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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02951598
Recruitment Status : Active, not recruiting
First Posted : November 1, 2016
Last Update Posted : December 19, 2020
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company

Study Description
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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.

Condition or disease Intervention/treatment Phase
Alzheimer Disease Mild Cognitive Impairment Drug: Florbetapir F 18 PET Scan Not Applicable

Study Design
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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
Estimated Primary Completion Date : January 22, 2021
Estimated Study Completion Date : April 28, 2023

Resource links provided by the National Library of Medicine


Arms and Interventions
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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.
 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


Outcome Measures
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Primary Outcome Measures :
  1. Mean Economic Cost Associated with Amyloid Positive AD [ Time Frame: Baseline through Study Completion (36 Months) ]

Secondary Outcome Measures :
  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) ]

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   55 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

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


Locations
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Sponsors and Collaborators
Eli Lilly and Company
Investigators
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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
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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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: December 19, 2020
Last Verified: December 15, 2020
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.
Additional relevant MeSH terms:
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Alzheimer Disease
Cognitive Dysfunction
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
 Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders
Cognition Disorders