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

Sponsor
Eli Lilly and Company (Industry)
Overall Status
Active, not recruiting
CT.gov ID
NCT02951598
Collaborator
(none)
1,400
77
4
77.9
18.2
0.2

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Florbetapir F 18 PET Scan
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
1400 participants
Allocation:
Non-Randomized
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Health Services Research
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)
Actual Study Start Date :
Oct 29, 2016
Actual Primary Completion Date :
Jan 30, 2021
Anticipated Study Completion Date :
Apr 28, 2023

Arms and Interventions

Arm Intervention/Treatment
Other: 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
  • Other: 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
  • Other: 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
  • Other: 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
  • Outcome Measures

    Primary Outcome Measures

    1. Mean Economic Cost Associated with Amyloid Positive AD [Baseline through Study Completion (36 Months)]

    Secondary Outcome Measures

    1. Healthcare Resource Use by AD Cohort [Baseline through Study Completion (36 Months)]

    2. Mean Economic Cost by AD Cohort [Baseline through 24 Months]

    3. Bath Assessment of Subjective Quality of Life in Dementia (BASQID) [Baseline, End of Study (36 Months)]

    4. Mini-Mental State Examination (MMSE) [Baseline, End of Study (36 Months)]

    5. Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-Cog14) [Baseline, End of Study (36 Months)]

