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

Lilly

Status: Active, not recruiting

Conditions: Alzheimer Disease; Mild Cognitive Impairment

Treatments: Drug: Florbetapir F 18 PET Scan

Study type: Observational

Funder types: Industry

Identifiers

NCT02951598

16466

H8A-US-B004 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 1,400 estimated patients

Sex: All

Ages: 55 to 85 years old

Volunteers: No 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.

Trial design

1,400 participants in 4 patient groups

MCI (Amyloid Positive)

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.

Treatment:

Drug: Florbetapir F 18 PET Scan

Mild AD Dementia (Amyloid Positive)

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.

Treatment:

Drug: Florbetapir F 18 PET Scan

MCI (Amyloid Negative)

Description:

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

Treatment:

Drug: Florbetapir F 18 PET Scan

Mild Dementia (Amyloid Negative)

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.

Treatment:

Drug: Florbetapir F 18 PET Scan