Clinical trial NCT06566170: A Real-World Comparative Study of Donanemab (LY3002813) Plus Usual Care Versus Usual Care Alone in US Participants With Early Symptomatic Alzheimer's Disease
Official title: Long-Term Real-World Comparative Effectiveness of Donanemab Plus Usual Care Versus Usual Care Alone in US Patients With Early Symptomatic Alzheimer's Disease (TRAILBLAZER-REAL US)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Alzheimer Disease
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2024-08-22
Enrollment: 3060
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population will consist of a donanemab plus usual care group and a usual care alone group. Participants will be enrolled 1:2 into donanemab plus usual care and usual care alone groups to allow enough participants in the usual care group to be matched with participants in the donanemab group to enable robust comparative effectiveness analyses.

Brief 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.


Eligibility criteria: Inclusion Criteria:

Participants

* are under care for presumed mild cognitive impairment (MCI) or mild dementia stage of AD (Note: neither a biomarker-based diagnosis of AD nor a diagnosis in electronic health records \[EHR\] is required prior to screening)
* have a Telephone Interview for Cognitive Status (TICS) score of ≥21
* presence of amyloid beta (Aβ) pathology supported by biomarker results (e.g., P-tau, amyloid positron emission tomography (PET), and/or cerebrospinal fluid \[CSF\]). (Note: A historical biomarker may be used for eligibility if performed within 12 months of study entry)
* have a reliable study partner who is in frequent contact with the participant and will be available by telephone at designated times (every 6 months), and
* have EHR data available for linkage and are willing to allow access to EHR data for the duration of the study.

Exclusion Criteria:

* have prior ischemic or hemorrhagic stroke(s) with an inability to independently perform any one or more basic activities of daily living (ADLs) (i.e., walking, transferring, eating, bathing, dressing, or toileting). (Note: mixed dementias with amyloid pathology are permitted)
* have current or recent serious or unstable illness (other than AD) that, in the investigator's opinion, could interfere with the ability of the participant or study partner to complete the study (e.g., life expectancy of less than 36 months, requirement for long-term (\>12 months) institutional-level care, serious psychiatric illness, etc.)
* are currently enrolled or intend to enroll in a clinical trial of another investigational product, and
* have contraindications to donanemab, magnetic resonance imaging (MRI), or amyloid PET tracers. (Donanemab group only).

Primary outcomes:
measure: Time to First Increase in Dependence Level Above Baseline (as derived from the Dependence Scale [DS])
timeFrame: Up to 5 Years
Secondary outcomes:
measure: Time to Loss of Independence (Dependence Level ≥3 as derived from the DS) for the Subgroup of Participants with Dependence Level <3 at Baseline
timeFrame: Up to 5 Years
measure: Time to Institutionalization from Baseline for the Subgroup of Participants not Institutionalized at Baseline
timeFrame: Up to 5 Years
measure: Change from Baseline Over Time (Semi-Annually) in DS Total Score
timeFrame: Baseline, Up to 5 Years
measure: Change from Baseline Over Time (Assessed Semi-Annually) in Functional Assessment Questionnaire (FAQ) Total Score
timeFrame: Baseline, Up to 5 Years
measure: Change from Baseline Over Time (Assessed Yearly) in Neuropsychiatric Inventory (NPI-Q) Total Severity Score
timeFrame: Baseline, Up to 5 Years
measure: Change from Baseline Over Time (Assessed Yearly) in Zarit Burden Inventory-short version (ZBI-12) total score
timeFrame: Baseline, Up to 5 Years
measure: Change from Baseline Over Time (Assessed Semi-Annually) in Living Situation as Assessed by the Participant Lifestyle Questionnaire (P-LSQ)
timeFrame: Baseline, Up to 5 Years
measure: Change from Baseline Over Time (Assessed Semi-Annually) in Home Healthcare as Assessed by the P-LSQ
timeFrame: Baseline, Up to 5 Years
measure: Change from Baseline Over Time (Assessed Semi-Annually) in Driving Status as Assessed by the P-LSQ
timeFrame: Baseline, Up to 5 Years
Other outcomes:
Locations:
city: Huntsville
country: United States
facility: Rehabilitation & Neurological Services
state: Alabama
Study officials:
affiliation: Eli Lilly and Company
name: 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)
role: STUDY_DIRECTOR
References: