A Prospective Comparative Study Of Monoclonal Antibodies For The Treatment Of Alzheimer's Disease
Eligibility
Sex
ALL
Min age
50 Years
Max age
95 Years
Healthy volunteers
No
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 outcome measure(s)
To Determine Whether Anti-Amyloid Mabs Slow Cognitive And Functional Decline — 30 months This study is a prospective, registry-based, single unit, observational study comparing clinical outcome in patients receiving anti-amyloid mAb therapy to historical norms.
To Identify Any Associations Between Side Effects And Patient Characteristics — 30 months This study is a prospective, registry-based, single unit, observational study comparing anti-amyloid mAb therapy patient demographics to clinical outcomes.
To Establish The Time Course Of Clinical Benefits — 30 months This study is a prospective, registry-based, single unit, observational study examining anti-amyloid mAb therapy patient clinical outcomes and adverse effects over time.
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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