Principal Investigator: Norman Foster
Keywords: Alzheimer's Disease , Mild Cognitive Impairment , Dementia Department: Alzheimer's Center
IRB Number: 00087369 Co Investigator:  
Specialty: Neurology, Neurology
Sub Specialties: Alzheimer's Disease, Cognitive Disorders
Recruitment Status: Not yet recruiting

Contact Information

Rorie Duprey

Brief Summary

The Imaging DementiaEvidence for Amyloid Scanning (IDEAS) Study will establish an open- label, longitudinal cohort study to assess the impact of amyloid PET on patient outcomes under Coverage with Evidence (CED) in patients meeting 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.

Aim 1: To assess the impact of amyloid PET on the management of patients meeting Appropriate Use Criteria (AUC). [CMS Claims Data to address Aim 1 will be collected for the first 11,050 participants completing both the amyloid PET scan and the Post-PET visit.]

Aim 2: To assess the impact of amyloid PET on hospital admissions and emergency room visits in patients enrolled in the study cohort (amyloid PET-known) compared to matched patients not in the cohort (amyloid PET-naïve) over 12 months. [CMS Claims Data to address Aim 2 will be collected from all participants registered to the longitudinal study cohort [for whom medicare claims are available] and from concurrent controls matched according to a validated algorithm.] 

Inclusion Criteria

4.1 Inclusion Criteria

4.1.1 65 and older; 

4.1.2 Medicare beneficiary with Medicare as primary insurance;

4.1.3 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);

4.1.4 Meets AUC:

- Cognitive complaint with objectively confirmed 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.

4.1.5 Head MRI and/or CT within 24 months prior to enrollment;

4.1.6 Clinical laboratory assessment (complete blood count [CBC], standard blood chemistry profile, thyroid stimulating hormone [TSH], vitamin B12) within the 12 months prior to enrollment;

4.1.7 Able to tolerate amyloid PET required by protocol, to be performed at a participating PET facility;

4.1.8 English or Spanish speaking (for the purposes of informed consent);

4.1.9 Willing and able to provide consent. Consent may be by proxy.

Note: All study procedures are considered standard practice. 

Exclusion Criteria

4.2 Exclusion Criteria

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

4.2.2 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.

4.2.3 Amyloid status already known to patient or referring clinician based on prior amyloid imaging or cerebrospinal fluid analysis.

4.2.4 Current or previous enrollment in an anti-amyloid therapeutic trial.

4.2.5 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.

4.2.6 Scan being ordered for nonmedical purposes (e.g., legal, insurance coverage, or employment screening).

4.2.7 Cancer requiring active therapy (excluding non-melanoma skin cancer);

4.2.8 Hip/pelvic fracture within the 12 months prior to enrollment;

4.2.9 Body weight exceeds PET scanner weight limit;

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

4.2.11 Residence in a skilled nursing facility.