A Study of Health Care Use and Costs in Participants With Early Stage Alzheimer's Disease (AD)
- Conditions
- Mild Cognitive ImpairmentAlzheimer Disease
- Interventions
- Drug: Florbetapir F 18 PET Scan
- Registration Number
- NCT02951598
- Lead Sponsor
- Eli Lilly and Company
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 1400
- 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.
- 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.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description MCI (Amyloid Negative) Florbetapir F 18 PET Scan Participants with MCI who tested amyloid negative. These participants were not eligible to participate in the 36 month prospective portion of the study. MCI (Amyloid Positive) Florbetapir F 18 PET Scan 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) Florbetapir F 18 PET Scan 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. Mild Dementia (Amyloid Negative) Florbetapir F 18 PET Scan Participants with mild dementia who tested amyloid negative. These participants were not eligible to participate in the 36 month prospective portion of the study.
- Primary Outcome Measures
Name Time Method Mean Economic Cost Associated with Amyloid Positive AD Baseline through Study Completion (36 Months)
- Secondary Outcome Measures
Name Time Method Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-Cog14) Baseline, End of Study (36 Months) Time to Transition Across Stages of AD Baseline through Study Completion (36 Months) Healthcare Resource Use by AD Cohort Baseline through Study Completion (36 Months) Mean Economic Cost by AD Cohort Baseline through 24 Months Mini-Mental State Examination (MMSE) Baseline, End of Study (36 Months) Neuropsychiatric Inventory (NPI) Baseline, End of Study (36 Months) Bath Assessment of Subjective Quality of Life in Dementia (BASQID) 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) Percentage of Participants with a Change in Living Situation 36 Months Zarit Burden Interview (ZBI) Baseline, End of Study (36 Months) Desire to Institutionalize Scale (DTI) Baseline through Study Completion (36 Months)
Trial Locations
- Locations (76)
Global Clinical Trials
🇺🇸Irvine, California, United States
Irvine Clinical Research Center
🇺🇸Irvine, California, United States
Colorado Neurological Institute
🇺🇸Englewood, Colorado, United States
Clinical Research of South Florida
🇺🇸Coral Gables, Florida, United States
Advanced Research Center
🇺🇸Anaheim, California, United States
Research Alliance
🇺🇸Clearwater, Florida, United States
Visionary Investigators Network
🇺🇸Aventura, Florida, United States
Jacksonville Center for Clinical Research
🇺🇸Jacksonville, Florida, United States
American Research, LLC
🇺🇸Jeffersonville, Indiana, United States
HB Clinical Trials
🇺🇸Santa Ana, California, United States
South Florida Clinical Trials
🇺🇸Hialeah, Florida, United States
California Neurological Services, Inc.
🇺🇸Panorama City, California, United States
Onsite Clinical Solutions, LLC
🇺🇸Charlotte, North Carolina, United States
Breakthrough Clinical Trials
🇺🇸San Bernardino, California, United States
Coastal Connecticut Research, LLC
🇺🇸New London, Connecticut, United States
Infinite Clinical Research
🇺🇸Doral, Florida, United States
International Research Partners, LLC.
🇺🇸Doral, Florida, United States
Clinical Research of Homestead
🇺🇸Homestead, Florida, United States
Van Buren Medical
🇺🇸Hollywood, Florida, United States
Doctors Clinical Research
🇺🇸Atlanta, Georgia, United States
American Health Network
🇺🇸Franklin, Indiana, United States
NeuroMedical Clinic of Central Louisiana
🇺🇸Alexandria, Louisiana, United States
Medical Research Group of Central Florida
🇺🇸Orange City, Florida, United States
Wesley Neurology Clinic
🇺🇸Cordova, Tennessee, United States
Pyramid Clinical Research
🇺🇸Monroe, New Jersey, United States
Hattiesburg Clinic
🇺🇸Hattiesburg, Mississippi, United States
North Pointe Psychiatry
🇺🇸Lewisville, Texas, United States
Highlands Medical Associates, P.A.
🇺🇸Highlands, Texas, United States
Clinical Research Solutions, P.C.
🇺🇸Knoxville, Tennessee, United States
Healthwise Medical Associates, PC
🇺🇸Brooklyn, New York, United States
Premier Clinical Research
🇺🇸Spokane, Washington, United States
Dayton Center for Neurological Disorders
🇺🇸Centerville, Ohio, United States
Family Practice Center of Wooster
🇺🇸Wooster, Ohio, United States
Dallas Clinical Research
🇺🇸Greenville, Texas, United States
Heartland Research Associates
🇺🇸Newton, Kansas, United States
Genoma Research Group, Inc.
🇺🇸Miami, Florida, United States
Lynn Health Science Institute
🇺🇸Oklahoma City, Oklahoma, United States
Biomed Research Institute
🇺🇸Miami, Florida, United States
Miami Jewish Health Systems
🇺🇸Miami, Florida, United States
The Neurology Research Group, LLC
🇺🇸Miami, Florida, United States
L&C Professional Medical Research Institute
🇺🇸Miami, Florida, United States
Christ Hospital
🇺🇸Cincinnati, Ohio, United States
Alzheimer's Memory Center
🇺🇸Charlotte, North Carolina, United States
Indago Research & Health Center, Inc.
🇺🇸Hialeah, Florida, United States
Florida International Research Center
🇺🇸Miami, Florida, United States
Suncoast Neuroscience Associates
🇺🇸Saint Petersburg, Florida, United States
University of Mississippi Medical Center
🇺🇸Jackson, Mississippi, United States
Havana Research Institute
🇺🇸Pasadena, California, United States
Pacific Clinical Studies, Inc
🇺🇸Los Alamitos, California, United States
Clinical Innovations, Inc.
🇺🇸Riverside, California, United States
Alliance Research Centers
🇺🇸Laguna Hills, California, United States
California Pharmaceutical Research Institute
🇺🇸Anaheim, California, United States
Ventura Clinical Trials
🇺🇸Ventura, California, United States
New Life Medical Research Center, Inc
🇺🇸Hialeah, Florida, United States
Galiz Research
🇺🇸Hialeah, Florida, United States
Empire Clinical Research
🇺🇸Miami Lakes, Florida, United States
Universal Neurological Care
🇺🇸Jacksonville, Florida, United States
Sunrise Medical Research
🇺🇸Lauderdale Lakes, Florida, United States
Asclepes Research Centers Florida
🇺🇸Weeki Wachee, Florida, United States
Psych Care Consultants Research
🇺🇸Saint Louis, Missouri, United States
Adirondack Medical Center
🇺🇸Lake Placid, New York, United States
Integrative Clinical Trials, LLC
🇺🇸Brooklyn, New York, United States
University Hills Clinical Research
🇺🇸Irving, Texas, United States
Univ Of Texas Southwestern at Dallas Childrens Med Ctr
🇺🇸Dallas, Texas, United States
Sun Valley Research Center
🇺🇸Imperial, California, United States
JEM Research Institute
🇺🇸Atlantis, Florida, United States
Coastal Carolina Healthcare, P.A.
🇺🇸New Bern, North Carolina, United States
The Clinical Research Group
🇺🇸Frisco, Texas, United States
Lakeside Life Center
🇺🇸Carrollton, Texas, United States
Combined Research Orlando Phase I-IV LLC
🇺🇸Orlando, Florida, United States
Stedman Clinical Trials
🇺🇸Tampa, Florida, United States
Sarkis Clinical Trials
🇺🇸Gainesville, Florida, United States
Baptist Health Medical Group
🇺🇸Lexington, Kentucky, United States
Mid Hudson Medical Research, PLLC
🇺🇸New Windsor, New York, United States
St. Agnes Medical Group
🇺🇸Catonsville, Maryland, United States
Thomas Jefferson University
🇺🇸Philadelphia, Pennsylvania, United States