Alzheimer Disease, Mild Cognitive Impairment
Conditions
Brief summary
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.
Interventions
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.
Sponsors
Eli Lilly and Company
Eligibility
Sex/Gender
ALL
Age
55 Years to 85 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mean Economic Cost Associated with Amyloid Positive AD | Baseline through Study Completion (36 Months) |
Secondary
| Measure | Time frame |
|---|---|
| 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) |
| Healthcare Resource Use by AD Cohort | Baseline through Study Completion (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) |
| Functional Activities Questionnaire (FAQ) | Baseline, End of Study (36 Months) |
Countries
United States
Outcome results
None listed