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Alzheimer's Disease (AD)NCT07417540

Evaluation of SCALE PET Software for Quantitative Brain PET Analysis in Alzheimer's Disease

A study testing Neurophet SCALE PET in people with Alzheimer's Disease (AD) and Mild Cognitive Impairment (MCI), run by NEUROPHET at 1 site in South Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The goal of this study is to learn if medical image analysis software, Neurophet SCALE PET, can enhance readers' amyloid beta positivity performance in people with Alzheimer's Disease. Read more about this study

Who is it for?
Ages 50 years and older
What is being tested?
Neurophet SCALE PET
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
190 participants
Where
1 siteSouth Korea
Study dates
2 Jun 2025to 17 Nov 2025
Phase
Interventional
Are there results?
None posted in the registry

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 50 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Inclusion Criteria: Medical imaging datasets meeting all of the following criteria will be eligible for inclusion in this study.

  1. Age ≥ 50 years at the time of brain magnetic resonance imaging (MRI)
  2. Participants who underwent amyloid brain PET imaging using one of the following tracers: 18F-Florbetaben, 18F-Florbetapir, 18F-Flutemetamol
  3. Availability of 3D T1-weighted brain MRI.
  4. The interval between amyloid PET and 3D T1-weighted MRI is within 1 year.
  5. Participants meeting one of the following predefined groups based on prior visual interpretation of amyloid PET:
  • Aβ-positive group: Prior clinical interpretation of amyloid PET reported as Aβ positive.
  • Aβ-negative group: Prior clinical interpretation of amyloid PET reported as Aβ negative.

Exclusion Criteria: Medical imaging datasets meeting any of the following criteria will be excluded from the study.

  1. Poor image quality due to artifacts, motion, shading, or other technical issues that make visual interpretation difficult or prevent proper software processing.
  2. Presence of prior brain surgery resulting in significant structural changes, or presence of intracranial metallic implants.
  3. Contrast-enhanced 3D T1-weighted brain MRI.
  4. Presence of structural brain lesions other than cerebral infarction.
  5. Cases deemed inappropriate for study participation at the investigator's discretion.

Trial locations and contacts

1 site in 1 country.

South Korea1 site

  • Ajou University Hospital

    Suwon

Other trials in South Korea

About this study

Official title: A Single-Center, Retrospective, Rater-Blinded, Crossover Study to Evaluate the Efficacy of the Medical Image Analysis Software 'SCALE PET' for Quantitative Analysis of Brain PET Images in Patients With Alzheimer's Disease

The goal of this study is to learn if medical image analysis software, Neurophet SCALE PET, can enhance readers' amyloid beta positivity performance in people with Alzheimer's Disease. The main question it aims to answer is:

Does the use of medical image analysis software assistance result in a statistically significant difference in readers' sensitivity and specificity for the classification of amyloid-β (Aβ) positivity?

Four readers will interpret amyloid PET images in two sessions (with and without software assistance), separated by a 4-week washout period, and will record Aβ positivity and diagnostic confidence using predefined rating scales.

Read the detailed description
  1. Study Overview This study is a single-center, retrospective, rater-blinded, crossover reader study. The primary objective is to evaluate the efficacy of 'Neurophet SCALE PET', a medical image analysis software, in assisting clinicians with the quantitative analysis of amyloid-beta (Aβ) positivity on brain PET scans. The study will compare the performance of readers when they use the software (SW-assisted) versus when they do not use it (unassisted).
  2. Data Collection and Reference Standard The investigators will retrospectively collect medical data from a total of 194 patients (97 Aβ-positive and 97 Aβ-negative cases). Data Sources: De-identified data will be obtained from Ajou University Hospital and the Alzheimer's Disease Neuroimaging Initiative (ADNI) database.
  3. Study Procedures (Reader Study) The reader study consists of two main reading sessions separated by a 4-week washout period to minimize memory bias and order effects. Four readers will be randomly assigned to two groups (Reader Group 1 and Reader Group 2).
  • Session 1: Reader Group 1 will evaluate Case Group A with SW assistance and Case Group B without assistance. Reader Group 2 will evaluate Case Group B with SW assistance and Case Group A without assistance.
  • Washout Period: A 4-week interval will be implemented between sessions.
  • Session 2: The conditions will be swapped following a crossover design. Readers will re-evaluate the same cases under the opposite condition (assisted vs. unassisted) compared to Session 1. During each session, readers will rate Aβ positivity on a 5-point scale (1: Definitely negative, 2: Probably negative, 3: Equivocal, 4: Probably positive, 5: Definitely positive) and record their diagnostic confidence level on a 3-point scale (1: low confidence, 2: moderate confidence, 3: high confidence).
  1. Statistical Analysis The efficacy of the software will be assessed by comparing the diagnostic performance between the SW-assisted and unassisted conditions.
  • Primary outcomes: Differences in readers' sensitivity and specificity for Aβ positivity classification.
  • Secondary Outcomes: Differences in diagnostic accuracy (AUC), the number of cases rated as "equivocal," rater confidence levels, and inter-rater agreement.
Being tested
Neurophet SCALE PET
Keywords
Alzheimer's Disease, Amyloid-β (Aβ), brain PET, quantification, AI software, reader study, Multi-Reader Multi-Case (MRMC), Centiloid Scale, SUVR
Medical subject headings
Alzheimer Disease, Cognitive Dysfunction

