Clinical trial NCT05925621: Cognitive Neurology Unit Clinical Registry
Official title: Cognitive Neurology Unit's Anti-amyloid Monoclonal Antibodies for the Treatment of Alzheimer's Disease Clinical Registry
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Alzheimer Disease
Lead sponsor: Beth Israel Deaconess Medical Center
Sponsor class: OTHER
First posted: 2023-06-29
Enrollment: 500
Sex: ALL
Minimum age (years): 50
Maximum age (years): 95
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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

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

Primary outcomes:
measure: To Determine Whether Anti-Amyloid Mabs Slow Cognitive And Functional Decline
timeFrame: 30 months
measure: To Identify Any Associations Between Side Effects And Patient Characteristics
timeFrame: 30 months
measure: To Establish The Time Course Of Clinical Benefits
timeFrame: 30 months
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center
state: Massachusetts
Study officials:
References: