Trial · NCT02477800
221AD301 Phase 3 Study of Aducanumab (BIIB037) in Early Alzheimer's Disease
NCT02477800, Phase 3, Terminated, Biogen; results first posted 2021-09-02
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. 221AD301 Phase 3 Study of Aducanumab (BIIB037) in Early Alzheimer's Disease. Trials, record NCT02477800. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02477800
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- 221AD301 Phase 3 Study of Aducanumab (BIIB037) in Early Alzheimer's Disease
- NCT number
- NCT02477800
- Status
- Terminated
- Phases
- Phase 3
- Enrollment
- 1,653 participants, actual
- Lead sponsor
- Biogen
- Conditions
- Alzheimer's Disease
- Interventions
- Aducanumab (BIIB037), Aducanumab (BIIB037), Placebo
- First posted
- 2015-06-23
- Last updated
- 2021-09-02
- Other registries' IDs
- eudract:2015-000966-72
- Results first posted
- 2021-09-02
- Limitations and caveats
The study was halted prematurely based on a prespecified futility analysis and not based on safety concerns. Participants discontinued due to study termination are included in Reason not Specified category in participant flow tables above.
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Baseline in Clinical Dementia Rating Sum of Boxes (CDR-SB) Score at Week 78 | Baseline, Week 78 | CDR-SB integrates assessments from 3 domains of cognition (memory, orientation, judgment/problem-solving) and 3 domains of function (community affairs, home/hobbies, personal care). Following caregiver interview and systematic patient examination, the rater assigns a score describing the participant's current performance level in each of these domains of life functioning. Prespecified severity anchors range from none = 0, questionable = 0.5, mild = 1, moderate = 2 to severe = 3 (the personal care domain omits the 0.5 score). "Sum of boxes" scoring methodology sums the score for each of the 6 domains and provides a value ranging from 0 to 18 that can change in increments of 0.5 or greater. Higher scores indicate greater disease severity. Mixed model for repeated measures (MMRM) analysis was used to analyze change from baseline in CDR-SB. A positive change from baseline indicates clinical decline. |
| Secondary | Change From Baseline in Mini-Mental State Examination (MMSE) Score at Week 78 | Baseline, Week 78 | The MMSE is a widely used performance-based test of global cognitive status. It consists of 11 tasks that assess orientation, word recall, attention and calculation, language abilities, and visuospatial functions. The scores from the 11 tests are combined to obtain the total score, which ranges from 0 to 30, with lower scores over time indicating increasing cognitive impairment. MMRM analysis was used to analyze change from baseline in MMSE. A negative change from baseline indicates clinical decline. |
| Secondary | Change From Baseline in Alzheimer's Disease Assessment Scale-Cognitive Subscale (13 Items) (ADAS-Cog 13) Score at Week 78 | Baseline, Week 78 | ADAS-Cog13 comprises both cognitive tasks and clinical ratings of cognitive performance. The scale items capture word recall, ability to follow commands, the ability to correctly copy or draw an image, naming, the ability to interact with everyday objects, orientation, word recognition, memory, comprehension of spoken language, word-finding, and language ability, with a measure for delayed word recall and concentration/distractibility. The total score ranges from 0 to 85. An increase in score over time indicates increasing cognitive impairment. MMRM analysis was used to analyze change from baseline in ADAS-Cog 13. A positive change from baseline indicates clinical decline. |
