GERAS-US: A Study of Health Care Use and Costs in Participants With Early Stage Alzheimer's Disease (AD)
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 |
---|---|---|
|
N/A |
Study Design
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:
|
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:
|
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:
|
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:
|
Outcome Measures
Primary Outcome Measures
- Mean Economic Cost Associated with Amyloid Positive AD [Baseline through Study Completion (36 Months)]
Secondary Outcome Measures
- 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)]
Eligibility Criteria
Criteria
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.- 16466
- H8A-US-B004