Recruiting

Observational Study

Sponsor:

Beth Israel Deaconess Medical Center

Code:

NCT05925621

Conditions

Alzheimer Disease

Eligibility Criteria

Sex: All

Age: 50 - 70+

Healthy Volunteers: Not accepted

Interventions

Lecanemab

Study Details

Brief summary:

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

Conditions

Alzheimer Disease

Study ID

NCT05925621

Start date

Jul 16, 2023

Status verified date

Apr, 2026

Completion date

Jun, 2028

Anticipated

Primary completion date

Jun, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 50 - 70+

Healthy Volunteers: Not accepted

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 Design

Enrollment

500 participants

Anticipated

Interventions and Outcome Measures

Arms

Lecanemab

Patients with Alzheimer Disease receiving anti-amyloid mAb therapy at the BIDMC

Interventions

Lecanemab

Observational study

Primary outcome measure

  • 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 ]

Central Contacts and Locations

Central contacts

Dan Z Press, MD

(617) 667-4074dpress@bidmc.harvard.edu

Chun Lim, MD

(617) 667-4074clim@bidmc.harvard.edu

Locations

Beth Israel Deaconess Medical Center

Recruiting

Boston, Massachusetts, United States, 02215

More Information

Sponsor

Beth Israel Deaconess Medical Center

Last update posted

Apr 13, 2026

Last verified

Apr, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Beth Israel Deaconess Medical Center on 2026-04-13.