Cognitive Neurology Unit Clinical Registry
Recruiting · NCT05925621 · Observational (researchers observe without assigning treatment) · Lead sponsor: Beth Israel Deaconess Medical Center
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
A Prospective Comparative Study Of Monoclonal Antibodies For The Treatment Of Alzheimer's Disease
Who can take part
Age range
50 Years to 95 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not specified
Study type
Observational (researchers observe without assigning treatment)
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 is running
1 location listed across 1 US state.
- Beth Israel Deaconess Medical Center - Boston, Massachusetts, United States