COMPLETED

New IDEAS: Imaging Dementia-Evidence for Amyloid Scanning Study

Conditions

Alzheimer's Disease Dementia Mild Cognitive Impairment

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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

New IDEAS is an observational, open-label, longitudinal cohort study designed to address the requirements of the CED provisions of the NCD on beta-amyloid PET. Building on the initial Imaging Dementia-Evidence for Amyloid Scanning (IDEAS) study, New IDEAS will evaluate the association between amyloid PET and patient-centered outcomes in an expanded and more ethnoracially and clinically diverse group of Medicare participants presenting with cognitive impairment.

Official Title

New IDEAS: Imaging Dementia-Evidence for Amyloid Scanning Study - A Study to Improve Precision in Amyloid PET Coverage and Patient Care

Quick Facts

Study Start:2020-12-17

Study Completion:2024-12-31

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:COMPLETED

Study ID

NCT04426539

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:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
* Medicare beneficiary with Medicare as primary insurance; * Meets clinical criteria for Mild Cognitive Impairment (MCI) or Dementia as defined by the 2018 National Institute on Aging - Alzheimer's Association Research Framework * Brain MRI and/or CT within 24 months prior to enrollment; * Clinical laboratory assessment (complete blood count \[CBC\], standard blood chemistry profile, thyroid stimulating hormone \[TSH\], vitamin B12) within the 12 months prior to enrollment; * Able to tolerate amyloid PET required by protocol, to be performed at a participating PET facility; * English or Spanish speaking (for the purposes of informed consent); * Willing and able to provide consent. Consent may be by proxy; * Neuropsychiatric syndrome can be classified into "clinically typical" or "clinically atypical" categories	* Normal cognition or subjective complaints that are not verified by cognitive testing or key informant. * Knowledge of amyloid status, in the opinion of the referring dementia expert, may cause significant psychological harm or otherwise negatively impact the patient or family. * Amyloid status already known to patient or referring clinician based on prior amyloid imaging or cerebrospinal fluid analysis. * Current or previous enrollment in an anti-amyloid therapeutic trial. * Scan is being ordered solely based on a family history of dementia, presence of apolipoprotein E (ApoE) 4, or in lieu of genotyping for suspected autosomal mutation carriers. * Scan being ordered for nonmedical purposes (e.g., legal, insurance coverage, or employment screening). * Cancer requiring active therapy (excluding non-melanoma skin cancer). * Hip/pelvic fracture within the 12 months prior to enrollment. * Body weight exceeds PET scanner weight limit. * Currently pregnant or planning to become pregnant within 90 days of registration. * Life expectancy less than 24 months based on medical co-morbidities. * Residence in a skilled nursing facility (assisted living facility is not an exclusion criterion).

Inclusion Criteria

Exclusion Criteria

* Medicare beneficiary with Medicare as primary insurance;
* Meets clinical criteria for Mild Cognitive Impairment (MCI) or Dementia as defined by the 2018 National Institute on Aging - Alzheimer's Association Research Framework
* Brain MRI and/or CT within 24 months prior to enrollment;
* Clinical laboratory assessment (complete blood count \[CBC\], standard blood chemistry profile, thyroid stimulating hormone \[TSH\], vitamin B12) within the 12 months prior to enrollment;
* Able to tolerate amyloid PET required by protocol, to be performed at a participating PET facility;
* English or Spanish speaking (for the purposes of informed consent);
* Willing and able to provide consent. Consent may be by proxy;
* Neuropsychiatric syndrome can be classified into "clinically typical" or "clinically atypical" categories

* Normal cognition or subjective complaints that are not verified by cognitive testing or key informant.
* Knowledge of amyloid status, in the opinion of the referring dementia expert, may cause significant psychological harm or otherwise negatively impact the patient or family.
* Amyloid status already known to patient or referring clinician based on prior amyloid imaging or cerebrospinal fluid analysis.
* Current or previous enrollment in an anti-amyloid therapeutic trial.
* Scan is being ordered solely based on a family history of dementia, presence of apolipoprotein E (ApoE) 4, or in lieu of genotyping for suspected autosomal mutation carriers.
* Scan being ordered for nonmedical purposes (e.g., legal, insurance coverage, or employment screening).
* Cancer requiring active therapy (excluding non-melanoma skin cancer).
* Hip/pelvic fracture within the 12 months prior to enrollment.
* Body weight exceeds PET scanner weight limit.
* Currently pregnant or planning to become pregnant within 90 days of registration.
* Life expectancy less than 24 months based on medical co-morbidities.
* Residence in a skilled nursing facility (assisted living facility is not an exclusion criterion).

Contacts and Locations

Principal Investigator

Gil Rabinovici, MD

STUDY_CHAIR

University of California, San Francisco

Study Locations (Sites)

Full list of Active Sites and Imaging Facilities

Philadelphia, Pennsylvania, 19103

United States

Collaborators and Investigators

Sponsor: American College of Radiology

Gil Rabinovici, MD, STUDY_CHAIR, University of California, San Francisco

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 Date2020-12-17

Study Completion Date2024-12-31

Study Record Updates

Study Start Date2020-12-17

Study Completion Date2024-12-31

Terms related to this study

Additional Relevant MeSH Terms

Alzheimer's Disease
Dementia
Mild Cognitive Impairment