Cognitive Neurology Unit Clinical Registry

Alzheimer Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05925621
• Other study ID #: 2023P000494
• Status: Recruiting
• Start date: July 16, 2023
• Est. completion date: June 2028

Study information

• Verified date: September 2023
• Source: Beth Israel Deaconess Medical Center
• Contact: Dan Z Press, MD
• Phone: (617) 667-4074
• Email: dpress[@]bidmc.harvard.edu
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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

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 information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: June 2028
• Est. primary completion date: June 2028
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 95 Years

Eligibility

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

Related Conditions & MeSH terms

• Alzheimer Disease

Intervention

Drug:
• Lecanemab
Observational study

Locations

Country	Name	City	State
United States	Beth Israel Deaconess Medical Center	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Beth Israel Deaconess Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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