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

Primary Purpose

Alzheimer Disease, Mild Cognitive Impairment

Status

Active

Phase

Locations

United States

Study Type

Observational

Intervention

Florbetapir F 18 PET Scan

About this trial

This is an observational trial for Alzheimer Disease

Eligibility Criteria

55 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Arm Label

MCI (Amyloid Positive)

Mild AD Dementia (Amyloid Positive)

MCI (Amyloid Negative)

Mild Dementia (Amyloid Negative)

Arm Description

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.

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.

Participants with MCI who tested amyloid negative. These participants were not eligible to participate in the 36 month prospective portion of the study.

Participants with mild dementia who tested amyloid negative. These participants were not eligible to participate in the 36 month prospective portion of the study.

Outcomes

Primary Outcome Measures

Mean Economic Cost Associated with Amyloid Positive AD

Secondary Outcome Measures

Healthcare Resource Use by AD Cohort

Mean Economic Cost by AD Cohort

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

Mini-Mental State Examination (MMSE)

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

Neuropsychiatric Inventory (NPI)

Functional Activities Questionnaire (FAQ)

Cognitive Function Inventory (CFI)

Zarit Burden Interview (ZBI)

Percentage of Participants with a Change in Living Situation

Time to Transition Across Stages of AD

Desire to Institutionalize Scale (DTI)

Full Information

NCT ID

NCT02951598

First Posted

October 28, 2016

Last Updated

October 3, 2023

Sponsor

Eli Lilly and Company

1. Study Identification

Unique Protocol Identification Number

NCT02951598

Brief Title

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

Acronym

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)

Study Type

Observational

2. Study Status

Record Verification Date

October 2023

Overall Recruitment Status

Active, not recruiting

Study Start Date

October 29, 2016 (Actual)

Primary Completion Date

January 30, 2021 (Actual)

Study Completion Date

April 28, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Eli Lilly and Company

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Alzheimer Disease, Mild Cognitive Impairment

7. Study Design

Enrollment

1400 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

MCI (Amyloid Positive)

Arm Description

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.

Arm Title

Mild AD Dementia (Amyloid Positive)

Arm Description

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.

Arm Title

MCI (Amyloid Negative)

Arm Description

Participants with MCI who tested amyloid negative. These participants were not eligible to participate in the 36 month prospective portion of the study.

Arm Title

Mild Dementia (Amyloid Negative)

Arm Description

Participants with mild dementia who tested amyloid negative. These participants were not eligible to participate in the 36 month prospective portion of the study.

Intervention Type

Drug

Intervention Name(s)

Florbetapir F 18 PET Scan

Other Intervention Name(s)

LY3078786

Intervention Description

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.

Primary Outcome Measure Information:

Title

Mean Economic Cost Associated with Amyloid Positive AD

Time Frame

Baseline through Study Completion (36 Months)

Secondary Outcome Measure Information:

Title

Healthcare Resource Use by AD Cohort

Time Frame

Baseline through Study Completion (36 Months)

Title

Mean Economic Cost by AD Cohort

Time Frame

Baseline through 24 Months

Title

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

Time Frame