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

• Status: Active, not recruiting
• Trial end date: 2023-04-28
• Target enrollment: 0
• Participant gender: All

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Eli Lilly and Company

Criteria

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.