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Alzheimer DiseaseGERAS-USNCT02951598

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

An observational study of Alzheimer Disease and Mild Cognitive Impairment, run by Eli Lilly and Company at 77 sites in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 55 to 85 years
Conditions the study is for
Alzheimer Disease, Mild Cognitive Impairment
What is being tested?
Florbetapir F 18 PET Scan
How many people
1,400 participants
Where
77 sitesUnited States
Study dates
29 Oct 2016to 28 Apr 2026
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 55 to 85 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

77 sites in 1 country.

77 sites in 1 country

United States77 sites

  • NeuroMedical Clinic of Central Louisiana

    Alexandria, Louisiana, 71301

  • California Pharmaceutical Research Institute

    Anaheim, California, 92804

  • Advanced Research Center

    Anaheim, California, 92805

  • Doctors Clinical Research

    Atlanta, Georgia, 30312

  • JEM Research Institute

    Atlantis, Florida, 33462

  • Visionary Investigators Network

    Aventura, Florida, 33180

  • Healthwise Medical Associates, PC

    Brooklyn, New York, 11206

  • Integrative Clinical Trials, LLC

    Brooklyn, New York, 11229

  • Lakeside Life Center

    Carrollton, Texas, 75010

  • St. Agnes Medical Group

    Catonsville, Maryland, 21228

  • Dayton Center for Neurological Disorders

    Centerville, Ohio, 45459

  • Onsite Clinical Solutions, LLC

    Charlotte, North Carolina, 28203

  • Onsite Clinical Solutions, LLC

    Charlotte, North Carolina, 28226

  • Alzheimer's Memory Center

    Charlotte, North Carolina, 28270

  • Christ Hospital

    Cincinnati, Ohio, 45219

  • Research Alliance

    Clearwater, Florida, 33756

  • Clinical Research of South Florida

    Coral Gables, Florida, 33134

  • Wesley Neurology Clinic

    Cordova, Tennessee, 38018

  • Univ Of Texas Southwestern at Dallas Childrens Med Ctr

    Dallas, Texas, 75390

  • Infinite Clinical Research

    Doral, Florida, 33126

  • International Research Partners, LLC.

    Doral, Florida, 33166

  • Colorado Neurological Institute

    Englewood, Colorado, 80113

  • American Health Network

    Franklin, Indiana, 46131

  • The Clinical Research Group

    Frisco, Texas, 75035

  • Sarkis Clinical Trials

    Gainesville, Florida, 32607

  • Dallas Clinical Research

    Greenville, Texas, 75401

  • Hattiesburg Clinic

    Hattiesburg, Mississippi, 39401

  • Indago Research & Health Center, Inc.

    Hialeah, Florida, 33012

  • New Life Medical Research Center, Inc

    Hialeah, Florida, 33012

  • Galiz Research

    Hialeah, Florida, 33016

  • South Florida Clinical Trials

    Hialeah, Florida, 33016

  • Highlands Medical Associates, P.A.

    Highlands, Texas, 77562

  • Van Buren Medical

    Hollywood, Florida, 33020

  • Clinical Research of Homestead

    Homestead, Florida, 33030

  • Sun Valley Research Center

    Imperial, California, 92251

  • Global Clinical Trials

    Irvine, California, 92614

  • Irvine Clinical Research Center

    Irvine, California, 92614

  • University Hills Clinical Research

    Irving, Texas, 75062

  • University of Mississippi Medical Center

    Jackson, Mississippi, 39216

  • Jacksonville Center for Clinical Research

    Jacksonville, Florida, 32216

  • Universal Neurological Care

    Jacksonville, Florida, 32216

  • American Research, LLC

    Jeffersonville, Indiana, 47130

  • Clinical Research Solutions, P.C.

    Knoxville, Tennessee, 37920

  • Alliance Research Centers

    Laguna Hills, California, 92653

  • Adirondack Medical Center

    Lake Placid, New York, 12946

  • Sunrise Medical Research

    Lauderdale Lakes, Florida, 33319

  • North Pointe Psychiatry

    Lewisville, Texas, 75057

  • Baptist Health Medical Group

    Lexington, Kentucky, 40503

  • Pacific Clinical Studies, Inc

    Los Alamitos, California, 90720

  • Biomed Research Institute

    Miami, Florida, 33126

  • Miami Jewish Health Systems

    Miami, Florida, 33137

  • Florida International Research Center

    Miami, Florida, 33173

  • The Neurology Research Group, LLC

    Miami, Florida, 33176

  • L&C Professional Medical Research Institute

    Miami, Florida, 33186

  • Genoma Research Group, Inc.

