NCT02951598 · ACTIVE NOT RECRUITING
A Study of Health Care Use and Costs in Participants With Early Stage Alzheimer's Disease (AD)
This study is not testing a treatment. It is an observational study tracking how people with early-stage Alzheimer's disease or MCI use health care, what that care costs, and how their condition changes over time. Participants must already have a positive amyloid test. A florbetapir PET scan may be used to confirm amyloid status. There is no experimental drug or therapy involved. Phase is unspecified because this is a research registry, not a clinical intervention trial.
You may qualify if
- 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.
You're excluded if
- 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.
The sponsor's own eligibility wording, lightly reformatted. The study team makes the final eligibility decision — worth discussing with your doctor.
Eligibility criteria as of 2025-10-24