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Neurophet SCALE PETDevice

    Neurophet SCALE PET is an artificial intelligence-based medical image analysis software designed for the quantitative analysis of brain PET images. It provides automated quantification of amyloid-beta (Aβ) deposition using standardized uptake value ratios (SUVR) and the Centiloid scale. In this study, the software is used as a diagnostic support tool to assist clinicians in evaluating Aβ positivity.

Study groups in NCT07417540
Study groupRoleWhat they receive
Reader group 1ExperimentalIn Session 1, readers in this group interpret Case Group A with software (SW) assistance and Case Group B without assistance (visual read). Following a 4-week washout period, the conditions are swapped for Session 2: readers interpret Case Group A without SW assistance and Case Group B with SW assistance.
Receives: Device: Neurophet SCALE PET
Reader group 2ExperimentalIn Session 1, readers in this group interpret Case Group B with software (SW) assistance and Case Group A without assistance (visual read). Following a 4-week washout period, the conditions are swapped for Session 2: readers interpret Case Group B without SW assistance and Case Group A with SW assistance.
Receives: Device: Neurophet SCALE PET

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Difference in readers' sensitivity in SW-assisted vs. unassisted classification of Aβ positivity

    Comparison of the sensitivity for amyloid-beta positivity between the software-assisted and unassisted reading conditions, based on the expert-established reference standard.

    Measured: At the completion of two reading sessions (approximately 3 months)

  2. Difference in readers' specificity in SW-assisted vs. unassisted classification of Aβ positivity

    Comparison of the specificity for amyloid-beta negativity between the software-assisted and unassisted reading conditions, based on the expert-established reference standard.

    Measured: At the completion of the reading study (approximately 3 months)

Secondary outcomes (4)

  1. Difference in readers' diagnostic accuracy in SW-assisted vs. unassisted classification of Aβ positivity

    The difference in diagnostic accuracy is evaluated using the Area Under the Receiver Operating Characteristic (ROC) Curve (AUC).

    Measured: At the completion of the reading study (approximately 3 months)

  2. Difference in number of cases rated as equivocal in SW-assisted vs. unassisted classification of Aβ positivity

    Comparison of the frequency of cases rated as "3: Equivocal" on the 5-point scale between the software-assisted and unassisted conditions.

    Measured: At the completion of the reading study (approximately 3 months)

  3. Difference in confidence level of readers in SW-assisted vs. unassisted classification of Aβ positivity

    Comparison of the readers' self-reported confidence levels when making a diagnosis

    Measured: At the completion of the reading study (approximately 3 months)

  4. Inter-rater Agreement

    Evaluation of the consistency in amyloid-beta positivity ratings among the four readers

    Measured: At the completion of the reading study (approximately 3 months)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Feb 2026
  2. Study start2 Jun 2025
  3. Primary completion17 Nov 2025
  4. Study completion17 Nov 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Diagnosis
Allocation
Randomised
Intervention model
Crossover
Masking
Single blind
Who is masked
Investigator
Enrolment
190 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07417540
Sponsor's protocol ID
AJOUIRB-DE-2025-195
Status last verified
Feb 2026
First submitted
11 Feb 2026
Last updated
18 Feb 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Neurophet SCALE PET in people with Alzheimer's Disease (AD) and Mild Cognitive Impairment (MCI), run by NEUROPHET at 1 site in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

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 18 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in South Korea. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Difference in readers' sensitivity in SW-assisted vs. unassisted classification of Aβ positivity (time frame: At the completion of two reading sessions (approximately 3 months)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07417540.

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 18 Feb 2026.

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