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

Active, not recruiting

• Conditions: Mild Cognitive Impairment; Alzheimer Disease
• Interventions: Drug: Florbetapir F 18 PET Scan

• Registration Number: NCT02951598
• Lead Sponsor: Eli Lilly and Company

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-10-28
• Study First Submitted QC: 2016-10-28
• Study Start: 2016-10-29
• Study First Posted: 2016-11-01
• Primary Completion: 2021-01-30
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-23
• Last Update Posted: 2024-10-24
• Study Completion: 2026-04-28

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 1400

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
MCI (Amyloid Negative)	Florbetapir F 18 PET Scan	Participants with MCI who tested amyloid negative. These participants were not eligible to participate in the 36 month prospective portion of the study.
MCI (Amyloid Positive)	Florbetapir F 18 PET Scan	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.
Mild AD Dementia (Amyloid Positive)	Florbetapir F 18 PET Scan	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.
Mild Dementia (Amyloid Negative)	Florbetapir F 18 PET Scan	Participants with mild dementia who tested amyloid negative. These participants were not eligible to participate in the 36 month prospective portion of the study.

Primary Outcome Measures

Name	Time	Method
Mean Economic Cost Associated with Amyloid Positive AD	Baseline through Study Completion (36 Months)

Secondary Outcome Measures

Name	Time	Method
Zarit Burden Interview (ZBI)	Baseline, End of Study (36 Months)
Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-Cog14)	Baseline, End of Study (36 Months)
Time to Transition Across Stages of AD	Baseline through Study Completion (36 Months)
Healthcare Resource Use by AD Cohort	Baseline through Study Completion (36 Months)
Mean Economic Cost by AD Cohort	Baseline through 24 Months
Mini-Mental State Examination (MMSE)	Baseline, End of Study (36 Months)
Neuropsychiatric Inventory (NPI)	Baseline, End of Study (36 Months)
Bath Assessment of Subjective Quality of Life in Dementia (BASQID)	Baseline, End of Study (36 Months)
Functional Activities Questionnaire (FAQ)	Baseline, End of Study (36 Months)
Cognitive Function Inventory (CFI)	Baseline, End of Study (36 Months)
Percentage of Participants with a Change in Living Situation	36 Months
Desire to Institutionalize Scale (DTI)	Baseline through Study Completion (36 Months)

Trial Locations

Locations (76)

California Pharmaceutical Research Institute; 🇺🇸 Anaheim, California, United States

Advanced Research Center; 🇺🇸 Anaheim, California, United States

Sun Valley Research Center; 🇺🇸 Imperial, California, United States

Global Clinical Trials; 🇺🇸 Irvine, California, United States

Irvine Clinical Research Center; 🇺🇸 Irvine, California, United States

Alliance Research Centers; 🇺🇸 Laguna Hills, California, United States

Pacific Clinical Studies, Inc; 🇺🇸 Los Alamitos, California, United States

California Neurological Services, Inc.; 🇺🇸 Panorama City, California, United States

Havana Research Institute; 🇺🇸 Pasadena, California, United States

Clinical Innovations, Inc.; 🇺🇸 Riverside, California, United States

Scroll for more (66 remaining)