The use of AI in imaging for Alzheimer’s Disease

The use of AI in imaging for Alzheimer’s Disease

October 2024

The AD landscape is complex but evolving with the recent approval of amyloid-targeting therapies (ATTs), which have enabled an economy built around supporting the new unmet needs created by these therapies

Barriers to address for improving patient outcomes

Diagnosis
  • PCPs are not set up for success to provide adequate workup
  • Current cognitive and functional tests have limitations and require repeat testing to detect decline over time
  • Blood biomarkers (BBMs) can address some of these limitations but are yet to be FDA-approved
  • The use of AI technology can help accelerate image processing and interpretation, aiding with diagnosis

Integration
  • AI-powered software that can seamlessly integrate with MRI and PET scan devices could alleviate long waiting time
  • Hiring and training required personnel needed to carry out all required steps for diagnosis and medication administration (eg, there is a need for more radiologists as current imaging centers have bandwidth issues)
  • There currently appear to be no major partnerships between companies providing AI-powered software and care systems

On this page, we will provide an overview on the use of AI-powered software for MRI and PET scan imaging interpretation, including the landscape, available tests, and industry trends

EXECUTIVE SUMMARY – THE AI LANDSCAPE SPACE TODAY

AI-powered software tackling some of the main unmet need have already been developed and are currently awaiting FDA 510(k) approval

Current AI-powered software are designed for a broader usein neurology

  • Current AI-powered software have been developed for not only Alzheimer’s disease but for a larger number of neurodegenerative diseases, such as looking at changes in white and grey matter and volumetric changes
  • The approval of ATTs has created a new set of needs and challenges that current approved products do not address, like the need for centiloid count on PET scans

 

Adding functionalities such as ARIA monitoring can help address some of the unmet needs created by ATTs

  • Software addressing some of the unique unmet needs like detecting and monitoring for ARIA are currently awaiting FDA 510(k) approval and could be granted as early as Q1 2025
  • Different pricing models, such as subscription-based models or pay-as-you-go models, could help with the adoption of these technologies in large and small healthcare systems

Did you know?

ARIA is one of the side effects of monoclonal antibodies directed to amyloid beta aggregates such as lecanemab and donanemab​

EXECUTIVE SUMMARY – THE FUTURE AI IMAGING LANDSCAPE

Ease of integration and additional features that can aid with image interpretation and diagnosis will be key moving forward

AI software Icon

Unmet need: Testing for multiple targets yields the most promising outcomes

Future trends: Ability to detect ARIA-E and ARIA-H events and additional features, such as the ability to detect the potential risk of developing ARIA, could help improve the safety of ATT

Unmet need: Most companies currently only offer one payment system, although some have shifted to provide multiple options

Future trends: Having different pricing models for different healthcare systems could help those with large or small volume of patients

Unmet need: The need to integrate with a cloud-based AI could help with faster computation and analysis but have the risk of not being available if there are connectivity issues

Future trends: Products that don’t over-rely on an internet connection for some of their key features could bypass this issue, although computational analysis could be compromised

There is great potential for the use of AI in helping neurologists and radiologists with diagnosis and monitoring for safety, yet FDA approval is critical for their adoption in the real world

Detailed Report

AI imaging could be used alongside BBMs to reduce the need for CSF testing in AD; however, it is unlikely to replace CSF testing as a standalone modality in the near-term

Drivers of AI-Driven Imaging Adoption

Driver

Decreased Scan Time

Description

Studies have shown up to 4x faster scan times with AI processing tools1.

Stakeholder Benefit*

Increased machine availability would allow imaging centers to scan a greater volume of patients

*Benefit: Gain to stakeholder resulting from increased MRI/PET usage

Driver

Increased Confidence in Scan Quality

Description

Real-time motion tracking and gating optimization, and post-processing AI tools could correct for motion artifact in MRI and PET scans

Stakeholder Benefit*

Greater scan quality would reduce the need for repeat scans and patient callbacks, minimizing unnecessary strain on imaging facilities

Movement correction would allow for roomier, less restrictive scanners, reducing patient discomfort

Driver

Enhancement of Weaker Scanners

Description

Improved accuracy and resolution may enable 1.5T magnetic field strength scanners to approach the quality of 3T scanners, which are 30%-40% more expensive2,3.

