Cognitive Neurology Unit Clinical Registry

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

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

Study Overview

• Status: Recruiting
• Conditions: Alzheimer Disease
• Intervention / Treatment: Drug: Lecanemab

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

• Study Type: Observational
• Enrollment (Estimated): 500

Contacts and Locations

• Study Contact: Name: Dan Z Press, MD; Phone Number: (617) 667-4074; Email: dpress@bidmc.harvard.edu
• Study Contact Backup: Name: Chun Lim, MD; Phone Number: (617) 667-4074; Email: clim@bidmc.harvard.edu

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02215
      • Recruiting
      • Beth Israel Deaconess Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

We will enroll patients under the care of the CNU. All patients with a concern for cognitive impairment secondary to AD interested in receiving anti-amyloid monoclonal antibody therapy will be enrolled into this registry as required by CMS.

• Patients with a diagnosis of AD based on National Institute on Aging and the Alzheimer's Association diagnostic guidelines.
• Patients with a diagnosis of MCI based on the National Institute on Aging and the Alzheimer's Association and Petersen criteria.
• All patients eligible to receive anti-amyloid therapy will have confirmation of AD through a positive amyloid PET.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Lecanemab; Patients with Alzheimer Disease receiving anti-amyloid mAb therapy at the BIDMC	Drug: Lecanemab; Observational study

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Beth Israel Deaconess Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): July 16, 2023
• Primary Completion (Estimated): June 1, 2028
• Study Completion (Estimated): June 1, 2028

Study Registration Dates

• First Submitted: June 22, 2023
• First Submitted That Met QC Criteria: June 22, 2023
• First Posted (Actual): June 29, 2023

Study Record Updates

• Last Update Posted (Actual): September 28, 2023
• Last Update Submitted That Met QC Criteria: September 26, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Neurodegenerative Diseases; Dementia; Tauopathies; Alzheimer Disease
• Other Study ID Numbers: 2023P000494

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Data sets may be shared with members outside the study team following de-identification under approved data use agreements (DUAs) as needed. Within the REDcap database, access to the identifiable information will be limited to study staff members and to staff managing the database. Any data that may require a physical transfer from one place to another will be done using removable encrypted data storage devices.
• IPD Sharing Supporting Information Type: CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No