Alzheimer Disease
Conditions
Brief summary
A Prospective Comparative Study Of Monoclonal Antibodies For The Treatment Of Alzheimer's Disease
Detailed description
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
Interventions
DRUGLecanemab
Observational study
Sponsors
Beth Israel Deaconess Medical Center
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
50 Years to 95 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| To Determine Whether Anti-Amyloid Mabs Slow Cognitive And Functional Decline | 30 months | This study is a prospective, registry-based, single unit, observational study comparing clinical outcome in patients receiving anti-amyloid mAb therapy to historical norms. |
| To Identify Any Associations Between Side Effects And Patient Characteristics | 30 months | This study is a prospective, registry-based, single unit, observational study comparing anti-amyloid mAb therapy patient demographics to clinical outcomes. |
| To Establish The Time Course Of Clinical Benefits | 30 months | This study is a prospective, registry-based, single unit, observational study examining anti-amyloid mAb therapy patient clinical outcomes and adverse effects over time. |
Countries
United States
Contacts
Primary ContactDan Z Press, MD
Backup ContactChun Lim, MD
Outcome results
None listed