A Real-World Comparative Study of Donanemab (LY3002813) Plus Usual Care Versus Usual Care Alone in US Participants With Early Symptomatic Alzheimer's Disease
- Conditions
- Alzheimer Disease
- Registration Number
- NCT06566170
- Lead Sponsor
- Eli Lilly and Company
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not yet recruiting
- Sex
- All
- Target Recruitment
- 3060
Inclusion Criteria:<br><br>Participants<br><br> - are under care for presumed mild cognitive impairment (MCI) or mild dementia stage<br> of AD (Note: neither a biomarker-based diagnosis of AD nor a diagnosis in electronic<br> health records [EHR] is required prior to screening)<br><br> - have a Telephone Interview for Cognitive Status (TICS) score of =21<br><br> - presence of amyloid beta (Aß) pathology supported by biomarker results (e.g., P-tau,<br> amyloid positron emission tomography (PET), and/or cerebrospinal fluid [CSF]).<br> (Note: A historical biomarker may be used for eligibility if performed within 12<br> months of study entry)<br><br> - have a reliable study partner who is in frequent contact with the participant and<br> will be available by telephone at designated times (every 6 months), and<br><br> - have EHR data available for linkage and are willing to allow access to EHR data for<br> the duration of the study.<br><br>Exclusion Criteria:<br><br> - have prior ischemic or hemorrhagic stroke(s) with an inability to independently<br> perform any one or more basic activities of daily living (ADLs) (i.e., walking,<br> transferring, eating, bathing, dressing, or toileting). (Note: mixed dementias with<br> amyloid pathology are permitted)<br><br> - have current or recent serious or unstable illness (other than AD) that, in the<br> investigator's opinion, could interfere with the ability of the participant or study<br> partner to complete the study (e.g., life expectancy of less than 36 months,<br> requirement for long-term (>12 months) institutional-level care, serious psychiatric<br> illness, etc.)<br><br> - are currently enrolled or intend to enroll in a clinical trial of another<br> investigational product, and<br><br> - have contraindications to donanemab, magnetic resonance imaging (MRI), or amyloid<br> PET tracers. (Donanemab group only).
Not provided
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Time to First Increase in Dependence Level Above Baseline (as derived from the Dependence Scale [DS])
- Secondary Outcome Measures
Name Time Method 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 to Institutionalization from Baseline for the Subgroup of Participants not Institutionalized at Baseline;Change from Baseline Over Time (Semi-Annually) in DS Total Score;Change from Baseline Over Time (Assessed Semi-Annually) in Functional Assessment Questionnaire (FAQ) Total Score;Change from Baseline Over Time (Assessed Yearly) in Neuropsychiatric Inventory (NPI-Q) Total Severity Score;Change from Baseline Over Time (Assessed Yearly) in Zarit Burden Inventory-short version (ZBI-12) total score;Change from Baseline Over Time (Assessed Semi-Annually) in Living Situation as Assessed by the Participant Lifestyle Questionnaire (P-LSQ);Change from Baseline Over Time (Assessed Semi-Annually) in Home Healthcare as Assessed by the P-LSQ;Change from Baseline Over Time (Assessed Semi-Annually) in Driving Status as Assessed by the P-LSQ