Stakeholder Benefit*

A broadened network of capable scanners would improve patient access to minimally-invasive diagnostics.
1NYU Langone Health NewsHub; 2Siemens Healthineers; 3LBN Medical

Did You Know Icon

Critical Implication Given current capabilities, AI-driven imaging is expected to be used alongside BBMs in the near term

With an increase in AI-powered software, the ability to integrate with imaging devices, unique software features, and pricing models will help differentiate currently available options for AD

As the number of AI-powered software solutions continues to increase, so does the competition with these three areas being key components that will help differentiate products in the space

Integration

Most software offers the ability to integrate with Picture Archiving and Communication Systems (PACS), but not all are accompanied by additional stand-alone/third-party or web-based platforms that could help differentiate themselves from the competition by offering seamless user experiences

Software features

Key features like the ability to detect ARIA in patients undergoing ATT, volumetric measurements of white or grey matter, or to perform contrast weighted images, or multi-time-point or normative comparisons will also determine which software can offer the best set of features that respond to healthcare system needs

Pricing models

Accommodating pricing models can be matched to needs of institution type; for example, subscription based for large institutions or pay as you go for smaller radiology centers

With an increase in AI-powered software, the ability to integrate with imaging devices, unique software features, and pricing models will help differentiate currently available options for AD

ProductCompanyIntegrationKey features
Pixyl.Neuro.BV1PixylIntegration in standard reading environment (PACS), integration via AI marketplace or distribution platform, stand-alone web basedBrain volume quantification, brain segmentation, comparison with normative values, longitudinal analysis
ARIAscore structure2ARIAMedIntegration in standard reading environment (PACS)Brain tissue and anatomy segmentation, volume quantification, normative comparison, report generation, WMH detection and quantification
QyScore3QynapseIntegration in standard reading environment (PACS), integration via AI marketplace or distribution platform, stand-alone web-basedAutomatic labeling and volumetric quantification of segmented central nervous system structures; decreases image reading variability and segmentation errors
Trace4AD4DeepTrace TechnologiesStand-alone third-party application, stand-alone web-basedProvides risk (low or high) of having or progressing to AD within 24 months by an automatic reading of the subject’s brain grey matter obtained from a 3D structural T1-weighted MRI brain study, also in combination with subject’s neuropsychological measures

Product Capabilities

ProductDetection/diagnosisPrognosisMonitoringARIA detection
Pixyl.Neuro.BV1CheckboxCheckbox
ARIAscore structure2CheckboxCheckboxCheckbox
QyScore3CheckboxCheckbox
Trace4AD4CheckboxCheckbox

FDA Clearance and Pricing

ProductCompanyFDA clearance dateKey featuresPricing model
SubtlePET1Subtle Medical12/5/2018SubtlePET image processing software reduces noise to increase image quality using a deep neural network-based algorithm; “denoises images conducted in 25% of the original scan duration”Unknown
Neurocloud PET2QubiotechNot yet (CE certified, Class I)Identify and quantify regions with abnormal metabolism, positive/negative amyloid result, customizable reportPay-per-use, Subscription, Customizable Plans
Neurophet SCALE PET3Neurophet08/05/2022Quantifies SUVR of biomarkers (e.g., amyloid, tau) targeted by various radiotracers using PET images; Accurately measures atrophy of white matter and grey matter caused by neurodegenerative disorders to provide analysis results and SUVR calculation for 91 brain regionsSubscription, one-off payment; based on pay-per-scan
PalRe™4PAIREUnknownSupports decision-making by detecting and segmenting lesions on PET scans to extract features that require attentionUnknown
ProductNoise reductionDetection/diagnosisMonitoring
SubtlePET1Checkbox  
Neurocloud PET2 CheckboxCheckbox
Neurophet SCALE PET3 Checkbox 
PalRe™4 Checkbox 

