NCT05925621 Cognitive Neurology Unit Clinical Registry
| NCT ID | NCT05925621 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Beth Israel Deaconess Medical Center |
| Condition | Alzheimer Disease |
| Study Type | OBSERVATIONAL |
| Enrollment | 500 participants |
| Start Date | 2023-07-16 |
| Primary Completion | 2028-06 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 500 participants in total. It began in 2023-07-16 with a primary completion date of 2028-06.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
A Prospective Comparative Study Of Monoclonal Antibodies For The Treatment Of Alzheimer's Disease
Eligibility 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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT05925621 clinical trial?
This trial is open to participants of all sexes, aged 50 Years or older, up to 95 Years, studying Alzheimer Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05925621 currently recruiting?
Yes, NCT05925621 is actively recruiting participants. Contact the research team at dpress@bidmc.harvard.edu for enrollment information.
Where is the NCT05925621 trial being conducted?
This trial is being conducted at Boston, United States.
Who is sponsoring the NCT05925621 clinical trial?
NCT05925621 is sponsored by Beth Israel Deaconess Medical Center. The trial plans to enroll 500 participants.
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