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

Alzheimer Disease Clinical Trial

— GERAS-US  

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)

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02951598
• Other study ID #: 16466
• Secondary ID: H8A-US-B004
• Status: Active, not recruiting
• Start date: October 29, 2016
• Est. completion date: April 28, 2026

Study information

• Verified date: October 2023
• Source: Eli Lilly and Company
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 1400
• Est. completion date: April 28, 2026
• Est. primary completion date: January 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 55 Years to 85 Years

Eligibility

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.

Related Conditions & MeSH terms

• Alzheimer Disease
• Cognitive Dysfunction
• Mild Cognitive Impairment

Intervention

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.

Locations

Country	Name	City	State
United States	NeuroMedical Clinic of Central Louisiana	Alexandria	Louisiana
United States	Advanced Research Center	Anaheim	California
United States	California Pharmaceutical Research Institute	Anaheim	California
United States	Doctors Clinical Research	Atlanta	Georgia
United States	JEM Research Institute	Atlantis	Florida
United States	Visionary Investigators Network	Aventura	Florida
United States	Healthwise Medical Associates, PC	Brooklyn	New York
United States	Integrative Clinical Trials, LLC	Brooklyn	New York
United States	Lakeside Life Center	Carrollton	Texas
United States	St. Agnes Medical Group	Catonsville	Maryland
United States	Dayton Center for Neurological Disorders	Centerville	Ohio
United States	Alzheimer's Memory Center	Charlotte	North Carolina
United States	Onsite Clinical Solutions, LLC	Charlotte	North Carolina
United States	Onsite Clinical Solutions, LLC	Charlotte	North Carolina
United States	Christ Hospital	Cincinnati	Ohio
United States	Research Alliance	Clearwater	Florida
United States	Clinical Research of South Florida	Coral Gables	Florida
United States	Wesley Neurology Clinic	Cordova	Tennessee
United States	Univ Of Texas Southwestern at Dallas Childrens Med Ctr	Dallas	Texas
United States	Infinite Clinical Research	Doral	Florida
United States	International Research Partners, LLC.	Doral	Florida
United States	Colorado Neurological Institute	Englewood	Colorado
United States	American Health Network	Franklin	Indiana
United States	The Clinical Research Group	Frisco	Texas
United States	Sarkis Clinical Trials	Gainesville	Florida
United States	Dallas Clinical Research	Greenville	Texas
United States	Hattiesburg Clinic	Hattiesburg	Mississippi
United States	Galiz Research	Hialeah	Florida
United States	Indago Research & Health Center, Inc.	Hialeah	Florida
United States	New Life Medical Research Center, Inc	Hialeah	Florida
United States	South Florida Clinical Trials	Hialeah	Florida
United States	Highlands Medical Associates, P.A.	Highlands	Texas
United States	Van Buren Medical	Hollywood	Florida
United States	Clinical Research of Homestead	Homestead	Florida
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	University Hills Clinical Research	Irving	Texas
United States	University of Mississippi Medical Center	Jackson	Mississippi
United States	Jacksonville Center for Clinical Research	Jacksonville	Florida
United States	Universal Neurological Care	Jacksonville	Florida
United States	American Research, LLC	Jeffersonville	Indiana
United States	Clinical Research Solutions, P.C.	Knoxville	Tennessee
United States	Alliance Research Centers	Laguna Hills	California
United States	Adirondack Medical Center	Lake Placid	New York
United States	Sunrise Medical Research	Lauderdale Lakes	Florida
United States	North Pointe Psychiatry	Lewisville	Texas
United States	Baptist Health Medical Group	Lexington	Kentucky
United States	Pacific Clinical Studies, Inc	Los Alamitos	California
United States	Biomed Research Institute	Miami	Florida
United States	Florida International Research Center	Miami	Florida
United States	Genoma Research Group, Inc.	Miami	Florida
United States	L&C Professional Medical Research Institute	Miami	Florida
United States	Miami Jewish Health Systems	Miami	Florida
United States	The Neurology Research Group, LLC	Miami	Florida
United States	Empire Clinical Research	Miami Lakes	Florida
United States	Pyramid Clinical Research	Monroe	New Jersey
United States	Coastal Carolina Healthcare, P.A.	New Bern	North Carolina
United States	Coastal Connecticut Research, LLC	New London	Connecticut
United States	Mid Hudson Medical Research, PLLC	New Windsor	New York
United States	Heartland Research Associates	Newton	Kansas
United States	Lynn Health Science Institute	Oklahoma City	Oklahoma
United States	Medical Research Group of Central Florida	Orange City	Florida
United States	Combined Research Orlando Phase I-IV LLC	Orlando	Florida
United States	California Neurological Services, Inc.	Panorama City	California
United States	Havana Research Institute	Pasadena	California
United States	Thomas Jefferson University	Philadelphia	Pennsylvania
United States	Clinical Innovations, Inc.	Riverside	California
United States	Psych Care Consultants Research	Saint Louis	Missouri
United States	Suncoast Neuroscience Associates	Saint Petersburg	Florida
United States	Breakthrough Clinical Trials	San Bernardino	California
United States	HB Clinical Trials	Santa Ana	California
United States	Premier Clinical Research	Spokane	Washington
United States	Stedman Clinical Trials	Tampa	Florida
United States	Ventura Clinical Trials	Ventura	California
United States	Asclepes Research Centers Florida	Weeki Wachee	Florida
United States	Family Practice Center of Wooster	Wooster	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Eli Lilly and Company

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean Economic Cost Associated with Amyloid Positive AD		Baseline through Study Completion (36 Months)
Secondary	Healthcare Resource Use by AD Cohort		Baseline through Study Completion (36 Months)
Secondary	Mean Economic Cost by AD Cohort		Baseline through 24 Months
Secondary	Bath Assessment of Subjective Quality of Life in Dementia (BASQID)		Baseline, End of Study (36 Months)
Secondary	Mini-Mental State Examination (MMSE)		Baseline, End of Study (36 Months)
Secondary	Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-Cog14)		Baseline, End of Study (36 Months)
Secondary	Neuropsychiatric Inventory (NPI)		Baseline, End of Study (36 Months)
Secondary	Functional Activities Questionnaire (FAQ)		Baseline, End of Study (36 Months)
Secondary	Cognitive Function Inventory (CFI)		Baseline, End of Study (36 Months)
Secondary	Zarit Burden Interview (ZBI)		Baseline, End of Study (36 Months)
Secondary	Percentage of Participants with a Change in Living Situation		36 Months
Secondary	Time to Transition Across Stages of AD		Baseline through Study Completion (36 Months)
Secondary	Desire to Institutionalize Scale (DTI)		Baseline through Study Completion (36 Months)