Specialty Training for the New Era in Alzheimer’s Disease: Building Skills for Making an Early Diagnosis and Implementing Disease-Modifying Treatment
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Chair, Sharon Cohen, MD, FRCPC, prepared useful Practice Aids pertaining to Alzheimer’s disease for this CME/MOC/AAPA activity titled “Specialty Training for the New Era in Alzheimer’s Disease: Building Skills for Making an Early Diagnosis and Implementing Disease-Modifying Treatment.” For the full presentation, downloadable Practice Aids, monograph, and complete CME/MOC/AAPA information, and to apply for credit, please visit us at https://bit.ly/472bp8g. CME/MOC/AAPA credit will be available until May 20, 2025.
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Specialty Training for the New Era in Alzheimer’s Disease: Building Skills for Making an Early Diagnosis and Implementing Disease-Modifying Treatment
- 1. Revised Criteria for Biomarker-Based Diagnosis and Staging of AD1 Full abbreviations, accreditation, and disclosure information available at PeerView.com/VQG40 Core 1 Biomarkers Core 2 Biomarkers Biomarkers of Nonspecific Processes Involved in AD Pathophysiology Biomarkers of Non-AD Co-Pathology Categorization of Fluid and Imaging Biomarkers Biomarker Category CSF Plasma Imaging A (Aβ proteinopathy) Hybrid ratios T2 (AD tau proteinopathy) N (injury, dysfunction, or degeneration of neuropil) I (inflammation) astrocytic activation V (vascular brain injury) S (α-synuclein) – – – Amyloid PET – P-tau217/nP-tau217 pT205 Tau PET P-tau181/Aβ42, T-tau/Aβ42, Aβ42/Aβ40 pT205, MTBR-243, nonphosphorylated tau fragments NfL NfL Anatomic MRI, FDG PET Anatomic infarction, WMH, abundant diluted perivascular spaces – – GFAP GFAP – – – αSyn-SAA – T1 (phosphorylated and secreted AD tau) • Core 1 biomarkers define the initial stage of AD that is detectable in vivo • AD can be diagnosed with any Core 1 biomarker • Core 2 biomarkers develop later than Core 1 biomarkers, and are closely tied to onset of neurodegeneration and clinical symptoms • Core 2 biomarkers can be combined with Core 1 biomarkers to stage biological disease severity P-tau217
- 2. Revised Criteria for Biomarker-Based Diagnosis and Staging of AD1 Full abbreviations, accreditation, and disclosure information available at PeerView.com/VQG40 Core 2 biomarkers can be combined with Core 1 biomarkers to stage biological disease severity and • Provide information on the likelihood that clinical symptoms are associated with AD • Inform the risk of clinical progression in people without symptoms • Inform the likely rate of clinical progression in symptomatic individuals Amyloid PET Tau PET Medial Temporal Region Tau PET Moderate Neocortical Uptake Tau PET High Neocortical Uptake AT Notation Stage A (Initial) + - - - A+T- + + - - A+TMTL + + + + - A+TMOD + + + + + A+THIGH + Stage B (Early) Stage C (Intermediate) Stage D (Advanced) Biological Staging of AD Using Amyloid PET and Tau PET
- 3. Revised Criteria for Biomarker-Based Diagnosis and Staging of AD1 Full abbreviations, accreditation, and disclosure information available at PeerView.com/VQG40 Preclinical AD Stage 1: Clinically asymptomatic, biomarker evidence only Stage 2: Normal performance in expected range on cognitive tests, but decline from previous level of cognitive function, with no or minimal impact on daily function Stage 3: Objective cognitive impairment with early functional impact insufficient to result in significant functional loss Stage 4 (mild dementia): Progressive cognitive and mild functional impairment on instrumental ADLs with independence in basic ADLs Stage 5 (moderate dementia): Progressive cognitive and moderate functional impairment requiring assistance Stage 6 (severe dementia): Progressive cognitive and severe functional impairment causing dependence for basic ADLs Mild Cognitive Impairment Alzheimer's Dementia Clinical Stages of Alzheimer’s Disease
- 4. Revised Criteria for Biomarker-Based Diagnosis and Staging of AD1 Full abbreviations, accreditation, and disclosure information available at PeerView.com/VQG40 • Typical relationship between biology and symptoms moves along an upper left to lower right diagonal (gray cells) • Those in cells above diagonal (ie, worse clinical stage than expected for biological stage; blue cells) are expected to have greater comorbid pathologic change • Those in cells below diagonal (ie, better clinical stage than expected for biological stage; green cells) may have exceptional resilience or cognitive reserve 1. Jack CR et al. Revised criteria for diagnosis and staging of Alzheimer’s disease: Alzheimer’s Association Workgroup. In progress. https://aaic.alz.org/diagnostic-criteria.asp. Clinical Stage 1 Clinical Stage 2 Clinical Stage 3 Clinical Stage 4 Clinical Stage 5 Clinical Stage 6 Initial Biological Stage (A) 1A 1B 1C 2C 1D 2D 3D 2A 3A 4A 5A 6A Early Biological Stage (B) Intermediate Biological Stage (C) Advanced Biological Stage (D) 2B 3B 4B 4C 4D 5B 5C 5D 6B 6C 6D 3C Integrated Biological and Clinical Staging
