Trial · NCT04437511
A Study of Donanemab (LY3002813) in Participants With Early Alzheimer's Disease (TRAILBLAZER-ALZ 2)
NCT04437511, Phase 3, Active not recruiting, Eli Lilly and Company; results first posted 2024-05-20
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study of Donanemab (LY3002813) in Participants With Early Alzheimer's Disease (TRAILBLAZER-ALZ 2). Trials, record NCT04437511. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04437511
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study of Donanemab (LY3002813) in Participants With Early Alzheimer's Disease (TRAILBLAZER-ALZ 2)
- NCT number
- NCT04437511
- Status
- Active not recruiting
- Phases
- Phase 3
- Enrollment
- 1,736 participants, actual
- Lead sponsor
- Eli Lilly and Company
- Conditions
- Alzheimer Disease
- Interventions
- Donanemab, Placebo
- First posted
- 2020-06-18
- Last updated
- 2026-08-26
- Other registries' IDs
- eudract:2020-000077-25
- Results first posted
- 2024-05-20
Source ClinicalTrials.gov
Registered outcomes15
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Baseline on the Integrated Alzheimer's Disease Rating Scale (iADRS) (Overall Population) | Baseline, Week 76 | Integrated Alzheimer's Disease Rating Scale is used to assess whether donanemab slows down the clinical decline associated with AD compared with placebo. iADRS is an integrated assessment of cognition and daily function comprised of items from the ADAS-Cog13 and the Alzheimer's disease cooperative study-instrumental activities of daily living scale (ADCS-iADL). The scale ranges from 0 to 144, where lower scores indicate worse performance and higher score indicates better performance. Least Squares (LS) Mean value was adjusted for basis expansion terms (two terms), basis expansion term-by-treatment interaction, and covariates for age at baseline, pooled investigator, baseline tau level, and baseline acetylcholinesterase inhibitor (AchI)/Memantine use. |
| Primary | Change From Baseline on the Integrated Alzheimer's Disease Rating Scale (iADRS) (Intermediate (Low-medium) Tau Population) | Baseline, Week 76 | Integrated Alzheimer's Disease Rating Scale is used to assess whether donanemab slows down the clinical decline associated with AD compared with placebo. iADRS is an integrated assessment of cognition and daily function comprised of items from the Alzheimer's disease assessment scale-cognitive subscale (ADAS-Cog13) and the Alzheimer's disease cooperative study-instrumental activities of daily living scale (ADCS-iADL). The scale ranges from 0 to 144, where lower scores indicate worse performance and higher score indicates better performance. LS Mean value was adjusted for basis expansion terms (two terms), basis expansion term-by-treatment interaction, and covariates for age at baseline, pooled investigator, and baseline AchI/Memantine use. |
| Secondary | Change From Baseline on the Mini Mental State Examination (MMSE) Score (Overall Population) | Baseline, Week 76 | MMSE is an instrument used to assess cognitive function (orientation, memory, attention, ability to name objects, follow verbal/written commands, write a sentence, and copy figures). Total score ranges from 0 to 30; lower score indicates greater disease severity. LS Mean value was adjusted for basis expansion terms (two terms), basis expansion term-by-treatment interaction, and covariates for age at baseline, pooled investigator, baseline tau level, and baseline AchI/Memantine use. |
| Secondary | Change From Baseline on the Mini Mental State Examination (MMSE) Score (Intermediate (Low-medium) Tau Population) | Baseline, Week 76 | MMSE is an instrument used to assess cognitive function (orientation, memory, attention, ability to name objects, follow verbal/written commands, write a sentence, and copy figures). Total score ranges from 0 to 30; lower score indicates greater disease severity. LS Mean value was adjusted for basis expansion terms (two terms), basis expansion term-by-treatment interaction, and covariates for age at baseline, pooled investigator, and baseline AchI/Memantine use. |
| Secondary | Change From Baseline on the Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-Cog13) (Overall Population) | Baseline, Week 76 | The ADAS-Cog13 is a rater administered instrument that was designed to assess the severity of the dysfunction in the cognitive and noncognitive behaviors characteristic of persons with AD. The cognitive subscale of the ADAS-Cog13 consists of 13 items assessing areas of cognitive function most typically impaired in AD: orientation, verbal memory, language, praxis, delayed free recall, digit cancellation. The ADAS-Cog13 scale ranges from 0 to 85. Higher scores indicate greater disease severity. LS Mean value was adjusted for basis expansion terms (two terms), basis expansion term-by-treatment interaction, and covariates for age at baseline, pooled investigator, baseline tau level, and baseline AchI/Memantine use. |
| Secondary | Change From Baseline on the Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-Cog13) (Intermediate (Low-medium) Tau Population) | Baseline, Week 76 | The ADAS is a rater administered instrument that was designed to assess the severity of the dysfunction in the cognitive and noncognitive behaviors characteristic of persons with AD. The cognitive subscale of the ADAS-cog consists of 13 items assessing areas of cognitive function most typically impaired in AD: orientation, verbal memory, language, praxis, delayed free recall, digit cancellation. The ADAS-Cog13 scale ranges from 0 to 85. Higher scores indicate greater disease severity. LS Mean value was adjusted for basis expansion terms (two terms), basis expansion term-by-treatment interaction, and covariates for age at baseline, pooled investigator, and baseline AchI/Memantine use. |
