Alzheimer DiseaseNCT06566170
A Real-World Comparative Study of Donanemab (LY3002813) Plus Usual Care Versus Usual Care Alone in US Participants With Early Symptomatic Alzheimer's Disease
An observational study of Alzheimer Disease, run by Eli Lilly and Company at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Alzheimer Disease
- What is being tested?
- Donanemab
- Type of treatment
- Injection or infusion
- How many people
- 6,250 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Oct 2024to Feb 2033
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or contact
United States1 site, 1 recruiting
- Recruiting
Rehabilitation & Neurological Services
Huntsville, Alabama, 35805-4046
Belinda Savage-Edwards
About this study
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)
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.
- Conditions
- Alzheimer Disease
- Being tested
- Donanemab, Usual Care
- Medical subject headings
- Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DonanemabDrug
Also called LY3002813
Administered IV
Usual CareDrug
Medication (excluding amyloid-targeting agents) or non-pharmacological therapy including watchful waiting.
| Study group | Role | What they receive |
|---|---|---|
| Donanemab Group + Usual Care | Participants will receive open-label (unblinded) donanemab intravenously (IV) and Usual Care Receives: Drug: Donanemab; Drug: Usual Care | |
| Usual Care Group | Participants will receive usual care. Receives: Drug: Usual Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 5 Years
Secondary outcomes (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
Measured: 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.
Measured: Up to 5 Years
Change from Baseline Over Time (Semi-Annually) in DS Total Score
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline, Up to 5 Years
Change from Baseline Over Time (Assessed Semi-Annually) in Home Healthcare as Assessed by the P-LSQ
Measured: Baseline, Up to 5 Years
Change from Baseline Over Time (Assessed Semi-Annually) in Driving Status as Assessed by the P-LSQ
Measured: Baseline, Up to 5 Years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2024
- Study start7 Oct 2024
- Primary completionFeb 2033 (estimated)
- Study completionFeb 2033 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alzheimer DiseaseStudies of the same condition, open and under way.
- More trials run by Eli Lilly and CompanyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 6,250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Eli Lilly and Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- 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), Study director, Eli Lilly and Company
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06566170
- Sponsor's protocol ID
- 18721
- Other IDs
- I5T-MC-AACS
- Status last verified
- Oct 2026
- First submitted
- 20 Aug 2024
- Last updated
- 20 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.