Imaging Dementia—Evidence for Amyloid Scanning (IDEAS) Study: A Coverage with Evidence Development Longitudinal Cohort Study

Investigator: Elizabeth Crocco

Institutional Protocol #: 20151051

National Clinical Trials Identifier: NCT02420756

Funding Agency/Sponsor: American College of Radiology (ACR)

Division: Psychiatry

Therapeutic Area: Other

Phase: N/A

Enrolling Sites: University of Miami Medical Group, Jackson Memorial Hospital

Enrolling Since: 3/29/2017


Purpose/Abstract:


The Imaging Dementia—Evidence for Amyloid Scanning (IDEAS) Study will establish an
open-label, longitudinal cohort study to assess the impact of amyloid PET on patient
outcomes. The study will be performed in accordance with the Center for Medicare & Medicaid
Services (CMS) policy of Coverage with Evidence Development (CED) in Medicare beneficiaries
who meet the Appropriate Use Criteria (AUC) for amyloid PET (Johnson et al. 2013). Our
hypothesis is that amyloid PET will decrease uncertainty and increase confidence in the
underlying cause of cognitive impairment, that this will translate into earlier counseling
and interventions in these domains, and that these interventions will lead to improved
outcomes.




Eligibility Criteria:


Inclusion Criteria:

- 65 and older;

- Medicare beneficiary;

- Diagnosis of MCI or dementia, according to DSM-IV and/or National Institutes of
Aging-Alzheimer's Association criteria, verified by a dementia specialist within 24
months (American Psychiatric Association. 2000; McKhann et al. 2011; Albert et al.
2011);

- Meets AUC:

- Cognitive complaint verified by objectively confirmed cognitive impairment;

- The etiologic cause of cognitive impairment is uncertain after a comprehensive
evaluation by a dementia specialist, including general medical and neurological
examination, mental status testing including standard measures of cognitive
impairment, laboratory testing, and structural neuroimaging as below;

- Alzheimer's disease is a diagnostic consideration;

- Knowledge of amyloid PET status is expected to alter diagnosis and management.

- Head 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.

Exclusion Criteria:

- Normal cognition or subjective complaints that are not verified by cognitive testing.

- 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.

- Scan is being ordered solely based on a family history of dementia, presence of
apolipoprotein E, 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;

- Life expectancy less than 24 months based on medical co-morbidities;

- Residence in a skilled nursing facility.


Gender: All

Minimum Age: 65 Years

Maximum Age: N/A

Accepts healthy volunteers: No

Please note that this is written for scientific review, and if there are any questions or clarifications needed, please contact

Sara Kaplan, Research Associate 1, SOM
(305) 243 6489
skaplan1@miami.edu

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