Detection and Monitoring

ProductKey featuresDetection/diagnosisMonitoring
Neurocloud PET3Identify and quantify regions with abnormal metabolism, positive/negative amyloid result, customizable reportCheckboxCheckbox
Neurophet SCALE PET4Quantifies SUVR of biomarkers (e.g., amyloid, tau) targeted by various radiotracers using PET images; Accurately measures atrophy of white matter and grey matter caused by neurodegenerative disorders to provide analysis results and SUVR calculation for 91 brain regionsCheckbox

ARIA Detection Capabilities

ProductKey featuresARIA detection
Neurophet AQUA AD1Brain region segmentation, volume quantification, normative comparison, report generation, white matter hyperintensity quantification, multi-time-point analysis, ARIA monitoringCheckbox
icobrain aria2Automated quantification of ARIA-E and ARIA-HCheckbox

Key Benefits

Faster Results Icon

Faster Results

Objective Analysis Icon

Objective and Comparative Analysis

Improved Accuracy Icon

Improved Accuracy of Diagnosis

Organized Reporting Icon

Comprehensive and Organized Reporting

Tracking Disease Progression Icon

Methods for Tracking Disease Progression

Standardization Icon

Standardization

Blood Biomarkers in Alzheimer’s Disease


Blood Biomarkers in Alzheimer’s Disease

The AD landscape is complex but evolving addressing diagnosis bottlenecks, infrastructure support/access issues, and cost considerations is crucial for improving patient outcomes.

Barriers to address for improving patient outcomes

Diagnosis
  • PCPs are not set up for success to provide adequate workup.
  • Current cognitive and functional tests have limitations and require repeat testing to detect decline over time.
  • Blood biomarkers (BBMs) can address some of these limitations but have had a slow uptake.

Infrastructure
  • Hiring and training required personnel needed to carry out all required steps for diagnosis and medication administration (e.g., staff at infusion and MRI centers).

Support/Access
  • Patients’ access to HCPs is limited (e.g., geographic location, HCP limited time).
  • Caregiver support is essential and is often overlooked when setting up patient appointments.

Cost
  • High cost of approved therapies is a barrier to access for patients even though they are most effective and offer cost savings when introduced early.
  • Other factors should be considered, such as care partners’ ability to continue working while the patient remains in the earlier stages longer.

On this page, we will provide an overview on diagnosis with a specific focus on BBMs, including the landscape, available tests, accessibility, accuracy of data, and upcoming pipeline and industry trends.

EXECUTIVE SUMMARY – THE BBM SPACE TODAY

Despite rapid expansion in BBM development, significant hurdles remain to reach broad adoption in AD1

Challenges with Current AD Biomarker Tests2,3

  • The gold standard for Aβ and tau measurements involves costly and invasive PET and CSF tests.
  • There is a need for less invasive and cost-effective alternatives.

 

BBM tests1,2,4

  • Have the potential to address unmet needs because they:
    • Limit the number of patients that require a confirmatory PET scan.
    • Help with earlier diagnosis of AD.
  • Current limitations include:
    • Age-dependent accuracy.
    • Results influenced by comorbidities such as hypertension or CKD.

Did you know?

Because of the multiple steps in the diagnosis of AD, the average predicted wait time between clinical diagnosis and treatment is 18.6 months4
4.

EXECUTIVE SUMMARY – THE FUTURE BBM LANDSCAPE

Slow adoption of BBM tests is poised to shift, driven by outcomes of combination targets, greater coverage and reimbursement, and increased investments, reflecting growing confidence in BBMs in AD diagnosis.

BBM Tests Icon

Testing for multiple targets yields the most promising outcomes

Previous BBM tests examined individual targets. Recent approvals in the market show a shift toward a stronger emphasis on simultaneously assessing various targets (i.e., Aβ and p-tau 217).