| Secondary | Change From Baseline on the Clinical Dementia Rating Scale-Sum of Boxes (CDR-SB) (Overall Population) | Baseline, Week 76 | CDR-SB is a semi-structured interview of participants and their caregivers. Participant's cognitive status is rated across 6 domains of functioning, including memory, orientation, judgment/problem solving, community affairs, home/hobbies, and personal care. Severity score assigned for each of 6 domains; Total score (SB) ranges from 0 to 18. Higher scores indicate greater disease severity. LS Mean value was adjusted for treatment, visit, treatment-by-visit interaction, and covariates for baseline score, baseline score-by-visit interaction, age at baseline, baseline tau category, pooled investigator, and baseline AchI/Memantine use. |
| Secondary | Change From Baseline on the Clinical Dementia Rating Scale-Sum of Boxes (CDR-SB) (Intermediate (Low-medium) Tau Population) | Baseline, Week 76 | CDR-SB is a semi-structured interview of participants and their caregivers. Participant's cognitive status is rated across 6 domains of functioning, including memory, orientation, judgment/problem solving, community affairs, home/hobbies, and personal care. Severity score assigned for each of 6 domains; Total score (SB) ranges from 0 to 18. Higher scores indicate greater disease severity. LS Mean value was adjusted for treatment, visit, treatment-by-visit interaction, and covariates for baseline score, baseline score-by-visit interaction, age at baseline, pooled investigator, and baseline AchI/Memantine use. |
| Secondary | Change From Baseline on the Alzheimer's Disease Cooperative Study - Instrumental Activities of Daily Living (ADCS-iADL) Score (Overall Population) | Baseline, Week 76 | The ADCS-ADL is a 23-item inventory developed as a rater-administered questionnaire answered by the participant's caregiver. The ADCS-ADL measures both basic and instrumental activities (instrumental activity items 6a, 7-23) of daily living by participants. The range for the ADCS-iADL is 0-59 with higher scores reflecting better performance. LS Mean value was adjusted for basis expansion terms (two terms), basis expansion term-by-treatment interaction, and covariates for age at baseline, pooled investigator, baseline tau level, and baseline AchI/Memantine use. |
| Secondary | Change From Baseline on the Alzheimer's Disease Cooperative Study - Instrumental Activities of Daily Living (ADCS-iADL) Score (Intermediate (Low-medium) Tau Population) | Baseline, Week 76 | The ADCS-ADL is a 23-item inventory developed as a rater-administered questionnaire answered by the participant's caregiver. The ADCS-ADL measures both basic and instrumental activities (instrumental activity items 6a, 7-23) of daily living by participants. The range for the ADCS-iADL is 0-59 with higher scores reflecting better performance. LS Mean value was adjusted for basis expansion terms (two terms), basis expansion term-by-treatment interaction, and covariates for age at baseline, pooled investigator, and baseline AchI/Memantine use. |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 registered outcomesOutcomes15
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change From Baseline on the Integrated Alzheimer's Disease Rating Scale (iADRS) (Overall Population) | Baseline, Week 76 | All randomized participants with a baseline and at least one postbaseline iADRS data point. | score on a scale | LEAST_SQUARES_MEAN |
| PRIMARY | Change From Baseline on the Integrated Alzheimer's Disease Rating Scale (iADRS) (Intermediate (Low-medium) Tau Population) | Baseline, Week 76 | All randomized participants with baseline Intermediate Tau level and with baseline and at least one postbaseline iADRS data point. | score on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline on the Mini Mental State Examination (MMSE) Score (Overall Population) | Baseline, Week 76 | All randomized participants with a baseline and at least one postbaseline MMSE data point. | score on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline on the Mini Mental State Examination (MMSE) Score (Intermediate (Low-medium) Tau Population) | Baseline, Week 76 | All randomized participants with baseline Intermediate Tau level and with baseline and at least one postbaseline MMSE data point. | score on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline on the Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-Cog13) (Overall Population) | Baseline, Week 76 | All randomized participants with a baseline and at least one postbaseline ADAS-Cog13 data point. | score on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline on the Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-Cog13) (Intermediate (Low-medium) Tau Population) | Baseline, Week 76 | All randomized participants with baseline Intermediate Tau level and with baseline and at least one postbaseline ADAS-Cog13 data point. | score on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline on the Clinical Dementia Rating Scale-Sum of Boxes (CDR-SB) (Overall Population) | Baseline, Week 76 | All randomized participants with a baseline and at least one postbaseline CDR-SB data point. | score on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline