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

Running, not enrolling

Conditions studied: Alzheimer Disease, Mild Cognitive Impairment

In brief

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.

Key facts

Study ID

NCT02951598

Run by

Eli Lilly and Company

People needed

1400

Starts

2016-10-29

Expected to finish

2026-04-28

Last updated by the study team

2025-10-24

Who can join

Age: 55 and older, up to 85. Sex: any. Healthy volunteers: not accepted.

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 may not qualify 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.

Where it is running

• Advanced Research Center — Anaheim, California, United States
• Sun Valley Research Center — Imperial, California, United States
• Global Clinical Trials — Irvine, California, United States
• Irvine Clinical Research Center — Irvine, California, United States
• Alliance Research Centers — Laguna Hills, California, United States
• Pacific Clinical Studies, Inc — Los Alamitos, California, United States
• California Neurological Services, Inc. — Panorama City, California, United States
• Havana Research Institute — Pasadena, California, United States
• Clinical Innovations, Inc. — Riverside, California, United States
• Breakthrough Clinical Trials — San Bernardino, California, United States
• HB Clinical Trials — Santa Ana, California, United States
• Ventura Clinical Trials — Ventura, California, United States
• Colorado Neurological Institute — Englewood, Colorado, United States
• Coastal Connecticut Research, LLC — New London, Connecticut, United States
• JEM Research Institute — Atlantis, Florida, United States
• Visionary Investigators Network — Aventura, Florida, United States
• Research Alliance — Clearwater, Florida, United States
• Clinical Research of South Florida — Coral Gables, Florida, United States
• Infinite Clinical Research — Doral, Florida, United States
• International Research Partners, LLC. — Doral, Florida, United States
• Sarkis Clinical Trials — Gainesville, Florida, United States
• Indago Research & Health Center, Inc. — Hialeah, Florida, United States
• New Life Medical Research Center, Inc — Hialeah, Florida, United States
• Galiz Research — Hialeah, Florida, United States
• California Pharmaceutical Research Institute — Anaheim, California, United States

Full record on ClinicalTrials.gov

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