Skip to main content
OpenTrials
Active, Not Recruiting

NCT Number: NCT02951598

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Notify Me

Key information

Age range

55 year–85 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Advanced Research Center, Anaheim, California, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Other names: LY3078786

Primary outcomes

  1. Mean Economic Cost Associated with Amyloid Positive AD

    Time frame: Baseline through Study Completion (36 Months)

Secondary outcomes

  1. Healthcare Resource Use by AD Cohort

    Time frame: Baseline through Study Completion (36 Months)

  2. Mean Economic Cost by AD Cohort

    Time frame: Baseline through 24 Months

  3. Bath Assessment of Subjective Quality of Life in Dementia (BASQID)

    Time frame: Baseline, End of Study (36 Months)

  4. Mini-Mental State Examination (MMSE)

    Time frame: Baseline, End of Study (36 Months)

  5. Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-Cog14)

    Time frame: Baseline, End of Study (36 Months)

  6. Neuropsychiatric Inventory (NPI)

    Time frame: Baseline, End of Study (36 Months)

  7. Functional Activities Questionnaire (FAQ)

    Time frame: Baseline, End of Study (36 Months)

  8. Cognitive Function Inventory (CFI)

    Time frame: Baseline, End of Study (36 Months)

  9. Zarit Burden Interview (ZBI)

    Time frame: Baseline, End of Study (36 Months)

  10. Percentage of Participants with a Change in Living Situation

    Time frame: 36 Months

  11. Time to Transition Across Stages of AD

    Time frame: Baseline through Study Completion (36 Months)

  12. Desire to Institutionalize Scale (DTI)

    Time frame: Baseline through Study Completion (36 Months)

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Registry information

Official study 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)

Acronym: GERAS-US

Important dates

Study start
2016
Primary completion
2021
Study completion
2026
First posted
Nov 1, 2016
Registry last updated
Oct 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.