| Secondary | Change From Baseline in Alzheimer's Disease Cooperative Study-Activities of Daily Living Inventory (Mild Cognitive Impairment Version) (ADCS-ADL-MCI) Score at Week 78 | Baseline, Week 78 | The ADCS-ADL-MCI consists of 17 instrumental items (e.g., shopping, preparing meals, using household appliances) and 1 basic item (getting dressed). Ratings reflect caregiver observations about the patient's actual functioning over the previous month and provide an assessment of change in the functional state of the participant over time. The total score ranges from 0 to 53, with lower values over time reflecting functional deterioration. MMRM analysis was used to analyze change from baseline in ADAS-ADL-MCI. A negative change from baseline indicates clinical decline. |
Source ClinicalTrials.gov
Outcomes4
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change From Baseline in Clinical Dementia Rating Sum of Boxes (CDR-SB) Score at Week 78 | Baseline, Week 78 | ITT was defined as all randomized participants who had received at least one dose of study treatment (Aducanumab or Placebo). 'Number of Participants Analyzed' signifies number of participants analyzed in this outcome measure. | score on a scale | MEAN |
| SECONDARY | Change From Baseline in Mini-Mental State Examination (MMSE) Score at Week 78 | Baseline, Week 78 | ITT was defined as all randomized participants who had received at least one dose of study treatment (Aducanumab or Placebo). 'Number of Participants Analyzed' signifies number of participants analyzed in this outcome measure. | score on a scale | MEAN |
| SECONDARY | Change From Baseline in Alzheimer's Disease Assessment Scale-Cognitive Subscale (13 Items) (ADAS-Cog 13) Score at Week 78 | Baseline, Week 78 | ITT was defined as all randomized participants who had received at least one dose of study treatment (Aducanumab or Placebo). 'Number of Participants Analyzed' signifies number of participants analyzed in this outcome measure. | score on a scale | MEAN |
| SECONDARY | Change From Baseline in Alzheimer's Disease Cooperative Study-Activities of Daily Living Inventory (Mild Cognitive Impairment Version) (ADCS-ADL-MCI) Score at Week 78 | Baseline, Week 78 | ITT was defined as all randomized participants who had received at least one dose of study treatment (Aducanumab or Placebo). 'Number of Participants Analyzed' signifies number of participants analyzed in this outcome measure. | score on a scale | MEAN |
Source ClinicalTrials.gov
Results by group12
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change From Baseline in Clinical Dementia Rating Sum of Boxes (CDR-SB) Score at Week 78 | Placebo (PC Period) | 1.56 | Standard Error 0.108 | score on a scale | |
| Change From Baseline in Clinical Dementia Rating Sum of Boxes (CDR-SB) Score at Week 78 | BIIB037 Low Dose (PC Period) | 1.38 | Standard Error 0.108 | score on a scale | |
| Change From Baseline in Clinical Dementia Rating Sum of Boxes (CDR-SB) Score at Week 78 | BIIB037 High Dose (PC Period) | 1.59 | Standard Error 0.111 | score on a scale | |
| Change From Baseline in Mini-Mental State Examination (MMSE) Score at Week 78 | Placebo (PC Period) | -3.5 | Standard Error 0.21 | score on a scale | |
| Change From Baseline in Mini-Mental State Examination (MMSE) Score at Week 78 | BIIB037 Low Dose (PC Period) | -3.3 | Standard Error 0.21 | score on a scale | |
| Change From Baseline in Mini-Mental State Examination (MMSE) Score at Week 78 | BIIB037 High Dose (PC Period) | -3.6 | Standard Error 0.21 | score on a scale | |
| Change From Baseline in Alzheimer's Disease Assessment Scale-Cognitive Subscale (13 Items) (ADAS-Cog 13) Score at Week 78 | Placebo (PC Period) | 5.140 | Standard Error 0.3783 | score on a scale | |
| Change From Baseline in Alzheimer's Disease Assessment Scale-Cognitive Subscale (13 Items) (ADAS-Cog 13) Score at Week 78 | BIIB037 Low Dose (PC Period) | 4.558 | Standard Error 0.3780 | score on a scale | |
