Recruiting NCT05925621

Cognitive Neurology Unit Clinical Registry

— Observational Alzheimer Disease

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied: The protocol lists: Lecanemab.
Who it may be relevant to: Registry conditions: Alzheimer Disease. Basic parameters: 50 years — 95 years · All.
What needs checking: Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place: United States
Next step: Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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

Drug Lecanemab
Observational study

Primary outcome measures

To Determine Whether Anti-Amyloid Mabs Slow Cognitive And Functional Decline [Time frame: 30 months]
To Identify Any Associations Between Side Effects And Patient Characteristics [Time frame: 30 months]
To Establish The Time Course Of Clinical Benefits [Time frame: 30 months]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model: Cohort

Study locations

United States · 1 center

Beth Israel Deaconess Medical Center — Boston

Identifiers

NCT: NCT05925621 · 2023P000494

Primary sources (government registries)

ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