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NCT Number: 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

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.

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Key information

Conditions

Alzheimer Disease Brain Diseases Central Nervous System Diseases Dementia Mental Disorders Nervous System Diseases Neurocognitive Disorders Neurodegenerative Diseases Tauopathies

Age range

60 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Rehabilitation & Neurological Services

Huntsville, Alabama, 35805-4046, United States

Location status: Recruiting

Location contact

Belinda Savage-Edwards

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Donanemab

Drug

Administered IV

Other names: LY3002813

Usual Care

Drug

Medication (excluding amyloid-targeting agents) or non-pharmacological therapy including watchful waiting.

Primary outcomes

  1. Time to First Increase in Dependence Level Above Baseline (as derived from the Dependence Scale [DS])

    Time frame: Up to 5 Years

    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.

Secondary outcomes

  1. 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

  2. Time to Institutionalization from Baseline for the Subgroup of Participants not Institutionalized at Baseline

    Time frame: Up to 5 Years

    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.

  3. Change from Baseline Over Time (Semi-Annually) in DS Total Score

    Time frame: Baseline, Up to 5 Years

  4. Change from Baseline Over Time (Assessed Semi-Annually) in Functional Assessment Questionnaire (FAQ) Total Score

    Time frame: Baseline, Up to 5 Years

    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.

  5. Change from Baseline Over Time (Assessed Yearly) in Neuropsychiatric Inventory (NPI-Q) Total Severity Score

    Time frame: Baseline, Up to 5 Years

    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.

  6. Change from Baseline Over Time (Assessed Yearly) in Zarit Burden Inventory-short version (ZBI-12) total score

    Time frame: Baseline, Up to 5 Years

    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.

  7. 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

    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.

  8. Change from Baseline Over Time (Assessed Semi-Annually) in Home Healthcare as Assessed by the P-LSQ

    Time frame: Baseline, Up to 5 Years

  9. Change from Baseline Over Time (Assessed Semi-Annually) in Driving Status as Assessed by the P-LSQ

    Time frame: Baseline, Up to 5 Years

Study contacts

Contact information is provided by the study sponsor or research team.

There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or

CONTACT

[email protected]

1-317-615-4559

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Registry information

Official study 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)

Important dates

Study start
2024
Primary completion
2033
Study completion
2033
First posted
Aug 22, 2024
Registry last updated
Oct 9, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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