Donanemab / Lewy Body Disease / Synucleinopathies · Phase 2 Trial

A Study of Donanemab (LY3002813) in Participants With Early Cognitive Decline (TRAILBLAZER-ALZ 7)

ClinicalTrials.gov · August 6, 2026

Preliminary Why this matters to you Expert discussion

Early or partial results. Treat as a signal, not a conclusion.

AI Summary

This is a Phase 2 registration for a planned randomized trial of donanemab versus placebo in early cognitive decline, estimated to enrol 350 participants with a 52-week primary outcome window. No results are reported in this registry record; the study remains in recruitment.

What was studied

Phase 2, Interventional, Randomized, Parallel, Quadruple masking, Treatment purpose. Cognitive Dysfunction, Lewy Body Disease, Synucleinopathies, Amyloid; age from 55 Years; to 85 Years. Intervention: Donanemab (LY3002813). Compared with: Placebo — Placebo Comparator. n = 350. 71 sites across 4 countries.

Key findings

Safety

Registry record contains no efficacy, safety, or outcome data; study is still recruiting. Primary outcome timepoint is 52 weeks; longer-term safety and durability unknown.

Who this may help

This trial is not yet complete and carries no clinical implications at this stage. Clinicians should await publication of results to assess whether donanemab affects cognitive decline trajectories in early disease.

Plain-language summary

This is a Phase 2 clinical trial registry record with no reported results; it describes a planned study design and enrollment target only.

Study design

As stated by the source record.

MethodsPrimary outcome measure: Change from Baseline on Clinical Dementia Rating - Sum of Boxes (CDR-SB) (assessed at Baseline through Week 52)

DesignPhase 2, Interventional, Randomized, Parallel, Quadruple masking, Treatment purpose

PopulationCognitive Dysfunction, Lewy Body Disease, Synucleinopathies, Amyloid; age from 55 Years; to 85 Years

Sample size350

InterventionDonanemab (LY3002813)

ComparatorPlacebo — Placebo Comparator

Setting71 sites across 4 countries

Reported figures

Quoted from the source exactly as published.

Estimated enrollment350

Primary outcome measureChange from Baseline on Clinical Dementia Rating - Sum of Boxes (CDR-SB), Baseline through Week 52

Study phasePhase 2

Study duration per participantOne and a half years

Clinical bottom line

Caveats

Registry record contains no efficacy, safety, or outcome data; study is still recruiting.
Randomization method, blinding status, and inclusion/exclusion criteria not specified in registry extract.
Primary outcome timepoint is 52 weeks; longer-term safety and durability unknown.
Specific cognitive or functional decline thresholds for eligibility not stated.

Evidence assessment

Graded across the dimensions that decide whether you should act, each from what the source actually supports. There is no single score, and where a dimension was not assessed it says so.

Study design

moderate

Phase 2 interventional RCT with placebo comparator; design adequate but early phase.

Directness

moderate

Primary outcome is CDR-SB, a validated clinical dementia measure; direct to cognitive decline.

Consistency

insufficient

Registry record only; no results reported for comparison with other trials.

Risk of bias

moderate

Placebo-controlled design supports bias mitigation; blinding status not stated in registry.

Sample adequacy

limited

Estimated enrollment 350 participants; Phase 2 size; final sample not yet reported.

What is missing. This record has no key findings. That is a gap in the analysis, not a judgement about the study.

Source abstract

Registry record from ClinicalTrials.gov (NCT07589595). This is a study registration, not published results. Lead sponsor: Eli Lilly and Company. Recruitment status: RECRUITING. Phase: PHASE2. Study type: INTERVENTIONAL. Enrollment: 350 participants (ESTIMATED). Conditions: Cognitive Dysfunction, Lewy Body Disease, Synucleinopathies, Amyloid. Interventions: DRUG: Donanemab; DRUG: Placebo. Primary outcome measures: Change from Baseline on Clinical Dementia Rating - Sum of Boxes (CDR-SB) , Baseline through Week 52. Brief summary: The main purpose of this study is to evaluate whether treatment with donanemab slows the progression of cognitive (how we think, learn, remember, pay attention, and make decisions) and functional (how we are able to perform daily activities) decline. For each participant, the study will last one and a half years.

Follow from this

Taken from the source record, never inferred. Follow any of these and new work involving them reaches your briefing.

Eli Lilly and CompanyDonanemabNCT07589595Lewy Body DiseaseSynucleinopathiesCognitive Dysfunction