A Study of Health Care Use and Costs in Participants With Early Stage Alzheimer's Disease (AD)
GERAS-US
Longitudinal Cohort Study of Resource Use and Cost of Mild Cognitive Impairment and Mild Dementia Due to Alzheimer's Disease in the United States (GERAS-US)
2 other identifiers
observational
1,400
1 country
77
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Oct 2016
Longer than P75 for all trials
77 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 28, 2016
CompletedStudy Start
First participant enrolled
October 29, 2016
CompletedFirst Posted
Study publicly available on registry
November 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 30, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
April 28, 2026
CompletedOctober 24, 2025
October 1, 2025
4.3 years
October 28, 2016
October 22, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Mean Economic Cost Associated with Amyloid Positive AD
Baseline through Study Completion (36 Months)
Secondary Outcomes (12)
Healthcare Resource Use by AD Cohort
Baseline through Study Completion (36 Months)
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)
- +7 more secondary outcomes
Study Arms (4)
MCI (Amyloid Positive)
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.
Mild AD Dementia (Amyloid Positive)
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.
MCI (Amyloid Negative)
Participants with MCI who tested amyloid negative. These participants were not eligible to participate in the 36 month prospective portion of the study.
Mild Dementia (Amyloid Negative)
Participants with mild dementia who tested amyloid negative. These participants were not eligible to participate in the 36 month prospective portion of the study.
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.
Eligibility Criteria
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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (77)
California Pharmaceutical Research Institute
Anaheim, California, 92804, United States
Advanced Research Center
Anaheim, California, 92805, United States
Sun Valley Research Center
Imperial, California, 92251, United States
Global Clinical Trials
Irvine, California, 92614, United States
Irvine Clinical Research Center
Irvine, California, 92614, United States
Alliance Research Centers
Laguna Hills, California, 92653, United States
Pacific Clinical Studies, Inc
Los Alamitos, California, 90720, United States
California Neurological Services, Inc.
Panorama City, California, 91402, United States
Havana Research Institute
Pasadena, California, 91105, United States
Clinical Innovations, Inc.
Riverside, California, 92506, United States
Breakthrough Clinical Trials
San Bernardino, California, 92408, United States
HB Clinical Trials
Santa Ana, California, 92704, United States
Ventura Clinical Trials
Ventura, California, 93003, United States
Colorado Neurological Institute
Englewood, Colorado, 80113, United States
Coastal Connecticut Research, LLC
New London, Connecticut, 06320, United States
JEM Research Institute
Atlantis, Florida, 33462, United States
Visionary Investigators Network
Aventura, Florida, 33180, United States
Research Alliance
Clearwater, Florida, 33756, United States
Clinical Research of South Florida
Coral Gables, Florida, 33134, United States
Infinite Clinical Research
Doral, Florida, 33126, United States
International Research Partners, LLC.
Doral, Florida, 33166, United States
Sarkis Clinical Trials
Gainesville, Florida, 32607, United States
Indago Research & Health Center, Inc.
Hialeah, Florida, 33012, United States
New Life Medical Research Center, Inc
Hialeah, Florida, 33012, United States
Galiz Research
Hialeah, Florida, 33016, United States
South Florida Clinical Trials
Hialeah, Florida, 33016, United States
Van Buren Medical
Hollywood, Florida, 33020, United States
Clinical Research of Homestead
Homestead, Florida, 33030, United States
Jacksonville Center for Clinical Research
Jacksonville, Florida, 32216, United States
Universal Neurological Care
Jacksonville, Florida, 32216, United States
Sunrise Medical Research
Lauderdale Lakes, Florida, 33319, United States
Biomed Research Institute
Miami, Florida, 33126, United States
Miami Jewish Health Systems
Miami, Florida, 33137, United States
Florida International Research Center
Miami, Florida, 33173, United States
The Neurology Research Group, LLC
Miami, Florida, 33176, United States
L&C Professional Medical Research Institute
Miami, Florida, 33186, United States
Genoma Research Group, Inc.