    Miami, Florida, 66135

  • Empire Clinical Research

    Miami Lakes, Florida, 33018

  • Pyramid Clinical Research

    Monroe, New Jersey, 08831

  • Coastal Carolina Healthcare, P.A.

    New Bern, North Carolina, 28562

  • Coastal Connecticut Research, LLC

    New London, Connecticut, 06320

  • Mid Hudson Medical Research, PLLC

    New Windsor, New York, 12553

  • Heartland Research Associates

    Newton, Kansas, 67114

  • Lynn Health Science Institute

    Oklahoma City, Oklahoma, 73112

  • Medical Research Group of Central Florida

    Orange City, Florida, 32763

  • Combined Research Orlando Phase I-IV LLC

    Orlando, Florida, 32807

  • California Neurological Services, Inc.

    Panorama City, California, 91402

  • Havana Research Institute

    Pasadena, California, 91105

  • Thomas Jefferson University

    Philadelphia, Pennsylvania, 19107

  • Clinical Innovations, Inc.

    Riverside, California, 92506

  • Breakthrough Clinical Trials

    San Bernardino, California, 92408

  • HB Clinical Trials

    Santa Ana, California, 92704

  • Premier Clinical Research

    Spokane, Washington, 99202

  • Psych Care Consultants Research

    St Louis, Missouri, 63128

  • Suncoast Neuroscience Associates

    St. Petersburg, Florida, 33713

  • Stedman Clinical Trials

    Tampa, Florida, 33613

  • Ventura Clinical Trials

    Ventura, California, 93003

  • Asclepes Research Centers Florida

    Weeki Wachee, Florida, 34607

  • Family Practice Center of Wooster

    Wooster, Ohio, 44691

Other trials in United States

About this study

Official title: 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.

Being tested
Florbetapir F 18 PET Scan
Medical subject headings
Alzheimer Disease, Cognitive Dysfunction

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Florbetapir F 18 PET ScanDrug

    Also called LY3078786

    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.

Study groups in NCT02951598
Study groupRoleWhat they receive
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.
Receives: Drug: Florbetapir F 18 PET Scan
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.
Receives: Drug: Florbetapir F 18 PET Scan
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.
Receives: Drug: Florbetapir F 18 PET Scan
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.
Receives: Drug: Florbetapir F 18 PET Scan

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Mean Economic Cost Associated with Amyloid Positive AD

    Measured: Baseline through Study Completion (36 Months)

Secondary outcomes (12)

  1. Healthcare Resource Use by AD Cohort

    Measured: Baseline through Study Completion (36 Months)

  2. Mean Economic Cost by AD Cohort

    Measured: Baseline through 24 Months

  3. Bath Assessment of Subjective Quality of Life in Dementia (BASQID)

    Measured: Baseline, End of Study (36 Months)

  4. Mini-Mental State Examination (MMSE)

    Measured: Baseline, End of Study (36 Months)

  5. Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-Cog14)

    Measured: Baseline, End of Study (36 Months)

  6. Neuropsychiatric Inventory (NPI)

    Measured: Baseline, End of Study (36 Months)

  7. Functional Activities Questionnaire (FAQ)

    Measured: Baseline, End of Study (36 Months)

  8. Cognitive Function Inventory (CFI)

    Measured: Baseline, End of Study (36 Months)

  9. Zarit Burden Interview (ZBI)

    Measured: Baseline, End of Study (36 Months)

  10. Percentage of Participants with a Change in Living Situation

    Measured: 36 Months

  11. Time to Transition Across Stages of AD

    Measured: Baseline through Study Completion (36 Months)

  12. Desire to Institutionalize Scale (DTI)

    Measured: Baseline through Study Completion (36 Months)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Nov 2016 (estimated)
  2. Study start29 Oct 2016
  3. Primary completion30 Jan 2021
  4. Study completion28 Apr 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Enrolment
1,400 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02951598
Sponsor's protocol ID
16466
Other IDs
H8A-US-B004
Acronym
GERAS-US
Status last verified
Oct 2025
First submitted
28 Oct 2016
Last updated
24 Oct 2025
Results posted
No
Data monitoring committee
No
Individual data sharing
Yes: 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.

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.

    PubMed 31561360

Questions about this trial

What is this clinical trial studying?

An observational study of Alzheimer Disease and Mild Cognitive Impairment, run by Eli Lilly and Company at 77 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 24 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 77 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Mean Economic Cost Associated with Amyloid Positive AD (time frame: Baseline through Study Completion (36 Months)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02951598, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Oct 2025.

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