Health TrialsbyHealthPanel

Cognitive Neurology Unit Clinical Registry

ConditionAlzheimer Disease
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age50-95
SponsorBeth Israel Deaconess Medical Center

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial population

We will enroll patients under the care of the CNU. All patients with a concern for cognitive impairment secondary to AD interested in receiving anti-amyloid monoclonal antibody therapy will be enrolled into this registry as required by CMS. * Patients with a diagnosis of AD based on National Institute on Aging and the Alzheimer's Association diagnostic guidelines. * Patients with a diagnosis of MCI based on the National Institute on Aging and the Alzheimer's Association and Petersen criteria. * All patients eligible to receive anti-amyloid therapy will have confirmation of AD through a positive amyloid PET.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Lecanemab

    Drug

    Observational study

Treatment groups

500 Participants
are divided into 1 treatment group
Group A: Lecanemab1 intervention

Trial outcomes

Primary outcomes

1

To Determine Whether Anti-Amyloid Mabs Slow Cognitive And Functional Decline

This study is a prospective, registry-based, single unit, observational study comparing clinical outcome in patients receiving anti-amyloid mAb therapy to historical norms.

Time frame
30 months
2

To Identify Any Associations Between Side Effects And Patient Characteristics

This study is a prospective, registry-based, single unit, observational study comparing anti-amyloid mAb therapy patient demographics to clinical outcomes.

Time frame
30 months
3

To Establish The Time Course Of Clinical Benefits

This study is a prospective, registry-based, single unit, observational study examining anti-amyloid mAb therapy patient clinical outcomes and adverse effects over time.

Time frame
30 months

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Beth Israel Deaconess Medical Center

Lead sponsor

Source ClinicalTrials.gov
Apply now