    6. Neuropsychiatric Inventory (NPI) [Baseline, End of Study (36 Months)]

    7. Functional Activities Questionnaire (FAQ) [Baseline, End of Study (36 Months)]

    8. Cognitive Function Inventory (CFI) [Baseline, End of Study (36 Months)]

    9. Zarit Burden Interview (ZBI) [Baseline, End of Study (36 Months)]

    10. Percentage of Participants with a Change in Living Situation [36 Months]

    11. Time to Transition Across Stages of AD [Baseline through Study Completion (36 Months)]

    12. Desire to Institutionalize Scale (DTI) [Baseline through Study Completion (36 Months)]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    55 Years to 85 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 California Pharmaceutical Research Institute Anaheim California United States 92804
    2 Advanced Research Center Anaheim California United States 92805
    3 Sun Valley Research Center Imperial California United States 92251
    4 Global Clinical Trials Irvine California United States 92614
    5 Irvine Clinical Research Center Irvine California United States 92614
    6 Alliance Research Centers Laguna Hills California United States 92653
    7 Pacific Clinical Studies, Inc Los Alamitos California United States 90720
    8 California Neurological Services, Inc. Panorama City California United States 91402
    9 Havana Research Institute Pasadena California United States 91105
    10 Clinical Innovations, Inc. Riverside California United States 92506
    11 Breakthrough Clinical Trials San Bernardino California United States 92408
    12 HB Clinical Trials Santa Ana California United States 92704
    13 Ventura Clinical Trials Ventura California United States 93003
    14 Colorado Neurological Institute Englewood Colorado United States 80113
    15 Coastal Connecticut Research, LLC New London Connecticut United States 06320
    16 JEM Research Institute Atlantis Florida United States 33462
    17 Visionary Investigators Network Aventura Florida United States 33180
    18 Research Alliance Clearwater Florida United States 33756
    19 Clinical Research of South Florida Coral Gables Florida United States 33134
    20 Infinite Clinical Research Doral Florida United States 33126
    21 International Research Partners, LLC. Doral Florida United States 33166
    22 Sarkis Clinical Trials Gainesville Florida United States 32607
    23 Indago Research & Health Center, Inc. Hialeah Florida United States 33012
    24 New Life Medical Research Center, Inc Hialeah Florida United States 33012
    25 Galiz Research Hialeah Florida United States 33016
    26 South Florida Clinical Trials Hialeah Florida United States 33016
    27 Van Buren Medical Hollywood Florida United States 33020
    28 Clinical Research of Homestead Homestead Florida United States 33030
    29 Jacksonville Center for Clinical Research Jacksonville Florida United States 32216
    30 Universal Neurological Care Jacksonville Florida United States 32216
    31 Sunrise Medical Research Lauderdale Lakes Florida United States 33319
    32 Empire Clinical Research Miami Lakes Florida United States 33018
    33 Biomed Research Institute Miami Florida United States 33126
    34 Miami Jewish Health Systems Miami Florida United States 33137
    35 Florida International Research Center Miami Florida United States 33173
    36 The Neurology Research Group, LLC Miami Florida United States 33176
    37 L&C Professional Medical Research Institute Miami Florida United States 33186
    38 Genoma Research Group, Inc. Miami Florida United States 66135
    39 Medical Research Group of Central Florida Orange City Florida United States 32763
    40 Combined Research Orlando Phase I-IV LLC Orlando Florida United States 32807
    41 Suncoast Neuroscience Associates Saint Petersburg Florida United States 33713
    42 Stedman Clinical Trials Tampa Florida United States 33613
    43 Asclepes Research Centers Florida Weeki Wachee Florida United States 34607
    44 Doctors Clinical Research Atlanta Georgia United States 30312
    45 American Health Network Franklin Indiana United States 46131
    46 American Research, LLC Jeffersonville Indiana United States 47130
    47 Heartland Research Associates Newton Kansas United States 67114
    48 Baptist Health Medical Group Lexington Kentucky United States 40503
    49 NeuroMedical Clinic of Central Louisiana Alexandria Louisiana United States 71301
    50 St. Agnes Medical Group Catonsville Maryland United States 21228
    51 Hattiesburg Clinic Hattiesburg Mississippi United States 39401
    52 University of Mississippi Medical Center Jackson Mississippi United States 39216
    53 Psych Care Consultants Research Saint Louis Missouri United States 63128
    54 Pyramid Clinical Research Monroe New Jersey United States 08831
    55 Healthwise Medical Associates, PC Brooklyn New York United States 11206
    56 Integrative Clinical Trials, LLC Brooklyn New York United States 11229
    57 Adirondack Medical Center Lake Placid New York United States 12946
    58 Mid Hudson Medical Research, PLLC New Windsor New York United States 12553
    59 Onsite Clinical Solutions, LLC Charlotte North Carolina United States 28203
    60 Onsite Clinical Solutions, LLC Charlotte North Carolina United States 28226
    61 Alzheimer's Memory Center Charlotte North Carolina United States 28270
    62 Coastal Carolina Healthcare, P.A. New Bern North Carolina United States 28562
    63 Dayton Center for Neurological Disorders Centerville Ohio United States 45459
    64 Christ Hospital Cincinnati Ohio United States 45219
    65 Family Practice Center of Wooster Wooster Ohio United States 44691
    66 Lynn Health Science Institute Oklahoma City Oklahoma United States 73112
    67 Thomas Jefferson University Philadelphia Pennsylvania United States 19107
    68 Wesley Neurology Clinic Cordova Tennessee United States 38018
    69 Clinical Research Solutions, P.C. Knoxville Tennessee United States 37920
    70 Lakeside Life Center Carrollton Texas United States 75010
    71 Univ Of Texas Southwestern at Dallas Childrens Med Ctr Dallas Texas United States 75390
    72 The Clinical Research Group Frisco Texas United States 75035
    73 Dallas Clinical Research Greenville Texas United States 75401
    74 Highlands Medical Associates, P.A. Highlands Texas United States 77562
    75 University Hills Clinical Research Irving Texas United States 75062
    76 North Pointe Psychiatry Lewisville Texas United States 75057
    77 Premier Clinical Research Spokane Washington United States 99202

    Sponsors and Collaborators

    • 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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Eli Lilly and Company
    ClinicalTrials.gov Identifier:
    NCT02951598
    Other Study ID Numbers:
    • 16466
    • H8A-US-B004
    First Posted:
    Nov 1, 2016
    Last Update Posted:
    Jun 10, 2021
    Last Verified:
    Jun 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Jun 10, 2021