A Real-World Comparative Study of Donanemab (LY3002813) Plus Usual Care Versus Usual Care Alone in US Participants With Early Symptomatic Alzheimer's Disease
NCT Number: NCT06566170
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Alzheimer Disease
Interventions: DRUG: Donanemab|DRUG: Usual Care
Sponsor: Eli Lilly and Company
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 3060
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-10
Completion Date: 2031-05

Summary:
The main purpose of this study is to evaluate the long-term effectiveness of donanemab plus usual care versus usual care alone in participants with early symptomatic AD. The study will employ a prospective, observational cohort design with participant management resembling real-world practice to the greatest extent possible via prospective assessments and linkage to historical and prospective electronic health records. The study will last about 273 weeks and may include up to 28 visits.

Primary Outcome Measures: Time to First Increase in Dependence Level Above Baseline (as derived from the Dependence Scale [DS]), The DS is a caregiver-reported outcome assessing the need for daily in-home or institutional assistance by participants with AD. The DS is completed as a structured interview with a knowledgeable caregiver or study partner. The scale is composed of 13 items evaluating progressive needs for assistance. The total score ranges from 0 to 15, with higher scores indicating a greater degree of dependence on external support., Up to 5 Years
Secondary Outcome Measures: Time to Loss of Independence (Dependence Level ≥3 as derived from the DS) for the Subgroup of Participants with Dependence Level <3 at Baseline, Up to 5 Years|Time to Institutionalization from Baseline for the Subgroup of Participants not Institutionalized at Baseline, Participants who endorse, "Assisted living facility" or "Skilled nursing facility, nursing home, hospice" as their primary residence on the participant lifestyle status Questionnaire (P-LSQ) will be considered institutionalized., Up to 5 Years|Change from Baseline Over Time (Semi-Annually) in DS Total Score, Baseline, Up to 5 Years|Change from Baseline Over Time (Assessed Semi-Annually) in Functional Assessment Questionnaire (FAQ) Total Score, The FAQ is a brief, 10-item caregiver-reported outcome measure assessing performance on functional activities impacted early during AD. The maximum total score is 30, with higher scores indicating greater impairment., Baseline, Up to 5 Years|Change from Baseline Over Time (Assessed Yearly) in Neuropsychiatric Inventory (NPI-Q) Total Severity Score, The NPI-Q is a brief, caregiver-reported assessment of neuropsychiatric symptoms associated with dementia. The NPI-Q yields total scores for Severity and Distress, reflecting the sum of ratings across all domains, with higher scores indicating a greater degree of symptom severity and caregiver distress, respectively., Baseline, Up to 5 Years|Change from Baseline Over Time (Assessed Yearly) in Zarit Burden Inventory-short version (ZBI-12) total score, ZBI is a caregiver-reported instrument used widely to evaluate caregiver burden associated with AD and other diseases such as multiple sclerosis, congestive heart failure, and cancer. Items on the ZBI-12 assess caregiver stress, time available for self, and the impact of caring on the caregiver's social life. Responses are provided on a 5-point Likert scale (never=0, nearly always=4). The ZBI-12 total score has a range of 0 to 48, with higher scores indicating greater caregiver burden., Baseline, Up to 5 Years|Change from Baseline Over Time (Assessed Semi-Annually) in Living Situation as Assessed by the Participant Lifestyle Questionnaire (P-LSQ), The P-LSQ is a brief, sponsor-created questionnaire used to collect supplementary data regarding participants' living environment, home healthcare needs, and driving status that is not captured elsewhere., Baseline, Up to 5 Years|Change from Baseline Over Time (Assessed Semi-Annually) in Home Healthcare as Assessed by the P-LSQ, Baseline, Up to 5 Years|Change from Baseline Over Time (Assessed Semi-Annually) in Driving Status as Assessed by the P-LSQ, Baseline, Up to 5 Years