RECRUITING

Cognitive Neurology Unit Clinical Registry

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Official Title

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

Quick Facts

Study Start:2023-07-16

Study Completion:2028-06

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05925621

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:50 Years to 95 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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	* 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

Inclusion Criteria

Exclusion 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

* 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

Contacts and Locations

Study Contact

Dan Z Press, MD

CONTACT

(617) 667-4074

dpress@bidmc.harvard.edu

Chun Lim, MD

CONTACT

(617) 667-4074

clim@bidmc.harvard.edu

Study Locations (Sites)

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215

United States

Collaborators and Investigators

Sponsor: Beth Israel Deaconess Medical Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-07-16

Study Completion Date2028-06

Study Record Updates

Study Start Date2023-07-16

Study Completion Date2028-06

Terms related to this study

Additional Relevant MeSH Terms

Alzheimer Disease