Wider insurance coverage and improved reimbursement will enhance BBM accessibility for AD diagnosis

With the emergence of DMTs, we anticipate that more BBM tests will secure CPT codes, insurance coverage, and reimbursement protocols, accelerating their adoption.

Increasing investments and strategic partnerships underscore a high level of confidence in the potential of BBM testing

These collaborations not only demonstrate a commitment to advancing BBM technologies, but also indicate a growing belief in their ability to make a meaningful impact on AD diagnosis.

Despite an initial sluggish adoption, emerging trends point toward the anticipated expansion of BBMs in clinical practice.

Detailed Findings

Amyloid beta and tau are the primary biomarkers of Alzheimer’s disease, which are currently measured via CSF or PET scans2,5

Amyloid beta (Aβ)6

Doctor Icon

Plasma Aβ42/40 levels are abnormal during the presymptomatic disease stages making earlier screening and diagnosis possible.

Chart Down Icon

A lower Aβ42/40 ratio corresponds to Aβ presence in the brain.

P-tau

Doctor Icon

Plasma p-tau levels are related to both the density of Aβ plaques and tau tangles.

Chart Down Icon

P-tau levels increase across the AD continuum, including the asymptomatic phase in sporadic and genetic forms of AD7

Given the multistep nature of AD diagnosis, more accessible testing methods are needed to help with timely and accurate AD diagnosis and intervention

Doctor Icon

AD often isn’t diagnosed until a patient has progressed to the mild dementia stage of the disease8

People Icon

About one-third of people with MCI due to AD develop AD dementia within 5 years, and each day >2000 adults may transition to moderate AD9

Hourglass Icon

Progression past the MCI stage can lead to ineligibility for certain AD treatments10

Patient presents with suspected cognitive changes | Assess cognition with diagnostic tools sensitive to MCI and mild AD dementia (eg, MoCA, MMSE, Mini-Cog) | Use structural imaging to rule out other conditions that may cause symptoms similar to AD (eg, MRI and CT scans)

Routine screening of adults >65 or individuals with risk factors for AD could identify more patients before they progress to mild dementia.

More affordable and accessible testing could reduce time from initial cognitive changes to formal diagnosis.

Did You Know Icon

Did you know? Because of the multiple steps in the diagnosis of AD, the average predicted wait time between clinical diagnosis and treatment is 18.6 months15.

Assessment via BBMs have the potential to be an important part of the path to treatment and are a growing focus area

Overview of BBMs

Drivers:

  • Enable earlier diagnosis for patients over 65, particularly in mild cognitive impairment (MCI) and early Alzheimer’s disease (AD)1
  • Reduce misdiagnosis
  • Provide greater access to biomarker-based measures compared to expensive and invasive PET/CSF tests

Barriers:

  • Lack of regulatory approval for BBMs
  • BBMs should complement, not replace, clinical assessments16
  • High variability in disease progression among individuals with positive biomarkers17
  • BBMs are not yet established in clinical practice, requiring physician education

As the field’s understanding of BBM use and limitations in the AD space increases, so does the number of in-development and commercially available tests

TestManufacturerAvailabilityTargetAccuracy Data
AD-Detect18QuestAvailable for useAmyloid beta, p-tau181, p-tau 217Sensitivity: 71
Specificity: 89%
PrecivityAD19C2NAvailable for useAmyloid beta 42/40 ratioSensitivity: 88%
Specificity: 89%
Accuracy: 86%
PrecivityAD220C2NAvailable for useAmyloid beta 42/40 and p-tau 217/np-tau 217 ratioSensitivity 88%
Specificity 89%
ALZpathDx21ALZpathAvailable for useAmyloid beta and p-tau 217Accuracy: 92%
P-Tau 21722,23Mayo ClinicAvailable for useP-tau 217Accuracy: 94%
ALZmetrix TM24PharmaKureCompleted clinical trialAmyloid beta, α-synuclein, p-tau 181, and p-tau 217Accuracy: 97%
Elecsys25,26Roche/LillyOngoing clinical trialsAmyloid beta or p-tau 217Data not yet released
LucentAD27QuanterixResearch use onlyP-tau 217Accuracy: >90%
AB42 and TTAU28Siemens HealthineersN/AAmyloid beta and tauData not yet released
ALZpath p-tau 21729,30AlamarN/AResearch onlyAccuracy: >90%
Equipment dependent test31FujirebioResearch use onlyAmyloid beta (1-40,1-42) and tau (p-181, p-217)N/A

Did you know?

