A Study of Health Care Use and Costs in Participants With Early Stage Alzheimer's Disease (AD) (GERAS-US)
Alzheimer Disease, Mild Cognitive Impairment

About this trial
This is an observational trial for Alzheimer Disease
Eligibility 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.
Sites / Locations
- California Pharmaceutical Research Institute
- Advanced Research Center
- Sun Valley Research Center
- Global Clinical Trials
- Irvine Clinical Research Center
- Alliance Research Centers
- Pacific Clinical Studies, Inc
- California Neurological Services, Inc.
- Havana Research Institute
- Clinical Innovations, Inc.
- Breakthrough Clinical Trials
- HB Clinical Trials
- Ventura Clinical Trials
- Colorado Neurological Institute
- Coastal Connecticut Research, LLC
- JEM Research Institute
- Visionary Investigators Network
- Research Alliance
- Clinical Research of South Florida
- Infinite Clinical Research
- International Research Partners, LLC.
- Sarkis Clinical Trials
- Indago Research & Health Center, Inc.
- New Life Medical Research Center, Inc
- Galiz Research
- South Florida Clinical Trials
- Van Buren Medical
- Clinical Research of Homestead
- Jacksonville Center for Clinical Research
- Universal Neurological Care
- Sunrise Medical Research
- Empire Clinical Research
- Biomed Research Institute
- Miami Jewish Health Systems
- Florida International Research Center
- The Neurology Research Group, LLC
- L&C Professional Medical Research Institute
- Genoma Research Group, Inc.
- Medical Research Group of Central Florida
- Combined Research Orlando Phase I-IV LLC
- Suncoast Neuroscience Associates
- Stedman Clinical Trials
- Asclepes Research Centers Florida
- Doctors Clinical Research
- American Health Network
- American Research, LLC
- Heartland Research Associates
- Baptist Health Medical Group
- NeuroMedical Clinic of Central Louisiana
- St. Agnes Medical Group
- Hattiesburg Clinic
- University of Mississippi Medical Center
- Psych Care Consultants Research
- Pyramid Clinical Research
- Healthwise Medical Associates, PC
- Integrative Clinical Trials, LLC
- Adirondack Medical Center
- Mid Hudson Medical Research, PLLC
- Onsite Clinical Solutions, LLC
- Onsite Clinical Solutions, LLC
- Alzheimer's Memory Center
- Coastal Carolina Healthcare, P.A.
- Dayton Center for Neurological Disorders
- Christ Hospital
- Family Practice Center of Wooster
- Lynn Health Science Institute
- Thomas Jefferson University
- Wesley Neurology Clinic
- Clinical Research Solutions, P.C.
- Lakeside Life Center
- Univ Of Texas Southwestern at Dallas Childrens Med Ctr
- The Clinical Research Group
- Dallas Clinical Research
- Highlands Medical Associates, P.A.
- University Hills Clinical Research
- North Pointe Psychiatry
- Premier Clinical Research
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
MCI (Amyloid Positive)
Mild AD Dementia (Amyloid Positive)
MCI (Amyloid Negative)
Mild Dementia (Amyloid Negative)
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.
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.
Participants with MCI who tested amyloid negative. These participants were not eligible to participate in the 36 month prospective portion of the study.
Participants with mild dementia who tested amyloid negative. These participants were not eligible to participate in the 36 month prospective portion of the study.