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)

Overview

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.

Interventions

• Drug Donanemab
  Administered IV
• Drug Usual Care
  Medication (excluding amyloid-targeting agents) or non-pharmacological therapy including watchful waiting.

Primary outcome measures

• Time to First Increase in Dependence Level Above Baseline (as derived from the Dependence Scale [DS]) [Time frame: Up to 5 Years]

Secondary outcome measures (9)

• Time to Loss of Independence (Dependence Level ≥3 as derived from the DS) for the Subgroup of Participants with Dependence Level <3 at Baseline [Time frame: Up to 5 Years]
• Time to Institutionalization from Baseline for the Subgroup of Participants not Institutionalized at Baseline [Time frame: Up to 5 Years]
• Change from Baseline Over Time (Semi-Annually) in DS Total Score [Time frame: Baseline, Up to 5 Years]
• Change from Baseline Over Time (Assessed Semi-Annually) in Functional Assessment Questionnaire (FAQ) Total Score [Time frame: Baseline, Up to 5 Years]
• Change from Baseline Over Time (Assessed Yearly) in Neuropsychiatric Inventory (NPI-Q) Total Severity Score [Time frame: Baseline, Up to 5 Years]
• Change from Baseline Over Time (Assessed Yearly) in Zarit Burden Inventory-short version (ZBI-12) total score [Time frame: 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) [Time frame: Baseline, Up to 5 Years]
• Change from Baseline Over Time (Assessed Semi-Annually) in Home Healthcare as Assessed by the P-LSQ [Time frame: Baseline, Up to 5 Years]
• Change from Baseline Over Time (Assessed Semi-Annually) in Driving Status as Assessed by the P-LSQ [Time frame: Baseline, Up to 5 Years]

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).

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model

Cohort

Study locations

United States · 1 center

• Rehabilitation & Neurological Services — Huntsville

Identifiers

NCT: NCT06566170 · 18721 · I5T-MC-AACS

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