A Study of Health Care Use and Costs in Participants With Early Stage Alzheimer's Disease (AD) (GERAS-US)
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ClinicalTrials.gov Identifier: NCT02951598 |
Recruitment Status :
Active, not recruiting
First Posted : November 1, 2016
Last Update Posted : June 10, 2021
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Condition or disease | Intervention/treatment | Phase |
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Alzheimer Disease Mild Cognitive Impairment | Drug: Florbetapir F 18 PET Scan | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 1400 participants |
Allocation: | Non-Randomized |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Health Services Research |
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) |
Actual Study Start Date : | October 29, 2016 |
Actual Primary Completion Date : | January 30, 2021 |
Estimated Study Completion Date : | April 28, 2023 |

Arm | Intervention/treatment |
---|---|
MCI (Amyloid Positive)
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.
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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.
Other Name: LY3078786 |
Mild AD Dementia (Amyloid Positive)
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.
|
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.
Other Name: LY3078786 |
MCI (Amyloid Negative)
Participants with MCI who tested amyloid negative. These participants were not eligible to participate in the 36 month prospective portion of the study.
|
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.
Other Name: LY3078786 |
Mild Dementia (Amyloid Negative)
Participants with mild dementia who tested amyloid negative. These participants were not eligible to participate in the 36 month prospective portion of the study.
|
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.
Other Name: LY3078786 |
- Mean Economic Cost Associated with Amyloid Positive AD [ Time Frame: Baseline through Study Completion (36 Months) ]
- Healthcare Resource Use by AD Cohort [ Time Frame: Baseline through Study Completion (36 Months) ]
- Mean Economic Cost by AD Cohort [ Time Frame: Baseline through 24 Months ]
- Bath Assessment of Subjective Quality of Life in Dementia (BASQID) [ Time Frame: Baseline, End of Study (36 Months) ]
- Mini-Mental State Examination (MMSE) [ Time Frame: Baseline, End of Study (36 Months) ]
- Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-Cog14) [ Time Frame: Baseline, End of Study (36 Months) ]
- Neuropsychiatric Inventory (NPI) [ Time Frame: Baseline, End of Study (36 Months) ]
- Functional Activities Questionnaire (FAQ) [ Time Frame: Baseline, End of Study (36 Months) ]
- Cognitive Function Inventory (CFI) [ Time Frame: Baseline, End of Study (36 Months) ]
- Zarit Burden Interview (ZBI) [ Time Frame: Baseline, End of Study (36 Months) ]
- Percentage of Participants with a Change in Living Situation [ Time Frame: 36 Months ]
- Time to Transition Across Stages of AD [ Time Frame: Baseline through Study Completion (36 Months) ]
- Desire to Institutionalize Scale (DTI) [ Time Frame: Baseline through Study Completion (36 Months) ]

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 55 Years to 85 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02951598

Study Director: | 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) | Eli Lilly and Company |
Responsible Party: | Eli Lilly and Company |
ClinicalTrials.gov Identifier: | NCT02951598 |
Other Study ID Numbers: |
16466 H8A-US-B004 ( Other Identifier: Eli Lilly and Company ) |
First Posted: | November 1, 2016 Key Record Dates |
Last Update Posted: | June 10, 2021 |
Last Verified: | June 2021 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Yes |
Plan Description: | Lilly provides access to the individual patient data from studies on approved medicines and indications as defined by the sponsor specific information on ClinicalStudyDataRequest.com. This access is provided in a timely fashion after the primary publication is accepted. Researchers need to have an approved research proposal submitted through ClinicalStudyDataRequest.com. Access to the data will be provided in a secure data sharing environment after signing a data sharing agreement. |
Alzheimer Disease Cognitive Dysfunction Dementia Brain Diseases Central Nervous System Diseases Nervous System Diseases |
Tauopathies Neurodegenerative Diseases Neurocognitive Disorders Mental Disorders Cognition Disorders |