Cognitive Neurology Unit Clinical Registry

Recruiting

• Conditions: Alzheimer Disease
• Interventions: Drug: Lecanemab

• 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 antibod...

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2023-06-22
• Study First Submitted QC: 2023-06-22
• Study First Posted: 2023-06-29
• Study Start: 2023-07-16
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-26
• Last Update Posted: 2023-09-28
• Primary Completion: 2028-06
• Study Completion: 2028-06

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 500

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

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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

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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.

Trial Locations

Locations (1)

Beth Israel Deaconess Medical Center; 🇺🇸 Boston, Massachusetts, United States