Registry for Alzheimer's Disease Treatment with Monoclonal Antibodies

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study aims to create a registry for patients with Alzheimer's disease (AD) who are treated with anti-amyloid monoclonal antibodies, specifically lecanemab. It will assess the effectiveness of this treatment in slowing cognitive and functional decline in patients with mild cognitive impairment or early dementia. The study will also explore associations between side effects and patient characteristics, as well as establish the time course of clinical benefits from the therapy. Participants will undergo neuropsychological testing and imaging to monitor their condition throughout the treatment period.

Why it matters

Who can join: the full rules

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

Where it's running

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

Study contacts

• Study coordinator: Dan Z Press, MD
• Email: dpress@bidmc.harvard.edu
• Phone: (617) 667-4074

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.