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)

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Alzheimer Disease; Mild Cognitive Impairment
• Intervention / Treatment: Drug: Florbetapir F 18 PET Scan

• Study Type: Observational
• Enrollment (Estimated): 1400

Contacts and Locations

Study Locations

• United States
  • California
    • Anaheim, California, United States, 92805
      • Advanced Research Center
    • Anaheim, California, United States, 92804
      • California Pharmaceutical Research Institute
    • Imperial, California, United States, 92251
      • Sun Valley Research Center
    • Irvine, California, United States, 92614
      • Irvine Clinical Research Center
    • Irvine, California, United States, 92614
      • Global Clinical Trials
    • Laguna Hills, California, United States, 92653
      • Alliance Research Centers
    • Los Alamitos, California, United States, 90720
      • Pacific Clinical Studies, Inc
    • Panorama City, California, United States, 91402
      • California Neurological Services, Inc.
    • Pasadena, California, United States, 91105
      • Havana Research Institute
    • Riverside, California, United States, 92506
      • Clinical Innovations, Inc.
    • San Bernardino, California, United States, 92408
      • Breakthrough Clinical Trials
    • Santa Ana, California, United States, 92704
      • HB Clinical Trials
    • Ventura, California, United States, 93003
      • Ventura Clinical Trials
  • Colorado
    • Englewood, Colorado, United States, 80113
      • Colorado Neurological Institute
  • Connecticut
    • New London, Connecticut, United States, 06320
      • Coastal Connecticut Research, LLC
  • Florida
    • Atlantis, Florida, United States, 33462
      • JEM Research Institute
    • Aventura, Florida, United States, 33180
      • Visionary Investigators Network
    • Clearwater, Florida, United States, 33756
      • Research Alliance
    • Coral Gables, Florida, United States, 33134
      • Clinical Research of South Florida
    • Doral, Florida, United States, 33126
      • Infinite Clinical Research
    • Doral, Florida, United States, 33166
      • International Research Partners, LLC.
    • Gainesville, Florida, United States, 32607
      • Sarkis Clinical Trials
    • Hialeah, Florida, United States, 33016
      • Galiz Research
    • Hialeah, Florida, United States, 33012
      • Indago Research & Health Center, Inc.
    • Hialeah, Florida, United States, 33016
      • South Florida Clinical Trials
    • Hialeah, Florida, United States, 33012
      • New Life Medical Research Center, Inc
    • Hollywood, Florida, United States, 33020
      • Van Buren Medical
    • Homestead, Florida, United States, 33030
      • Clinical Research of Homestead
    • Jacksonville, Florida, United States, 32216
      • Jacksonville Center for Clinical Research
    • Jacksonville, Florida, United States, 32216
      • Universal Neurological Care
    • Lauderdale Lakes, Florida, United States, 33319
      • Sunrise Medical Research
    • Miami, Florida, United States, 33126
      • BioMed Research Institute
    • Miami, Florida, United States, 33137
      • Miami Jewish Health Systems
    • Miami, Florida, United States, 33173
      • Florida International Research Center
    • Miami, Florida, United States, 33176
      • The Neurology Research Group, LLC
    • Miami, Florida, United States, 33186
      • L&C Professional Medical Research Institute
    • Miami, Florida, United States, 66135
      • Genoma Research Group, Inc.
    • Miami Lakes, Florida, United States, 33018
      • Empire Clinical Research
    • Orange City, Florida, United States, 32763
      • Medical Research Group of Central Florida
    • Orlando, Florida, United States, 32807
      • Combined Research Orlando Phase I-IV LLC
    • St. Petersburg, Florida, United States, 33713
      • Suncoast Neuroscience Associates
    • Tampa, Florida, United States, 33613
      • Stedman Clinical Trials
    • Weeki Wachee, Florida, United States, 34607
      • Asclepes Research Centers Florida
  • Georgia
    • Atlanta, Georgia, United States, 30312
      • Doctors Clinical Research
  • Indiana
    • Franklin, Indiana, United States, 46131
      • American Health Network
    • Jeffersonville, Indiana, United States, 47130
      • American Research, LLC
  • Kansas
    • Newton, Kansas, United States, 67114
      • Heartland Research Associates
  • Kentucky
    • Lexington, Kentucky, United States, 40503
      • Baptist Health Medical Group
  • Louisiana
    • Alexandria, Louisiana, United States, 71301
      • NeuroMedical Clinic of Central Louisiana
  • Maryland
    • Catonsville, Maryland, United States, 21228
      • St. Agnes Medical Group
  • Mississippi
    • Hattiesburg, Mississippi, United States, 39401
      • Hattiesburg Clinic
    • Jackson, Mississippi, United States, 39216
      • University of Mississippi Medical Center
  • Missouri
    • St Louis, Missouri, United States, 63128
      • Psych Care Consultants Research
  • New Jersey
    • Monroe, New Jersey, United States, 08831
      • Pyramid Clinical Research
  • New York
    • Brooklyn, New York, United States, 11229
      • Integrative Clinical Trials, Llc
    • Brooklyn, New York, United States, 11206
      • Healthwise Medical Associates, PC
    • Lake Placid, New York, United States, 12946
      • Adirondack Medical Center
    • New Windsor, New York, United States, 12553
      • Mid Hudson Medical Research, PLLC
  • North Carolina
    • Charlotte, North Carolina, United States, 28226
      • OnSite Clinical Solutions, LLC
    • Charlotte, North Carolina, United States, 28203
      • OnSite Clinical Solutions, LLC
    • Charlotte, North Carolina, United States, 28270
      • Alzheimer's Memory Center
    • New Bern, North Carolina, United States, 28562
      • Coastal Carolina Healthcare, P.A.
  • Ohio
    • Centerville, Ohio, United States, 45459
      • Dayton Center for Neurological Disorders
    • Cincinnati, Ohio, United States, 45219
      • Christ Hospital
    • Wooster, Ohio, United States, 44691
      • Family Practice Center of Wooster
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73112
      • Lynn Health Science Institute
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19107
      • Thomas Jefferson University
  • Tennessee
    • Cordova, Tennessee, United States, 38018
      • Wesley Neurology Clinic
    • Knoxville, Tennessee, United States, 37920
      • Clinical Research Solutions, P.C.
  • Texas
    • Carrollton, Texas, United States, 75010
      • Lakeside Life Center
    • Dallas, Texas, United States, 75390
      • Univ Of Texas Southwestern at Dallas Childrens Med Ctr
    • Frisco, Texas, United States, 75035
      • The Clinical Research Group
    • Greenville, Texas, United States, 75401
      • Dallas Clinical Research
    • Highlands, Texas, United States, 77562
      • Highlands Medical Associates, P.A.
    • Irving, Texas, United States, 75062
      • University Hills Clinical Research
    • Lewisville, Texas, United States, 75057
      • North Pointe Psychiatry
  • Washington
    • Spokane, Washington, United States, 99202
      • Premier Clinical Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 51 years to 81 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.	Drug: Florbetapir F 18 PET Scan; 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.; Other Names: LY3078786
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.	Drug: Florbetapir F 18 PET Scan; 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.; Other Names: LY3078786
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.	Drug: Florbetapir F 18 PET Scan; 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.; Other Names: LY3078786
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.	Drug: Florbetapir F 18 PET Scan; 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.; Other Names: LY3078786

