RecruitingNCT05925621
Cognitive Neurology Unit Clinical Registry
Cognitive Neurology Unit's Anti-amyloid Monoclonal Antibodies for the Treatment of Alzheimer's Disease Clinical Registry
Sponsor
Beth Israel Deaconess Medical Center
Enrollment
500 participants
Start Date
Jul 16, 2023
Study Type
OBSERVATIONAL
Conditions
Summary
A Prospective Comparative Study Of Monoclonal Antibodies For The Treatment Of Alzheimer's Disease
Eligibility
Min Age: 50 YearsMax Age: 95 Years
Inclusion Criteria10
- 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\*\*
- T 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 Criteria9
- 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
Interventions
DRUGLecanemab
Observational study
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT05925621
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