Clinical trial NCT02951598: A Study of Health Care Use and Costs in Participants With Early Stage Alzheimer's Disease (AD)
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)
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Alzheimer Disease
Mild Cognitive Impairment
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2016-11-01
Enrollment: 1400
Sex: ALL
Minimum age (years): 55
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no

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.


Eligibility 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.

Primary outcomes:
measure: Mean Economic Cost Associated with Amyloid Positive AD
timeFrame: Baseline through Study Completion (36 Months)
Secondary outcomes:
measure: Healthcare Resource Use by AD Cohort
timeFrame: Baseline through Study Completion (36 Months)
measure: Mean Economic Cost by AD Cohort
timeFrame: Baseline through 24 Months
measure: Bath Assessment of Subjective Quality of Life in Dementia (BASQID)
timeFrame: Baseline, End of Study (36 Months)
measure: Mini-Mental State Examination (MMSE)
timeFrame: Baseline, End of Study (36 Months)
measure: Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-Cog14)
timeFrame: Baseline, End of Study (36 Months)
measure: Neuropsychiatric Inventory (NPI)
timeFrame: Baseline, End of Study (36 Months)
measure: Functional Activities Questionnaire (FAQ)
timeFrame: Baseline, End of Study (36 Months)
measure: Cognitive Function Inventory (CFI)
timeFrame: Baseline, End of Study (36 Months)
measure: Zarit Burden Interview (ZBI)
timeFrame: Baseline, End of Study (36 Months)
measure: Percentage of Participants with a Change in Living Situation
timeFrame: 36 Months
measure: Time to Transition Across Stages of AD
timeFrame: Baseline through Study Completion (36 Months)
measure: Desire to Institutionalize Scale (DTI)
timeFrame: Baseline through Study Completion (36 Months)
Other outcomes:
Locations:
city: Anaheim
country: United States
facility: California Pharmaceutical Research Institute
state: California
city: Anaheim
country: United States
facility: Advanced Research Center
state: California
city: Imperial
country: United States
facility: Sun Valley Research Center
state: California
city: Irvine
country: United States
facility: Global Clinical Trials
state: California
city: Irvine
country: United States
facility: Irvine Clinical Research Center
state: California
city: Laguna Hills
country: United States
facility: Alliance Research Centers
state: California
city: Los Alamitos
country: United States
facility: Pacific Clinical Studies, Inc
state: California
city: Panorama City
country: United States
facility: California Neurological Services, Inc.
state: California
city: Pasadena
country: United States
facility: Havana Research Institute
state: California
city: Riverside
country: United States
facility: Clinical Innovations, Inc.
state: California
city: San Bernardino
country: United States
facility: Breakthrough Clinical Trials
state: California
city: Santa Ana
country: United States
facility: HB Clinical Trials
state: California
city: Ventura
country: United States
facility: Ventura Clinical Trials
state: California
city: Englewood
country: United States
facility: Colorado Neurological Institute
state: Colorado
city: New London
country: United States
facility: Coastal Connecticut Research, LLC
state: Connecticut
city: Atlantis
country: United States
facility: JEM Research Institute
state: Florida
city: Aventura
country: United States
facility: Visionary Investigators Network
state: Florida
city: Clearwater
country: United States
facility: Research Alliance
state: Florida
city: Coral Gables
country: United States
facility: Clinical Research of South Florida
state: Florida
city: Doral
country: United States
facility: Infinite Clinical Research
state: Florida
city: Doral
country: United States
facility: International Research Partners, LLC.
state: Florida
city: Gainesville
country: United States
facility: Sarkis Clinical Trials
state: Florida
city: Hialeah
country: United States
facility: Indago Research & Health Center, Inc.
state: Florida
city: Hialeah
country: United States
facility: New Life Medical Research Center, Inc
state: Florida
city: Hialeah
country: United States
facility: Galiz Research
state: Florida
city: Hialeah
country: United States
facility: South Florida Clinical Trials
state: Florida
city: Hollywood
country: United States
facility: Van Buren Medical
state: Florida
city: Homestead
country: United States
facility: Clinical Research of Homestead
state: Florida
city: Jacksonville
country: United States
facility: Jacksonville Center for Clinical Research
state: Florida
city: Jacksonville
country: United States