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Mean Economic Cost Associated with Amyloid Positive AD	Baseline through Study Completion (36 Months)

Secondary Outcome Measures

Outcome Measure	Time Frame
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)
Neuropsychiatric Inventory (NPI)	Baseline, End of Study (36 Months)
Functional Activities Questionnaire (FAQ)	Baseline, End of Study (36 Months)
Cognitive Function Inventory (CFI)	Baseline, End of Study (36 Months)
Zarit Burden Interview (ZBI)	Baseline, End of Study (36 Months)
Percentage of Participants with a Change in Living Situation	36 Months
Time to Transition Across Stages of AD	Baseline through Study Completion (36 Months)
Desire to Institutionalize Scale (DTI)	Baseline through Study Completion (36 Months)

Collaborators and Investigators

• Sponsor: Eli Lilly and Company
• Investigators: 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

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): October 29, 2016
• Primary Completion (Actual): January 30, 2021
• Study Completion (Estimated): April 28, 2026

Study Registration Dates

• First Submitted: October 28, 2016
• First Submitted That Met QC Criteria: October 28, 2016
• First Posted (Estimated): November 1, 2016

Study Record Updates

• Last Update Posted (Estimated): October 24, 2025
• Last Update Submitted That Met QC Criteria: October 22, 2025
• Last Verified: October 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Mental Disorders; Neurocognitive Disorders; Cognition Disorders; Dementia; Tauopathies; Neurodegenerative Diseases; Cognitive Dysfunction; Alzheimer Disease
• Other Study ID Numbers: 16466; H8A-US-B004 (Other Identifier: Eli Lilly and Company)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD Plan Description

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.