Registry for Alzheimer's Disease Treatment with Monoclonal Antibodies
Cognitive Neurology Unit's Anti-amyloid Monoclonal Antibodies for the Treatment of Alzheimer's Disease Clinical Registry
This study is creating a registry to see if a new treatment for Alzheimer's disease can help people with early symptoms feel better and slow down their decline.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 500 (estimated) |
| Ages | 50 Years to 95 Years |
| Sex | All |
| Sponsor | Beth Israel Deaconess Medical Center Academic / other |
| Drugs / interventions | aducanumab, lecanemab |
| Locations | 1 site (Boston, Massachusetts) |
| Trial ID | NCT05925621 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are individuals diagnosed with mild cognitive impairment or early dementia due to Alzheimer's disease, who meet specific neuropsychological and imaging criteria.
Not a fit: Patients with moderate dementia, recent strokes, or those on certain immunosuppressive treatments may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide insights into effective treatments for slowing the progression of Alzheimer's disease.
How similar studies have performed: Other studies have shown promise with anti-amyloid monoclonal antibodies, but this specific registry approach is novel.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Boston, Massachusetts
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.