A breakthrough device must file for FDA 510(k) clearance when there is low to moderate risk for the device and there is a legally marketed predicated device32.

Scientific evidence has driven companies to offer tests that measure both Aβ and p-tau to obtain a more accurate assessment of AD

TestManufacturerCLIA certifiedAvailabilityTargetAccuracy Data
AD-Detect18QuestYesAvailable for useAmyloid beta, p-tau 181, p-tau 217Sensitivity: 71%, Specificity: 89%
PrecivityAD19C2NYesAvailable for useAmyloid betaSensitivity: 88%, Specificity: 89%, Accuracy: 86%
PrecivityAD220C2NYesAvailable for useAmyloid beta 42/40 and p-tau 217/np-tau 217 ratioSensitivity 88%, Specificity 89%
Simoa® ALZpath21ALZpath, QuanterixYesAvailable for useP-tau 217Accuracy: 95%
ALZmetrix TM22PharmaKureN/ACompleted clinical trialAmyloid beta, α-synuclein, p-tau 181 and p-tau 217Accuracy: 97%
Phospho-Tau 21722,23Mayo ClinicYesAvailable for useP-tau 217Accuracy: 94%
Elecsys23,24Roche/LillyN/AOngoing clinical trialsAmyloid beta or p-tau 217Data not yet released

Earlier developed tests were primarily designed to screen for Aβ.

There has been a shift toward the development of tests screening for p-tau 217 and others that simultaneously screen for multiple markers.

C2N, ALZpath, and Quanterix, and Roche and Eli Lilly’s plasma tests for Aβ and p-tau 217 have received the FDA Breakthrough Device Designation23-26,33.

Did you know?

The average review time for breakthrough devices with 510(k) clearance is 152 days34.


Lack of insurance coverage hinders the adoption of BBMs, but the promise of expanded coverage and reimbursement in the future can spur their acceptance and use

