A Study of Health Care Use and Costs in Participants With Early Stage Alzheimer's Disease (AD)
NCT ID: NCT02951598
Last Updated: 2025-10-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
1400 participants
OBSERVATIONAL
2016-10-29
2026-04-28
Brief Summary
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Detailed Description
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Conditions
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Study Groups
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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.
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.
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.
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.
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.
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.
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.
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.
Interventions
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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 Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 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.
55 Years
85 Years
ALL
No
Sponsors
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Eli Lilly and Company
INDUSTRY
Responsible Party
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Principal Investigators
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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)
Role: STUDY_DIRECTOR
Eli Lilly and Company
Locations
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California Pharmaceutical Research Institute
Anaheim, California, United States
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
South Florida Clinical Trials
Hialeah, Florida, United States
Van Buren Medical
Hollywood, Florida, United States
Clinical Research of Homestead
Homestead, Florida, United States
Jacksonville Center for Clinical Research
Jacksonville, Florida, United States
Universal Neurological Care
Jacksonville, Florida, United States
Sunrise Medical Research
Lauderdale Lakes, Florida, United States
Biomed Research Institute
Miami, Florida, United States
Miami Jewish Health Systems
Miami, Florida, United States
Florida International Research Center
Miami, Florida, United States
The Neurology Research Group, LLC
Miami, Florida, United States
L&C Professional Medical Research Institute
Miami, Florida, United States
Genoma Research Group, Inc.
Miami, Florida, United States
Empire Clinical Research
Miami Lakes, Florida, United States
Medical Research Group of Central Florida
Orange City, Florida, United States
Combined Research Orlando Phase I-IV LLC
Orlando, Florida, United States
Suncoast Neuroscience Associates
St. Petersburg, Florida, United States
Stedman Clinical Trials
Tampa, Florida, United States
Asclepes Research Centers Florida
Weeki Wachee, Florida, United States
Doctors Clinical Research
Atlanta, Georgia, United States
American Health Network
Franklin, Indiana, United States
American Research, LLC
Jeffersonville, Indiana, United States
Heartland Research Associates
Newton, Kansas, United States
Baptist Health Medical Group
Lexington, Kentucky, United States
NeuroMedical Clinic of Central Louisiana
Alexandria, Louisiana, United States
St. Agnes Medical Group
Catonsville, Maryland, United States
Hattiesburg Clinic
Hattiesburg, Mississippi, United States
University of Mississippi Medical Center
Jackson, Mississippi, United States
Psych Care Consultants Research
St Louis, Missouri, United States
Pyramid Clinical Research
Monroe, New Jersey, United States
Healthwise Medical Associates, PC
Brooklyn, New York, United States
Integrative Clinical Trials, LLC
Brooklyn, New York, United States
Adirondack Medical Center
Lake Placid, New York, United States
Mid Hudson Medical Research, PLLC
New Windsor, New York, United States
Onsite Clinical Solutions, LLC
Charlotte, North Carolina, United States
Onsite Clinical Solutions, LLC
Charlotte, North Carolina, United States
Alzheimer's Memory Center
Charlotte, North Carolina, United States
Coastal Carolina Healthcare, P.A.
New Bern, North Carolina, United States
Dayton Center for Neurological Disorders
Centerville, Ohio, United States
Christ Hospital
Cincinnati, Ohio, United States
Family Practice Center of Wooster
Wooster, Ohio, United States
Lynn Health Science Institute
Oklahoma City, Oklahoma, United States
Thomas Jefferson University
Philadelphia, Pennsylvania, United States
Wesley Neurology Clinic
Cordova, Tennessee, United States
Clinical Research Solutions, P.C.
Knoxville, Tennessee, United States
Lakeside Life Center
Carrollton, Texas, United States
Univ Of Texas Southwestern at Dallas Childrens Med Ctr
Dallas, Texas, United States
The Clinical Research Group
Frisco, Texas, United States
Dallas Clinical Research
Greenville, Texas, United States
Highlands Medical Associates, P.A.
Highlands, Texas, United States
University Hills Clinical Research
Irving, Texas, United States
North Pointe Psychiatry
Lewisville, Texas, United States
Premier Clinical Research
Spokane, Washington, United States
Countries
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References
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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.
Other Identifiers
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H8A-US-B004
Identifier Type: OTHER
Identifier Source: secondary_id
16466
Identifier Type: -
Identifier Source: org_study_id
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