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Cognitive Neurology Unit Clinical Registry

Cognitive Neurology Unit's Anti-amyloid Monoclonal Antibodies for the Treatment of Alzheimer's Disease Clinical Registry

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
50 Years to 95 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study compares antibody medicines used to treat Alzheimer's disease. It is for people with mild memory or thinking problems, or early dementia, caused by Alzheimer's disease.

A Prospective Comparative Study Of Monoclonal Antibodies For The Treatment Of Alzheimer's Disease

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Have mild thinking problems or early dementia from Alzheimer's disease.
  • Have thinking and memory tests that show problems, but not moderate dementia based on tests or a doctor's judgment.
  • Have a brain scan called an amyloid PET scan and/or spinal fluid tests that support Alzheimer's disease. The listed results are a positive PET scan, a spinal fluid p-Tau/Abeta42 ratio above 0.023, and ABeta42 below 1027.
  • Have had a 3T MRI, a type of brain scan, in the past 6 months.
  • Have a care partner.
  • Get care at an appropriate BI-Lahey amyloid clinic.
  • Be on a stable medicine plan.

Who can't join

  • Had a stroke or suspected TIA (a brief stroke-like event) in the past year.
  • Are pregnant.
  • Have an active immune system disease, including one that makes the body attack itself.
  • Receive whole-body treatment with medicines that suppress the immune system, immune proteins called immunoglobulins, or antibody medicines or related products.
  • Have a bleeding disorder with platelets (blood cells that help stop bleeding) below 50,000 or an INR blood-clotting test result above 1.5.
  • Take warfarin, heparin, or a direct oral blood thinner, or take two antiplatelet medicines that help prevent blood clots.
  • Have dementia or mild thinking problems caused by something other than Alzheimer's disease.
  • Have two copies of the ApoE e4 gene variant.

Simplified for readability. The official criteria below are what the study team uses.

Official 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

Study sites (1)

MA