CPT CodeDescription
0206UNeurology (Alzheimer’s disease); cell aggregation using morphometric imaging and protein kinase C-epsilon (PKCε) concentration in response to amylospheroid treatment by ELISA, cultured skin fibroblasts, each reported as positive or negative for Alzheimer’s disease DISCERN™, NeuroDiagnostics, NeuroDiagnostics
0207UNeurology (Alzheimer’s disease); quantitative imaging of phosphorylated ERK1 and ERK2 in response to bradykinin treatment by in situ immunofluorescence, using cultured skin fibroblasts, reported as a probability index for Alzheimer’s disease DISCERN™, NeuroDiagnostics, NeuroDiagnostics
0289UNeurology (Alzheimer’s disease); mRNA, gene expression profiling by RNA sequencing of 24 genes, whole blood, algorithm reported as predictive risk score MindX Blood Test™, MindX Sciences™ Laboratory
0346UBeta amyloid, Aβ40 and Aβ42 by liquid chromatography with tandem mass spectrometry (LC-MS/MS), ratio, plasma QUEST AD-Detect™ Beta Amyloid 42/40 Ratio, Plasma, Quest Diagnostics
0358UNeurology (mild cognitive impairment); analysis of β-amyloid 1-42 and 1-40, chemiluminescence enzyme immunoassay, cerebral spinal fluid, reported as positive, likely positive, or negative Lumipulse® G βAmyloid Ratio (1-42/1-40) Test, Fujirebio Diagnostics, Inc, Fujirebio Diagnostics, Inc
0361UNeurofilament light chain, digital immunoassay, plasma, quantitative Neurofilament Light Chain (NfL), Mayo Clinic, Mayo Clinic
0393UNeurology (e.g., Parkinson’s disease, dementia with Lewy bodies); cerebrospinal fluid (CSF), detection of misfolded α-synuclein protein by seed amplification assay, qualitative SYNTap® Biomarker Test, Amprion Clinical Laboratory
0412UBeta amyloid, Aβ42/40 ratio, immunoprecipitation with quantitation by liquid chromatography with tandem mass spectrometry (LC-MS/MS) and qualitative ApoE isoform-specific proteotyping, plasma combined with age, algorithm reported as presence or absence of brain amyloid pathology PrecivityAD® blood test, C2N Diagnostics LLC, C2N Diagnostics LLC
0443UNeurofilament light chain (NfL), ultra-sensitive immunoassay, serum or cerebrospinal fluid (Effective 04/01/2024)
0445Uβ-amyloid (Abeta42) and p-tau (181P) (pTau181), electrochemiluminescent immunoassay (ECLIA), cerebral spinal fluid, ratio reported as positive or negative for amyloid pathology Elecsys® PhosphoTau (181P) CSF (p-tau 181) and βAmyloid (1-42) CSF II (Abeta 42) Ratio, Roche Diagnostics Operations Inc (US owner/operator)
83520Immunoassay for analyte other than infectious agent antibody or infectious agent antigen; quantitative; not otherwise specified
84999Unlisted chemistry procedure [when specified as tau protein, amyloid beta peptide testing other than long form Aβ, Aβ1-42, Beta-amyloid (1-42), and Abeta42 in CSF specimen or neural thread protein biochemical testing]

Coverage & reimbursement is restricted

  • BBMs currently lack medical necessity status and require stronger evidence for clinical use
  • Due to their novelty, private insurance payers, Medicare, and Medicaid do not currently provide coverage for BBMs
  • BBM test manufacturers are actively pursuing reimbursement for their products

BBM CPT codes are limited

Only 2 BBM tests currently have corresponding CPT codes35,36

High OOP Costs for tests

  • Patients need to pay out-of-pocket for biomarker tests since they are not covered by insurance
  • The cost per test varies by manufacturer; the QUEST-AD Detect test is priced at $399 plus a physician service fee, while the PrecivityAD test costs approximately $1,20037-39
  • C2N Diagnostics emphasizes potential cost savings of $643 per identified case of Alzheimer’s disease

The use of BBMs to detect and diagnose Alzheimer’s disease early could lead to an increase in the number of patients receiving potentially life-changing treatment.


The use of BBMs to detect and diagnose Alzheimer’s disease early could lead to an increase in the number of patients receiving potentially life-changing treatment.

BBMs can have a significant impact on the diagnosis and monitoring of Alzheimer’s disease, benefiting both patients and physicians, if current challenges are overcome by:

Patient Identification Icon

Allowing for patient identification at the PCP level

Early Detection Icon

Detecting patients in the earliest stages of AD

PET Scan Icon

Limiting the need for a confirmatory PET scan

Early Intervention Icon

Leading to early intervention, maximizing the effectiveness of approved therapies

Caregiver Burden Icon

Reducing the burden on caregivers

BBM tests have the potential to shape the AD neurodiagnostic landscape46

Diagnosis Icon

When used in combination with clinical and cognitive evaluation, the role of BBM in clinical practice may assist in diagnosis/prognosis and in monitoring changes related to the disease-modifying treatment, supporting the safe and effective use of treatment in the future, while PET/MRI is expected to only be necessary for borderline BBM measures.

Research Icon

While BBM tests are not ready to be a stand-alone diagnostic in any clinical setting, more research and clinical trials may improve these tests to the point where they can be widely used to screen for AD risk.

Screening Icon

BBM tests, along with diagnosis dynamics and advances in screening, could change the way AD is detected, resulting in earlier detection and improved patient outcomes.

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