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NCT06566170 · ClinicalTrials.gov registry record
A Real-World Comparative Study of Donanemab (LY3002813) Plus Usual Care Versus Usual Care Alone in US Participants With Early Symptomatic Alzheimer's Disease
A clinical trial of Alzheimer Disease, sponsored by Eli Lilly and Company.
- Recruiting
- Registry status
- 6,250
- Enrollment target
- 1
- Study location
NCT06566170: Recruiting study of Alzheimer Disease, sponsored by Eli Lilly and Company.
NCT06566170 is a study of Alzheimer Disease that is actively recruiting participants, run by Eli Lilly and Company. The registered enrollment target is 6,250 participants, above the 2,730-participant average among 306 other Alzheimer Disease trials with a reported enrollment target (129% higher). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06566170, a study of Alzheimer Disease, is actively recruiting participants, sponsored by Eli Lilly and Company.
- RECRUITING
- Registry status
- 6,250 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
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.
Conditions Studied
Interventions
- DRUG Usual Care
- DRUG Donanemab
Study Locations (1)
Alabama
- Rehabilitation & Neurological Services - Huntsville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 6,250 participants |
| Start Date | 2024-10-07 |
| Est. Completion | 2033-02 |
What NCT06566170 shows while recruiting
NCT06566170 is an observational study that tracks outcomes without assigning an intervention. Its 6,250 participants enrollment target places it among the larger protocols in the corpus, above the 2,730-participant average among 306 other Alzheimer Disease trials with a reported enrollment target (129% higher).
The record links to 1 condition, with Alzheimer Disease appearing as the primary indexed condition, and to 2 interventions - of which Usual Care is the first listed.
NCT06566170 reports a single indexed study location in Alabama.
Frequently Asked Questions
What is clinical trial NCT06566170 about?
NCT06566170 is a clinical study titled "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...
What is the current status of trial NCT06566170?
This trial is currently recruiting. The enrollment target is 6,250 participants. The study started on 2024-10-07. Estimated completion is 2033-02.
What conditions does trial NCT06566170 study?
This clinical trial studies the following conditions: Alzheimer Disease.
What interventions are being tested in trial NCT06566170?
The interventions under investigation include: Usual Care (DRUG), Donanemab (DRUG).
Who is sponsoring clinical trial NCT06566170?
This trial is sponsored by Eli Lilly and Company, which has 1,341 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06566170 being conducted?
This trial has 1 study location across Alabama. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Alzheimer Disease
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT06566170's enrollment target sits among peer trials
6,250 14th of 306 higher than 293 of 306 other Alzheimer Disease trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Alzheimer Disease trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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