- 5. Appropriate Use of AD Biomarkers by Modality Full abbreviations, accreditation, and disclosure information available at PeerView.com/VQG40 Clinical Scenarios Appropriate Use for Amyloid PET1 Appropriate Use for Tau PET1 Appropriate Use for CSF Test2 Patients with SCD (cognitively unimpaired based on objective testing) who are at increased risk for AD (eg, due to APOE4 positivity) Patients with MCI or dementia which is consistent with AD pathology (amnestic presentation) with onset at 65 years or older Patients with MCI younger than 65 years and in whom AD pathology is suspected Patients with MCI or dementia that could be consistent with AD pathology but has atypical features Patients with MCI or dementia with equivocal or inconclusive results on recent CSF biomarkers To inform the prognosis of patients presenting with MCI due to clinically suspected AD pathology To inform the prognosis of patients presenting with dementia due to clinically suspected AD pathology To determine eligibility for treatment with an approved amyloid-targeting therapy To monitor response among patients that have received an approved amyloid-targeting therapy If patient has contraindication to lumbar puncture No No Yes Yes Yes Yes Yes No No Yes Yes Yes Yes No No Yes Yes No No Yes No Yes Yes Yes Yes No - Yes No No 1. Rabinovici GD et al. Updated Appropriate Use Criteria for Amyloid and Tau PET in Alzheimer’s Disease. In Progress. https://www.alz.org/media/Documents/AUC-Amyloid-Tau-PET-Alzheimers_Manuscript.pdf. 2. Shaw LM et al. Alzheimers Dement. 2018;14:1505-1521.
- 6. Commercially Available Biomarkers for AD1,2 Full abbreviations, accreditation, and disclosure information available at PeerView.com/VQG40 Test Name (Developer) Biomarker Modality Biomarkers Assay Platform FDA-Approved/ CLIA-Certified/ Breakthrough Device Status Florbetapir (Lilly) Florbetaben (Life Molecular Imaging) Flutemetamol (GE Healthcare) Flortaucipir (Lilly) Flortaucipir (Lilly) Elecsys AD (Roche) Lumipulse G (Fujirebio) AD-Detect (Quest Diagnostics) Amyloid Plasma Panel (Roche, Lilly) ATN Profile (Labcorp) Lucent-AD (Lucent Diagnostics) PrecivityAD (C2N) PrecivityAD2 (C2N) Amyloid PET Amyloid PET Tau PET CSF CSF Plasma Plasma Plasma Plasma Plasma Plasma Amyloid PET Amyloid plaques Amyloid plaques Amyloid plaques Tau aggregates P-tau181/Aβ42, T-tau/Aβ42 Aβ42/40 Aβ42/40 Aβ42/Aβ40, P-tau181, APOE4, P-tau217 Aβ42/Aβ40, P-tau181, NfL P-tau217 Aβ42/40, APOE4 status, age Aβ42/40, P-tau217/ nP-tau217 FDA-approved FDA-approved FDA-approved FDA-approved FDA-approved FDA-approved CLIA-certified CLIA-certified CLIA-certified CLIA-certified CLIA/breakthrough Breakthrough device N/A N/A N/A N/A Elecsys Lumipulse IP-LC-MS/MS Elecsys Simoa Simoa IP-LC-MS/MS IP-LC-MS/MS 1. Pleen J et al. Practical Neurology. 2024;23:27-42. 2. Hampel H et al. Neuron. 2023;111:2781-2799.
- 7. FDA-Approved Digital Cognitive Assessment Tools1 Full abbreviations, accreditation, and disclosure information available at PeerView.com/VQG40 FDA-Approved Digital Cognitive Assessment Tools Can Assist With the Detection of Mild Cognitive Impairment and Dementia in Primary and Specialty Care Settings Digital Cognitive Assessment Tool Domains Measured Administration Time Website Automated Neuropsychological Assessment Metrics (ANAM) Cambridge Neuropsychological Test Automated Battery (CANTAB Mobile®) CognICA Cognigram Cognivue 25 min 35 min 5 min <10 min 10 min • Attention • Concentration • Reaction time • Memory • Attention • Information processing • Memory • Information processing speed • Visual learning • Working memory • Memory • Executive function/attention • Discrimination • Visuospatial • Motor skills • Processing speed • Decision-making • Executive function • Executive function • Motor skills Scan to visit https://vistalifesciences.com/ anam-intro Scan to visit https://cambridgecognition.com/ digital-cognitive-assessments Scan to visit https://cognetivity.com/cognica Scan to visit https://devcd-cognigram.esi-cms.com Scan to visit https://cognivue.com 1. https://www.alz.org/professionals/health-systems-medical-professionals/cognitive-assessment.