IDEAS Study

About this trial

Last updated 4 years ago

Study ID

IDEAS Study

Status

Completed

Type

Observational [Patient Registry]

Placebo

Accepting

65+ Years

All

Not accepting

Healthy Volunteers

Trial Timing

Ended 8 years ago

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.

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.

Imaging Dementia-Evidence for Amyloid Scanning (IDEAS) Study