designed to answer.
Accuracy of VIZAMYL™ PET Image Interpretations Made by Clinical Readers
Accuracy was estimated as 100 percent (%) *(number of true positives [TP] + number of true negatives [TN]) / (number of TP + number of TN + number of false positives [FP] + number of false negatives [FN]). The data presented are the point estimates representing percentage of accuracy, with Measure Type "Number" and 95% exact binomial confidence interval. These have been estimated using Clopper-Pearson method.
Measured: Up to 1093 days
Sensitivity of VIZAMYL™ PET Image Interpretations Made by Clinical Readers
Sensitivity was defined as 100%*number of TP / (number of TP + number of FN). The data presented are the point estimates representing percentage sensitivity, with Measure Type "Number" and 95% exact binomial confidence interval. These have been estimated using Clopper-Pearson method.
Measured: Up to 1093 days
Specificity of VIZAMYL™ PET Image Interpretations Made by Clinical Readers
Specificity was defined as 100%*number of TN / (number of TN + number of FP). The data presented are the point estimates representing the percentage specificity, with Measure Type "Number" and 95% exact binomial confidence interval. These have been estimated using Clopper-Pearson method.
Measured: Up to 1093 days
Positive Predictive Value (PPV) of VIZAMYL™ PET Image Interpretations Made by Clinical Readers
The PPV was defined as 100%*number of TP / (number of TP + number of FP). The data presented are the point estimates representing percentage PPV, with Measure Type "Number" and 95% exact binomial confidence interval. These have been estimated using Clopper-Pearson method.
Measured: Up to 1093 days
Negative Predictive Value (NPV) of VIZAMYL™ PET Image Interpretations Made by Clinical Readers
The NPV was defined as 100%*number of TN/ (number of TN + number of FN). The data presented are the point estimates representing percentage NPV, with Measure Type "Number" and 95% exact binomial confidence interval. These have been estimated using Clopper-Pearson method.
Measured: Up to 1093 days
Secondary outcomes (6)
Correlation Coefficient Between Clinical Reader Age and Accuracy
Correlation coefficient was used to assess the correlation between clinical reader age and accuracy. A scatterplot of clinical reader accuracy vs. reader age was plotted to check correlation (coefficient) between accuracy and age.
Measured: Up to 1093 days
Number of Participants With Accuracy Less Than (<) 0.9333 or Greater Than Equal to (>=) 0.9333 in Terms of Sex of Clinical Readers
Number of participants with accuracy < 0.9333 or >= 0.9333 in terms of sex of clinical readers were reported.
Measured: Up to 1093 days
Number of Participants With Association of Electronic Training (With or Without In-Person Training) With Clinical Reader Accuracy
Number of participants with association of electronic training (with or without In-person training) with clinical reader accuracy were reported.
Measured: Up to 1093 days
Number of Participants With Association of In-Person Training (With or Without Electronic Training) With Clinical Reader Accuracy
Number of participants with association of In-person training (with or without electronic training) with clinical reader accuracy were reported.
Measured: Up to 1093 days
Number of Participants With Association of Training Type With Clinical Reader Accuracy (Excluding Readers Who Took Both Types)
Number of participants with association of training type with clinical reader accuracy (excluding readers who took both types) were reported.
Measured: Up to 1093 days
Time From Last Training
Time from last training was reported. Number of readers remaining at timepoint was number of readers with accuracy greater than or equal to 0.9333. All readers met this criterion at time 0 hence, data for all clinical reader is reported. All 18 readers were trained in interpretation of Vizamyl images \& as part of their training, had their interpretation accuracy tested using 15 test images. To pass test, a reader had to interpret atleast 14 of 15 images correctly. 14 represents 0.9333 of 15, so each reader had to have an accuracy of atleast 0.9333 in order to pass test. Date on which a reader took his/her test is considered to be Time 0. Each reader's accuracy at a later time was assessed in study.
Measured: Retrospective data covering up to 8.1 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2021
- Study start11 Dec 2018
- Primary completion7 Dec 2021
- Study completion7 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Cognitive ImpairmentStudies of the same condition, open and under way.