Miami, Florida, 66135, United States
Empire Clinical Research
Miami Lakes, Florida, 33018, United States
Medical Research Group of Central Florida
Orange City, Florida, 32763, United States
Combined Research Orlando Phase I-IV LLC
Orlando, Florida, 32807, United States
Suncoast Neuroscience Associates
St. Petersburg, Florida, 33713, United States
Stedman Clinical Trials
Tampa, Florida, 33613, United States
Asclepes Research Centers Florida
Weeki Wachee, Florida, 34607, United States
Doctors Clinical Research
Atlanta, Georgia, 30312, United States
American Health Network
Franklin, Indiana, 46131, United States
American Research, LLC
Jeffersonville, Indiana, 47130, United States
Heartland Research Associates
Newton, Kansas, 67114, United States
Baptist Health Medical Group
Lexington, Kentucky, 40503, United States
NeuroMedical Clinic of Central Louisiana
Alexandria, Louisiana, 71301, United States
St. Agnes Medical Group
Catonsville, Maryland, 21228, United States
Hattiesburg Clinic
Hattiesburg, Mississippi, 39401, United States
University of Mississippi Medical Center
Jackson, Mississippi, 39216, United States
Psych Care Consultants Research
St Louis, Missouri, 63128, United States
Pyramid Clinical Research
Monroe, New Jersey, 08831, United States
Healthwise Medical Associates, PC
Brooklyn, New York, 11206, United States
Integrative Clinical Trials, LLC
Brooklyn, New York, 11229, United States
Adirondack Medical Center
Lake Placid, New York, 12946, United States
Mid Hudson Medical Research, PLLC
New Windsor, New York, 12553, United States
Onsite Clinical Solutions, LLC
Charlotte, North Carolina, 28203, United States
Onsite Clinical Solutions, LLC
Charlotte, North Carolina, 28226, United States
Alzheimer's Memory Center
Charlotte, North Carolina, 28270, United States
Coastal Carolina Healthcare, P.A.
New Bern, North Carolina, 28562, United States
Dayton Center for Neurological Disorders
Centerville, Ohio, 45459, United States
Christ Hospital
Cincinnati, Ohio, 45219, United States
Family Practice Center of Wooster
Wooster, Ohio, 44691, United States
Lynn Health Science Institute
Oklahoma City, Oklahoma, 73112, United States
Thomas Jefferson University
Philadelphia, Pennsylvania, 19107, United States
Wesley Neurology Clinic
Cordova, Tennessee, 38018, United States
Clinical Research Solutions, P.C.
Knoxville, Tennessee, 37920, United States
Lakeside Life Center
Carrollton, Texas, 75010, United States
Univ Of Texas Southwestern at Dallas Childrens Med Ctr
Dallas, Texas, 75390, United States
The Clinical Research Group
Frisco, Texas, 75035, United States
Dallas Clinical Research
Greenville, Texas, 75401, United States
Highlands Medical Associates, P.A.
Highlands, Texas, 77562, United States
University Hills Clinical Research
Irving, Texas, 75062, United States
North Pointe Psychiatry
Lewisville, Texas, 75057, United States
Premier Clinical Research
Spokane, Washington, 99202, United States
Related Publications (1)
Robinson RL, Rentz DM, Bruemmer V, Scott Andrews J, Zagar A, Kim Y, Schwartz RL, Ye W, Fillit HM. Observation of Patient and Caregiver Burden Associated with Early Alzheimer's Disease in the United States: Design and Baseline Findings of the GERAS-US Cohort Study1. J Alzheimers Dis. 2019;72(1):279-292. doi: 10.3233/JAD-190430.
PMID: 31561360DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
Eli Lilly and Company
Study Design
- Study Type
- observational
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 28, 2016
First Posted
November 1, 2016
Study Start
October 29, 2016
Primary Completion
January 30, 2021
Study Completion
April 28, 2026
Last Updated
October 24, 2025
Record last verified: 2025-10
Data Sharing
- IPD Sharing
- Will share
Lilly provides access to the individual patient data from studies on approved medicines and indications as defined by the sponsor specific information on ClinicalStudyDataRequest.com. This access is provided in a timely fashion after the primary publication is accepted. Researchers need to have an approved research proposal submitted through ClinicalStudyDataRequest.com. Access to the data will be provided in a secure data sharing environment after signing a data sharing agreement.