Trial · NCT07589595
A Study of Donanemab (LY3002813) in Participants With Early Cognitive Decline (TRAILBLAZER-ALZ 7)
NCT07589595, Phase 2, Recruiting, Eli Lilly and Company
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Study of Donanemab (LY3002813) in Participants With Early Cognitive Decline (TRAILBLAZER-ALZ 7). Trials, record NCT07589595. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07589595
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study of Donanemab (LY3002813) in Participants With Early Cognitive Decline (TRAILBLAZER-ALZ 7)
- NCT number
- NCT07589595
- Status
- Recruiting
- Phases
- Phase 2
- Enrollment
- 350 participants, estimated
- Lead sponsor
- Eli Lilly and Company
- Conditions
- Cognitive Dysfunction, Lewy Body Disease, Synucleinopathies, Amyloid
- Interventions
- Donanemab, Placebo
- First posted
- 2026-05-15
- Last updated
- 2026-11-04
Source ClinicalTrials.gov
Registered outcomes10
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change from Baseline on Clinical Dementia Rating - Sum of Boxes (CDR-SB) | Baseline through Week 52 | |
| Secondary | Change from Baseline for Integrated Alzheimer's Disease Rating Scale (iADRS) | Baseline through Week 52 | |
| Secondary | Change from Baseline for Alzheimer's Disease Assessment Scale - Cognitive Subscale, 13 items (ADAS-Cog13) | Baseline through Week 52 | |
| Secondary | Change from Baseline for Alzheimer's Disease Cooperative Study - Instrumental Activities of Daily Living Inventory (ADCS-iADL) | Baseline through Week 52 | |
| Secondary | Time to Clinical Progression of Dementia as Measured by Clinical Dementia Rating - Global Score (CDR-GS) | Baseline through Week 52 | |
| Secondary | Change from Baseline in Brain Amyloid Plaque Levels | Baseline through Week 52 | |
| Secondary | Trough Concentration at Steady State | Baseline through Week 52 | |
| Secondary | Maximum Concentration at Steady State | Baseline through Week 52 | |
| Secondary | Antidrug Antibodies (ADA) Against Donanemab | Baseline through Week 52 | |
| Secondary | Frequency of Neutralizing Antibodies to Donanemab Treatment-Emergent ADA-Positive Participants | Baseline through Week 52 |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT07589595
GET https://conductscience.org/api/trials/v1/NCT07589595/registered