A Study of Health Care Use and Costs in Participants With Early Stage Alzheimer's Disease (AD)

Study Overview
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Brief Summary
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The purpose of this study is to learn about health care use, costs, and clinical outcomes over time for amyloid positive participants with early stages of AD in the United States. This study is for research purposes only, and is not intended to treat any medical condition. No study therapy(ies) for AD will be administered.

Official Title
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Longitudinal Cohort Study of Resource Use and Cost of Mild Cognitive Impairment and Mild Dementia Due to Alzheimer's Disease in the United States (GERAS-US)

Conditions
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Alzheimer Disease, Mild Cognitive Impairment

Intervention / Treatment
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* Drug: Florbetapir F 18 PET Scan


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Presents within normal course of outpatient care for whom the physician deems to meet clinical criteria for MCI due to AD or mild AD dementia. Fully informed written consent of the participant (or his/her legal representative). Study partner who has frequent contact with the participant is willing to accompany the participant at the study observations. Fully informed written consent of the study partner; this person must be willing to serve as study partner for at least 6 months of the year. Able to communicate in English and/or US Spanish. Able to provide evidence of amyloid testing. Has an Mini-Mental State Examination (MMSE) score of 20 or greater. Exclusion Criteria: Are currently enrolled in any other clinical trial involving an investigational product or any other type of medical research judged not to be scientifically or medically compatible with this study at baseline. Are investigator site personnel directly affiliated with this study and/or their immediate families. Immediate family is defined as a spouse, parent, child, or sibling, whether biological or legally adopted. Lack of evidence of amyloid positivity through pre-study test. Note: After baseline assessment, participants with amyloid negativity identified as part of the study will not continue in post-baseline assessments. Are Lilly employees or are employees of any third-party organization (TPO) involved in study who require exclusion of their employees.

Ages Eligible for Study
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Minimum Age: 55 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| MCI (Amyloid Positive)<br>Participants with mild cognitive impairment (MCI) due to AD who tested amyloid positive were observed for up to 36 months. No therapeutic investigational drug intended to treat AD was administered. | Drug: Florbetapir F 18 PET Scan<br>* Florbetapir F 18 positron emission tomography (PET) scan performed at baseline to confirm amyloid status. Participants who previously tested amyloid positive were exempt. No therapeutic investigational drug(s) intended to treat AD will be administered.<br>* Other names: LY3078786;|
| Mild AD Dementia (Amyloid Positive)<br>Participants with mild AD dementia who tested amyloid positive were observed for up to 36 months. No therapeutic investigational drug intended to treat AD was administered. | Drug: Florbetapir F 18 PET Scan<br>* Florbetapir F 18 positron emission tomography (PET) scan performed at baseline to confirm amyloid status. Participants who previously tested amyloid positive were exempt. No therapeutic investigational drug(s) intended to treat AD will be administered.<br>* Other names: LY3078786;|
| MCI (Amyloid Negative)<br>Participants with MCI who tested amyloid negative. These participants were not eligible to participate in the 36 month prospective portion of the study. | Drug: Florbetapir F 18 PET Scan<br>* Florbetapir F 18 positron emission tomography (PET) scan performed at baseline to confirm amyloid status. Participants who previously tested amyloid positive were exempt. No therapeutic investigational drug(s) intended to treat AD will be administered.<br>* Other names: LY3078786;|
| Mild Dementia (Amyloid Negative)<br>Participants with mild dementia who tested amyloid negative. These participants were not eligible to participate in the 36 month prospective portion of the study. | Drug: Florbetapir F 18 PET Scan<br>* Florbetapir F 18 positron emission tomography (PET) scan performed at baseline to confirm amyloid status. Participants who previously tested amyloid positive were exempt. No therapeutic investigational drug(s) intended to treat AD will be administered.<br>* Other names: LY3078786;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Economic Cost Associated with Amyloid Positive AD |  | Baseline through Study Completion (36 Months) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Healthcare Resource Use by AD Cohort |  | Baseline through Study Completion (36 Months) | 
| Mean Economic Cost by AD Cohort |  | Baseline through 24 Months | 
| Bath Assessment of Subjective Quality of Life in Dementia (BASQID) |  | Baseline, End of Study (36 Months) | 
| Mini-Mental State Examination (MMSE) |  | Baseline, End of Study (36 Months) | 
| Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-Cog14) |  | Baseline, End of Study (36 Months) | 
| Neuropsychiatric Inventory (NPI) |  | Baseline, End of Study (36 Months) | 
| Functional Activities Questionnaire (FAQ) |  | Baseline, End of Study (36 Months) | 
| Cognitive Function Inventory (CFI) |  | Baseline, End of Study (36 Months) | 
| Zarit Burden Interview (ZBI) |  | Baseline, End of Study (36 Months) | 
| Percentage of Participants with a Change in Living Situation |  | 36 Months | 
| Time to Transition Across Stages of AD |  | Baseline through Study Completion (36 Months) | 
| Desire to Institutionalize Scale (DTI) |  | Baseline through Study Completion (36 Months) |