facility: Universal Neurological Care
state: Florida
city: Lauderdale Lakes
country: United States
facility: Sunrise Medical Research
state: Florida
city: Miami Lakes
country: United States
facility: Empire Clinical Research
state: Florida
city: Miami
country: United States
facility: Biomed Research Institute
state: Florida
city: Miami
country: United States
facility: Miami Jewish Health Systems
state: Florida
city: Miami
country: United States
facility: Florida International Research Center
state: Florida
city: Miami
country: United States
facility: The Neurology Research Group, LLC
state: Florida
city: Miami
country: United States
facility: L&C Professional Medical Research Institute
state: Florida
city: Miami
country: United States
facility: Genoma Research Group, Inc.
state: Florida
city: Orange City
country: United States
facility: Medical Research Group of Central Florida
state: Florida
city: Orlando
country: United States
facility: Combined Research Orlando Phase I-IV LLC
state: Florida
city: Saint Petersburg
country: United States
facility: Suncoast Neuroscience Associates
state: Florida
city: Tampa
country: United States
facility: Stedman Clinical Trials
state: Florida
city: Weeki Wachee
country: United States
facility: Asclepes Research Centers Florida
state: Florida
city: Atlanta
country: United States
facility: Doctors Clinical Research
state: Georgia
city: Franklin
country: United States
facility: American Health Network
state: Indiana
city: Jeffersonville
country: United States
facility: American Research, LLC
state: Indiana
city: Newton
country: United States
facility: Heartland Research Associates
state: Kansas
city: Lexington
country: United States
facility: Baptist Health Medical Group
state: Kentucky
city: Alexandria
country: United States
facility: NeuroMedical Clinic of Central Louisiana
state: Louisiana
city: Catonsville
country: United States
facility: St. Agnes Medical Group
state: Maryland
city: Hattiesburg
country: United States
facility: Hattiesburg Clinic
state: Mississippi
city: Jackson
country: United States
facility: University of Mississippi Medical Center
state: Mississippi
city: Saint Louis
country: United States
facility: Psych Care Consultants Research
state: Missouri
city: Monroe
country: United States
facility: Pyramid Clinical Research
state: New Jersey
city: Brooklyn
country: United States
facility: Healthwise Medical Associates, PC
state: New York
city: Brooklyn
country: United States
facility: Integrative Clinical Trials, LLC
state: New York
city: Lake Placid
country: United States
facility: Adirondack Medical Center
state: New York
city: New Windsor
country: United States
facility: Mid Hudson Medical Research, PLLC
state: New York
city: Charlotte
country: United States
facility: Onsite Clinical Solutions, LLC
state: North Carolina
city: Charlotte
country: United States
facility: Onsite Clinical Solutions, LLC
state: North Carolina
city: Charlotte
country: United States
facility: Alzheimer's Memory Center
state: North Carolina
city: New Bern
country: United States
facility: Coastal Carolina Healthcare, P.A.
state: North Carolina
city: Centerville
country: United States
facility: Dayton Center for Neurological Disorders
state: Ohio
city: Cincinnati
country: United States
facility: Christ Hospital
state: Ohio
city: Wooster
country: United States
facility: Family Practice Center of Wooster
state: Ohio
city: Oklahoma City
country: United States
facility: Lynn Health Science Institute
state: Oklahoma
city: Philadelphia
country: United States
facility: Thomas Jefferson University
state: Pennsylvania
city: Cordova
country: United States
facility: Wesley Neurology Clinic
state: Tennessee
city: Knoxville
country: United States
facility: Clinical Research Solutions, P.C.
state: Tennessee
city: Carrollton
country: United States
facility: Lakeside Life Center
state: Texas
city: Dallas
country: United States
facility: Univ Of Texas Southwestern at Dallas Childrens Med Ctr
state: Texas
city: Frisco
country: United States
facility: The Clinical Research Group
state: Texas
city: Greenville
country: United States
facility: Dallas Clinical Research
state: Texas
city: Highlands
country: United States
facility: Highlands Medical Associates, P.A.
state: Texas
city: Irving
country: United States
facility: University Hills Clinical Research
state: Texas
city: Lewisville
country: United States
facility: North Pointe Psychiatry
state: Texas
city: Spokane
country: United States
facility: Premier Clinical Research
state: Washington
Study officials:
affiliation: Eli Lilly and Company
name: 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)
role: STUDY_DIRECTOR
References:
citation: 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.