New IDEAS Study Aims and Objectives

To compare 12-month claims-derived health outcomes in amyloid PET-positive versus amyloid PET-negative individuals presenting with MCI and dementia in the entire study cohort of diverse Medicare beneficiaries.

Primary Objective

To compare the proportions of participants with a hospitalization within 12 months, between amyloid PET-positive and amyloid PET-negative participants in the study, separately for patients with MCI and dementia.

Secondary Objectives

1. To compare the proportions of participants with an ED visit within 12 months, between amyloid PET-positive and amyloid PET-negative participants in the study, separately for patients with MCI and dementia.
2. To compare the proportions of participants who had a preventable hospitalization (i.e., related to ambulatory care-sensitive conditions) within 12 months, between amyloid PET-positive and amyloid PET-negative participants, separately for patients with MCI and dementia.
3. To compare overall resource utilization within 12 months between amyloid PET-positive and amyloid PET-negative study participants, separately for patients with MCI and dementia.

Exploratory Objective

To evaluate whether the association of amyloid PET result with 12-month hospitalizations is mediated by changes in each component of the composite management endpoint.

To describe the association of amyloid PET findings with changes in patient management and 12-month claims-derived health outcomes among Blacks/African Americans, Latinos/Hispanics and Whites/Caucasians presenting with MCI and dementia.

Primary Objective

In each ethnoracial subgroup and level of impairment (MCI or dementia), to estimate the rate (proportion) of change between the pre-PET care plan and the 90-day implemented post-PET care plan, in a composite defined as change in one or more of the following items:

• AD-specific medications (cholinesterase inhibitors and memantine)
• Non-AD medications related to CNS conditions or risk factors
• Counseling about safety and future planning

Secondary Objectives

1. In each ethnoracial subgroup, to compare the proportions of participants with a hospitalization or ED visit within 12 months, between amyloid PET-positive and amyloid PET-negative participants in the study.
2. In each ethnoracial subgroup, to compare the proportions of participants with preventable hospitalizations over 12 months, between amyloid PET-positive and amyloid PET-negative participants in the study.

Exploratory Objectives

1. To assess and compare the prevalence of amyloid PET positivity in Blacks/African-Americans and Latinos/Hispanics to Whites/Caucasians, separately for MCI and dementia.
2. To assess the positive and negative predictive values of ApoE4 for amyloid positivity in Blacks/African Americans and Latinos/Hispanics to Whites/Caucasians.
3. To assess and compare the level of cognitive impairment (proportion of MCI vs. dementia) at study entry (pre-PET visit) in Blacks/African Americans and Latinos/Hispanics vs. Whites/Caucasians.
4. To assess and compare the use of AD medications at study entry (pre-PET visit) in Blacks/African Americans and Latinos/Hispanics vs. Whites/Caucasians.

To describe the association of amyloid PET findings with changes in management and 12-month claims-derived health outcomes in individuals presenting with typical (progressive amnestic) versus atypical clinical presentations of MCI and AD dementia.

Primary Objective

To assess and compare the proportion of change in the composite management endpoint in patients with “typical” (progressive amnestic) versus atypical clinical presentations of AD, separately for MCI and dementia

Secondary Objectives

1. To assess and compare the proportions of participants with a hospitalization within 12 months, between amyloid PET-positive and amyloid PET-negative participants in the study, separately for patients with typical versus atypical clinical presentations of AD
2. To assess and compare rates of 12 month hospitalizations, ED visits, preventable hospitalizations and overall resource utilization between patients with typical versus atypical clinical presentations of AD.
3. To assess and compare the proportion of change in the composite management endpoint in patients with “typical” (progressive amnestic) versus atypical clinical presentations of AD, separately for MCI and dementia.

Exploratory Objective

To assess the association between change in the composite management primary endpoint and the following potential predictors and interactions:

• Age (dichotomized at age 65)
• Level of cognitive impairment (MCI vs. dementia)
• Typical vs. atypical clinical presentation
• ApoE4 carriers vs. non-carriers
• Race / Ethnicity
• Medical co-morbidities (documented in pre-PET form

1. Biorepository
   
   To collect and bank plasma and DNA from this unique, practice-based sample of cognitively impaired patients. These samples will serve as a resource to the field, enabling the testing and validation of emerging genetic and blood biomarkers that predict brain amyloidosis, and may, in the future, enable a multi-tiered, cost-effective approach for determining which select patients should undergo amyloid PET. Saliva will be collected from all study participants for DNA analysis. After analysis, saliva samples will be destroyed. Plasma and DNA will be extracted from whole blood samples, and stored for future research, from those participants who specifically consent to blood collection.


2. PET Image Collection
   
   Amyloid PET images of consenting patients will be collected, archived, and serve as a resource for future research.