Cognitive Neurology Unit Clinical Registry

Study Overview
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Brief Summary
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A Prospective Comparative Study Of Monoclonal Antibodies For The Treatment Of Alzheimer's Disease

Detailed Description
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Alzheimer's disease (AD) is a neurodegenerative disorder associated with brain deposition of extracellular amyloid and intracellular tau. It causes progressive cognitive impairment, especially memory, and is invariably fatal. Currently, there is no effective treatment for AD. A new and promising method involves the use of anti-amyloid-beta monoclonal antibodies (anti-amyloid mAbs) to reduce amyloid accumulation in brain. There are currently two anti-amyloid mABs, aducanumab and lecanemab, approved by the FDA under FDA's accelerated approval pathway. However, so far there is only a single phase 3 study that unequivocally demonstrates clinical efficacy of anti-amyloid mAB therapy1. This study is designed to help determine the therapeutic benefit of anti-amyloid mABs therapy by treating AD patients in our clinic with anti-amyloid mABs and measuring cognitive impairment and functional outcomes over the course of the treatment period and beyond. This study has 4 specific aims. SPECIFIC AIM 1: TO CREATE A CNU ANTI-AMYLOID MONOCLONAL ANTIBODY REGISTRY SPECIFIC AIM 2: TO DETERMINE WHETHER ANTI-AMYLOID MABs SLOW COGNITIVE AND FUNCTIONAL DECLINE SPECIFIC AIM 3: TO IDENTIFY ANY ASSOCIATIONS BETWEEN SIDES EFFECTS AND PATIENT CHARACTERISTICS SPECIFIC AIM 4: TO ESTABLISH THE TIME COURSE OF CLINICAL BENEFITS

Official Title
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Cognitive Neurology Unit's Anti-amyloid Monoclonal Antibodies for the Treatment of Alzheimer's Disease Clinical Registry

Conditions
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Alzheimer Disease

Intervention / Treatment
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* Drug: Lecanemab


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: o Patient meets clinical criteria for mild cognitive impairment or early dementia from Alzheimer's disease Patient has evidence of cognitive impairment on neuropsychological testing Patient has not progressed to the moderate stage of dementia based on neuropsychological testing or clinical judgement Amyloid PET imaging and/or CSF analysis consistent with Alzheimer's disease Amyloid PET imaging positive CSF p-Tau/Abeta42 ration >0.023 and ABeta42 < 1027** 3T MRI in past 6 months Patient has a care partner Patient under the care of an appropriate BI-Lahey amyloid clinic Patient is on a stable medication regimen Exclusion Criteria: o Recent stroke or suspected TIA in the past year Pregnancy Active autoimmune or immunological disease Systemic treatment with immunosuppressants, immunoglobulins, or monoclonal antibodies or their derivatives Bleeding disorder with Plts < 50,000 or INR > 1.5 On warfarin, heparin, or DOAC On dual antiplatelet therapy Non Alzheimer disease cause of dementia/MCI ApoE e4 homozygote

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 95 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Lecanemab<br>Patients with Alzheimer Disease receiving anti-amyloid mAb therapy at the BIDMC | Drug: Lecanemab<br>* Observational study<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To Determine Whether Anti-Amyloid Mabs Slow Cognitive And Functional Decline | This study is a prospective, registry-based, single unit, observational study comparing clinical outcome in patients receiving anti-amyloid mAb therapy to historical norms. | 30 months | 
| To Identify Any Associations Between Side Effects And Patient Characteristics | This study is a prospective, registry-based, single unit, observational study comparing anti-amyloid mAb therapy patient demographics to clinical outcomes. | 30 months | 
| To Establish The Time Course Of Clinical Benefits | This study is a prospective, registry-based, single unit, observational study examining anti-amyloid mAb therapy patient clinical outcomes and adverse effects over time. | 30 months |