on the Clinical Dementia Rating Scale-Sum of Boxes (CDR-SB) (Intermediate (Low-medium) Tau Population) | Baseline, Week 76 | All randomized participants with baseline Intermediate Tau level and with baseline and at least one postbaseline CDR-SB data point. | score on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline on the Alzheimer's Disease Cooperative Study - Instrumental Activities of Daily Living (ADCS-iADL) Score (Overall Population) | Baseline, Week 76 | All randomized participants with a baseline and at least one postbaseline ADCS-iADL data point. | score on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline on the Alzheimer's Disease Cooperative Study - Instrumental Activities of Daily Living (ADCS-iADL) Score (Intermediate (Low-medium) Tau Population) | Baseline, Week 76 | All randomized participants with a baseline Intermediate Tau level and with baseline and at least one postbaseline ADCS-iADL data point. | score on a scale | LEAST_SQUARES_MEAN |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 outcomesResults by group33
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change From Baseline on the Integrated Alzheimer's Disease Rating Scale (iADRS) (Overall Population) | Donanemab | -10.19 | Standard Error 0.53 | score on a scale | |
| Change From Baseline on the Integrated Alzheimer's Disease Rating Scale (iADRS) (Overall Population) | Placebo | -13.11 | Standard Error 0.50 | score on a scale | |
| Change From Baseline on the Integrated Alzheimer's Disease Rating Scale (iADRS) (Intermediate (Low-medium) Tau Population) | Donanemab | -6.02 | Standard Error 0.50 | score on a scale | |
| Change From Baseline on the Integrated Alzheimer's Disease Rating Scale (iADRS) (Intermediate (Low-medium) Tau Population) | Placebo | -9.27 | Standard Error 0.49 | score on a scale | |
| Change From Baseline on the Mini Mental State Examination (MMSE) Score (Overall Population) | Donanemab | -2.47 | Standard Error 0.14 | score on a scale | |
| Change From Baseline on the Mini Mental State Examination (MMSE) Score (Overall Population) | Placebo | -2.94 | Standard Error 0.13 | score on a scale | |
| Change From Baseline on the Mini Mental State Examination (MMSE) Score (Intermediate (Low-medium) Tau Population) | Donanemab | -1.61 | Standard Error 0.14 | score on a scale | |
| Change From Baseline on the Mini Mental State Examination (MMSE) Score (Intermediate (Low-medium) Tau Population) | Placebo | -2.09 | Standard Error 0.14 | score on a scale | |
| Change From Baseline on the Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-Cog13) (Overall Population) | Donanemab | 5.46 | Standard Error 0.28 | score on a scale | |
| Change From Baseline on the Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-Cog13) (Overall Population) | Placebo | 6.79 | Standard Error 0.27 | score on a scale |
1 to 10 of 33Source ClinicalTrials.gov
See all 33 results by groupParticipant flow8
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Donanemab | 860 | |
| Overall Study | STARTED | Placebo | 876 | |
| Overall Study | Received at Least One Dose of Drug (Safety Population) | Donanemab | 853 | |
| Overall Study | Received at Least One Dose of Drug (Safety Population) | Placebo | 874 | |
| Overall Study | COMPLETED | Donanemab | 622 | |
| Overall Study | COMPLETED | Placebo | 698 | |
| Overall Study | NOT COMPLETED | Donanemab | 238 | |
| Overall Study | NOT COMPLETED | Placebo | 178 |
Source ClinicalTrials.gov
Adverse events432
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Diarrhoea | Gastrointestinal disorders | Donanemab | 43 | 853 | 51 |
| other | Diarrhoea | Gastrointestinal disorders | Placebo | 50 | 874 | 56 |
| other | Fatigue | General disorders | Donanemab | 42 | 853 | 43 |
| other | Fatigue | General disorders | Placebo | 45 | 874 | 68 |
| other | Covid-19 | Infections and infestations | Donanemab | 130 | 853 | 135 |
| other | Covid-19 | Infections and infestations | Placebo | 150 | 874 | 157 |
| other | Urinary tract infection | Infections and infestations | Donanemab | 42 | 853 | 52 |
| other | Urinary tract infection | Infections and infestations | Placebo | 56 | 874 | 65 |
| other | Fall | Injury, poisoning and procedural complications | Donanemab | 111 | 853 | 149 |
| other | Fall | Injury, poisoning and procedural complications | Placebo | 109 | 874 | 141 |
1 to 10 of 432Source ClinicalTrials.gov
See all 432 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Donanemab | 16 | 853 |
| Total, all-cause mortality | Placebo | 10 | 874 |
| Total, other adverse events | Donanemab | 567 | 853 |
| Total, other adverse events | Placebo | 425 | 874 |
| Total, serious adverse events | Donanemab | 148 | 853 |
| Total, serious adverse events | Placebo | 138 | 874 |
Source ClinicalTrials.gov
Papers15
The papers the trial lists on ClinicalTrials.gov.
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 comparisons3
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Donanemab vs Placebo: Number or Participants With Anti-Donanemab Antibodies | Trial comparisons |
| Donanemab vs Placebo: deaths from any cause | Trial comparisons |
| Donanemab vs Placebo: serious adverse events | Trial comparisons |
Tests2
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|---|---|
| Cancellation Test | Secondary outcome | ConductCognition |
| Delayed Recall Module | Secondary outcome | ConductCognition |
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/NCT04437511
GET https://conductscience.org/api/trials/v1/NCT04437511/results?page=2