Cognitive Neurology Unit Clinical Registry
- Registration Number
- NCT05925621
- Lead Sponsor
- Beth Israel Deaconess Medical Center
- 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
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 500
-
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
-
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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Lecanemab Lecanemab Patients with Alzheimer Disease receiving anti-amyloid mAb therapy at the BIDMC
- Primary Outcome Measures
Name Time Method 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 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 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.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Beth Israel Deaconess Medical Center
🇺🇸Boston, Massachusetts, United States