Not provided
Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| H8A-US-B004 | Other Identifier | Eli Lilly and Company |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
| |
| 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. |
| |
| 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. |
| |
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Florbetapir F 18 PET Scan | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Economic Cost Associated with Amyloid Positive AD | Baseline through Study Completion (36 Months) |
| Measure | Description | 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) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| 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 Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| California Pharmaceutical Research Institute | Anaheim | California | 92804 | United States | ||
| Advanced Research Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31561360 | Derived | 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. |
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
|
|
| 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) |
| Anaheim |
| California |
| 92805 |
| United States |
| Sun Valley Research Center | Imperial | California | 92251 | United States |
| Global Clinical Trials | Irvine | California | 92614 | United States |
| Irvine Clinical Research Center | Irvine | California | 92614 | United States |
| Alliance Research Centers | Laguna Hills | California | 92653 | United States |
| Pacific Clinical Studies, Inc | Los Alamitos | California | 90720 | United States |
| California Neurological Services, Inc. | Panorama City | California | 91402 | United States |
| Havana Research Institute | Pasadena | California | 91105 | United States |
| Clinical Innovations, Inc. | Riverside | California | 92506 | United States |
| Breakthrough Clinical Trials | San Bernardino | California | 92408 | United States |
| HB Clinical Trials | Santa Ana | California | 92704 | United States |
| Ventura Clinical Trials | Ventura | California | 93003 | United States |
| Colorado Neurological Institute | Englewood | Colorado | 80113 | United States |
| Coastal Connecticut Research, LLC | New London | Connecticut | 06320 | United States |
| JEM Research Institute | Atlantis | Florida | 33462 | United States |
| Visionary Investigators Network | Aventura | Florida | 33180 | United States |
| Research Alliance | Clearwater | Florida | 33756 | United States |
| Clinical Research of South Florida | Coral Gables | Florida | 33134 | United States |
| Infinite Clinical Research | Doral | Florida | 33126 | United States |
| International Research Partners, LLC. | Doral | Florida | 33166 | United States |
| Sarkis Clinical Trials | Gainesville | Florida | 32607 | United States |
| Indago Research & Health Center, Inc. | Hialeah | Florida | 33012 | United States |
| New Life Medical Research Center, Inc | Hialeah | Florida | 33012 | United States |
| Galiz Research | Hialeah | Florida | 33016 | United States |
| South Florida Clinical Trials | Hialeah | Florida | 33016 | United States |
| Van Buren Medical | Hollywood | Florida | 33020 | United States |
| Clinical Research of Homestead | Homestead | Florida | 33030 | United States |
| Jacksonville Center for Clinical Research | Jacksonville | Florida | 32216 | United States |
| Universal Neurological Care | Jacksonville | Florida | 32216 | United States |
| Sunrise Medical Research | Lauderdale Lakes | Florida | 33319 | United States |
| Biomed Research Institute | Miami | Florida | 33126 | United States |
| Miami Jewish Health Systems | Miami | Florida | 33137 | United States |
| Florida International Research Center | Miami | Florida | 33173 | United States |
| The Neurology Research Group, LLC | Miami | Florida | 33176 | United States |
| L&C Professional Medical Research Institute | Miami | Florida | 33186 | United States |
| Genoma Research Group, Inc. | Miami | Florida | 66135 | United States |
| Empire Clinical Research | Miami Lakes | Florida | 33018 | United States |
| Medical Research Group of Central Florida | Orange City | Florida | 32763 | United States |
| Combined Research Orlando Phase I-IV LLC | Orlando | Florida | 32807 | United States |
| Suncoast Neuroscience Associates | St. Petersburg | Florida | 33713 | United States |
| Stedman Clinical Trials | Tampa | Florida | 33613 | United States |
| Asclepes Research Centers Florida | Weeki Wachee | Florida | 34607 | United States |
| Doctors Clinical Research | Atlanta | Georgia | 30312 | United States |
| American Health Network | Franklin | Indiana | 46131 | United States |
| American Research, LLC | Jeffersonville | Indiana | 47130 | United States |
| Heartland Research Associates | Newton | Kansas | 67114 | United States |
| Baptist Health Medical Group | Lexington | Kentucky | 40503 | United States |
| NeuroMedical Clinic of Central Louisiana | Alexandria | Louisiana | 71301 | United States |
| St. Agnes Medical Group | Catonsville | Maryland | 21228 | United States |
| Hattiesburg Clinic | Hattiesburg | Mississippi | 39401 | United States |
| University of Mississippi Medical Center | Jackson | Mississippi | 39216 | United States |
| Psych Care Consultants Research | St Louis | Missouri | 63128 | United States |
| Pyramid Clinical Research | Monroe | New Jersey | 08831 | United States |
| Healthwise Medical Associates, PC | Brooklyn | New York | 11206 | United States |
| Integrative Clinical Trials, LLC | Brooklyn | New York | 11229 | United States |
| Adirondack Medical Center | Lake Placid | New York | 12946 | United States |
| Mid Hudson Medical Research, PLLC | New Windsor | New York | 12553 | United States |
| Onsite Clinical Solutions, LLC | Charlotte | North Carolina | 28203 | United States |
| Onsite Clinical Solutions, LLC | Charlotte | North Carolina | 28226 | United States |
| Alzheimer's Memory Center | Charlotte | North Carolina | 28270 | United States |
| Coastal Carolina Healthcare, P.A. | New Bern | North Carolina | 28562 | United States |
| Dayton Center for Neurological Disorders | Centerville | Ohio | 45459 | United States |
| Christ Hospital | Cincinnati | Ohio | 45219 | United States |
| Family Practice Center of Wooster | Wooster | Ohio | 44691 | United States |
| Lynn Health Science Institute | Oklahoma City | Oklahoma | 73112 | United States |
| Thomas Jefferson University | Philadelphia | Pennsylvania | 19107 | United States |
| Wesley Neurology Clinic | Cordova | Tennessee | 38018 | United States |
| Clinical Research Solutions, P.C. | Knoxville | Tennessee | 37920 | United States |
| Lakeside Life Center | Carrollton | Texas | 75010 | United States |
| Univ Of Texas Southwestern at Dallas Childrens Med Ctr | Dallas | Texas | 75390 | United States |
| The Clinical Research Group | Frisco | Texas | 75035 | United States |
| Dallas Clinical Research | Greenville | Texas | 75401 | United States |
| Highlands Medical Associates, P.A. | Highlands | Texas | 77562 | United States |
| University Hills Clinical Research | Irving | Texas | 75062 | United States |
| North Pointe Psychiatry | Lewisville | Texas | 75057 | United States |
| Premier Clinical Research | Spokane | Washington | 99202 | United States |
| ID | Term |
|---|---|
| D000544 | Alzheimer Disease |
| D060825 | Cognitive Dysfunction |
| ID | Term |
|---|---|
| D003704 | Dementia |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D024801 | Tauopathies |
| D019636 | Neurodegenerative Diseases |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| D003072 | Cognition Disorders |
Not provided
Not provided