- More trials run by GE HealthcareThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 227 participants (actual)
Sponsor and investigators
- Lead sponsor
- GE Healthcare
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- ICON plc
- Responsible party
- Sponsor
- Investigators
- Paul Sherwin, MD, PhD, Study director, GE Healthcare
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04773015
- Sponsor's protocol ID
- GE-067-027
- Status last verified
- Oct 2024
- First submitted
- 23 Feb 2021
- Last updated
- 10 Oct 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Post-Authorisation Safety Study to Evaluate the Effectiveness of VIZAMYL™ Reader Training in Europe
- ClinicalTrials.gov ID
- NCT04773015
- Acronym / sponsor ID
- GE-067-027
- Conditions
- Cognitive Impairment
- Keywords
- Vizamyl, flutemetamol, Alzheimer's disease, cognitive impairment, dementia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 227 participants (actual)
- Lead sponsor
- GE HealthcareIndustry (pharma, biotech, devices)
- Collaborators
- ICON plc
- Study start
- 11 Dec 2018 (actual)
- Primary completion
- 7 Dec 2021 (actual)
- Study completion
- 7 Dec 2021 (actual)
- First posted
- 26 Feb 2021 (actual)
- Results
- Posted 10 Oct 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a study to determine the effectiveness of the VIZAMYL™ reader training programme in clinical practice in Europe
Detailed description
This study is a combination of Prospective and Retrospective models.
Study design
- Observational model
- Cohort
- Time perspective
- Other
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- tertiary referral
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Accuracy of VIZAMYL™ PET Image Interpretations Made by Clinical Readers
Time frame: Up to 1093 days
Accuracy was estimated as 100 percent (%) *(number of true positives [TP] + number of true negatives [TN]) / (number of TP + number of TN + number of false positives [FP] + number of false negatives [FN]). The data presented are the point estimates representing percentage of accuracy, with Measure Type "Number" and 95% exact binomial confidence interval. These have been estimated using Clopper-Pearson method.
Sensitivity of VIZAMYL™ PET Image Interpretations Made by Clinical Readers
Time frame: Up to 1093 days
Sensitivity was defined as 100%*number of TP / (number of TP + number of FN). The data presented are the point estimates representing percentage sensitivity, with Measure Type "Number" and 95% exact binomial confidence interval. These have been estimated using Clopper-Pearson method.
Specificity of VIZAMYL™ PET Image Interpretations Made by Clinical Readers
Time frame: Up to 1093 days
Specificity was defined as 100%*number of TN / (number of TN + number of FP). The data presented are the point estimates representing the percentage specificity, with Measure Type "Number" and 95% exact binomial confidence interval. These have been estimated using Clopper-Pearson method.
Positive Predictive Value (PPV) of VIZAMYL™ PET Image Interpretations Made by Clinical Readers
Time frame: Up to 1093 days
The PPV was defined as 100%*number of TP / (number of TP + number of FP). The data presented are the point estimates representing percentage PPV, with Measure Type "Number" and 95% exact binomial confidence interval. These have been estimated using Clopper-Pearson method.
Negative Predictive Value (NPV) of VIZAMYL™ PET Image Interpretations Made by Clinical Readers
Time frame: Up to 1093 days
The NPV was defined as 100%*number of TN/ (number of TN + number of FN). The data presented are the point estimates representing percentage NPV, with Measure Type "Number" and 95% exact binomial confidence interval. These have been estimated using Clopper-Pearson method.
6 secondary outcomes
Correlation Coefficient Between Clinical Reader Age and Accuracy
Time frame: Up to 1093 days
Number of Participants With Accuracy Less Than (<) 0.9333 or Greater Than Equal to (>=) 0.9333 in Terms of Sex of Clinical Readers
Time frame: Up to 1093 days
Number of Participants With Association of Electronic Training (With or Without In-Person Training) With Clinical Reader Accuracy
Time frame: Up to 1093 days
Number of Participants With Association of In-Person Training (With or Without Electronic Training) With Clinical Reader Accuracy
Time frame: Up to 1093 days
Number of Participants With Association of Training Type With Clinical Reader Accuracy (Excluding Readers Who Took Both Types)
Time frame: Up to 1093 days
Time From Last Training
Time frame: Retrospective data covering up to 8.1 years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Oct 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Paul Sherwin, MD, PhD study director
GE Healthcare
10 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cognitive Impairment, run by GE Healthcare at 10 sites in 5 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in Italy, Spain, Austria, Finland, Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 10 Oct 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Accuracy of VIZAMYL™ PET Image Interpretations Made by Clinical Readers (time frame: Up to 1093 days). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Oct 2024.