| Change From Baseline in Alzheimer's Disease Assessment Scale-Cognitive Subscale (13 Items) (ADAS-Cog 13) Score at Week 78 | BIIB037 High Dose (PC Period) | 4.552 | Standard Error 0.3872 | score on a scale | |
| Change From Baseline in Alzheimer's Disease Cooperative Study-Activities of Daily Living Inventory (Mild Cognitive Impairment Version) (ADCS-ADL-MCI) Score at Week 78 | Placebo (PC Period) | -3.8 | Standard Error 0.35 | score on a scale |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 results by groupParticipant flow42
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Placebo-Controlled Period | STARTED | Placebo (PC Period) | 545 | |
| Placebo-Controlled Period | STARTED | BIIB037 Low Dose (PC Period) | 547 | |
| Placebo-Controlled Period | STARTED | BIIB037 High Dose (PC Period) | 555 | |
| Placebo-Controlled Period | STARTED | BIIB037 Late Start: Low Dose (LTE Period) | 0 | |
| Placebo-Controlled Period | STARTED | BIIB037 Late Start: High Dose (LTE Period) | 0 | |
| Placebo-Controlled Period | STARTED | BIIB037 Early Start: Low Dose (LTE Period) | 0 | |
| Placebo-Controlled Period | STARTED | BIIB037 Early Start: High Dose (LTE Period) | 0 | |
| Placebo-Controlled Period | COMPLETED | Placebo (PC Period) | 325 | |
| Placebo-Controlled Period | COMPLETED | BIIB037 Low Dose (PC Period) | 325 | |
| Placebo-Controlled Period | COMPLETED | BIIB037 High Dose (PC Period) | 288 |
1 to 10 of 42Source ClinicalTrials.gov
See all 42 participant flowAdverse events1,981
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 | Placebo (PC Period) | 44 | 540 | |
| other | Diarrhoea | Gastrointestinal disorders | BIIB037 Low Dose (PC Period) | 49 | 549 | |
| other | Diarrhoea | Gastrointestinal disorders | BIIB037 High Dose (PC Period) | 52 | 558 | |
| other | Diarrhoea | Gastrointestinal disorders | BIIB037 Late Start: Low Dose (LTE Period) | 6 | 150 | |
| other | Diarrhoea | Gastrointestinal disorders | BIIB037 Late Start: High Dose (LTE Period) | 8 | 152 | |
| other | Diarrhoea | Gastrointestinal disorders | BIIB037 Early Start: Low Dose (LTE Period) | 16 | 299 | |
| other | Diarrhoea | Gastrointestinal disorders | BIIB037 Early Start: High Dose (LTE Period) | 9 | 251 | |
| other | Nausea | Gastrointestinal disorders | Placebo (PC Period) | 42 | 540 | |
| other | Nausea | Gastrointestinal disorders | BIIB037 Low Dose (PC Period) | 30 | 549 | |
| other | Nausea | Gastrointestinal disorders | BIIB037 High Dose (PC Period) | 40 | 558 |
1 to 10 of 1,981Source ClinicalTrials.gov
See all 1,981 adverse eventsAdverse event totals21
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo (PC Period) | 0 | 540 |
| Total, all-cause mortality | BIIB037 Low Dose (PC Period) | 3 | 549 |
| Total, all-cause mortality | BIIB037 High Dose (PC Period) | 2 | 558 |
| Total, all-cause mortality | BIIB037 Late Start: Low Dose (LTE Period) | 1 | 150 |
| Total, all-cause mortality | BIIB037 Late Start: High Dose (LTE Period) | 1 | 152 |
| Total, all-cause mortality | BIIB037 Early Start: Low Dose (LTE Period) | 1 | 299 |
| Total, all-cause mortality | BIIB037 Early Start: High Dose (LTE Period) | 2 | 251 |
| Total, other adverse events | Placebo (PC Period) | 327 | 540 |
| Total, other adverse events | BIIB037 Low Dose (PC Period) | 396 | 549 |
| Total, other adverse events | BIIB037 High Dose (PC Period) | 410 | 558 |
1 to 10 of 21Source ClinicalTrials.gov
See all 21 adverse event totalsPapers5
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 comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests1
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 |
|---|---|
| Delayed Recall Module | Secondary outcome |
Source 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/NCT02477800
GET https://conductscience.org/api/trials/v1/NCT02477800/flow?page=2