Trial · NCT04241068
A Study to Evaluate Safety and Tolerability of Aducanumab in Participants With Alzheimer's Disease Who Had Previously Participated in the Aducanumab Studies 221AD103, 221AD301, 221AD302 and 221AD205
NCT04241068, Phase 3, Terminated, Biogen; results first posted 2025-02-21
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study to Evaluate Safety and Tolerability of Aducanumab in Participants With Alzheimer's Disease Who Had Previously Participated in the Aducanumab Studies 221AD103, 221AD301, 221AD302 and 221AD205. Trials, record NCT04241068. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04241068
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study to Evaluate Safety and Tolerability of Aducanumab in Participants With Alzheimer's Disease Who Had Previously Participated in the Aducanumab Studies 221AD103, 221AD301, 221AD302 and 221AD205
- NCT number
- NCT04241068
- Status
- Terminated
- Phases
- Phase 3
- Enrollment
- 1,696 participants, actual
- Lead sponsor
- Biogen
- Conditions
- Alzheimer's Disease
- Interventions
- Aducanumab
- First posted
- 2020-01-27
- Last updated
- 2025-02-21
- Other registries' IDs
- eudract:2019-004368-22
- Results first posted
- 2025-02-21
- Limitations and caveats
- The study was terminated prematurely based on the sponsor's decision.
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Core Treatment Period: Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious TEAEs | From the first dose of study drug to end of follow-up (up to Week 118) | An AE is any untoward medical occurrence in a participant/clinical investigation participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. An AE can be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with use of medicinal(investigational) product, whether or not related to medicinal (investigational) product. An SAE is any untoward medical occurrence that at any dose results in death, is a life-threatening event, requires inpatient hospitalization or prolongation of existing hospitalization, results in significant disability/incapacity or congenital anomaly, is medically important event. TEAE or Serious TEAEs are defined as any AE that has an onset date and time that is on or after date and time of first dose of study treatment, or that has worsened after date and time of first dose of study treatment. |
| Primary | Core Treatment Period: Number of Participants With AEs Leading to Treatment Discontinuation (TD) and Study Withdrawal (SW) | From the first dose of study drug to end of follow-up (up to Week 118) | An AE is any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. |
| Primary | Core Treatment Period: Number of Participants With Amyloid-Related Imaging Abnormality-Edema (ARIA-E) | Up to Week 118 | Number of participants diagnosed with ARIA edema are reported. |
| Primary | Core Treatment Period: Number of Participants With Amyloid-Related Imaging Abnormality- Hemorrhage or Superficial Siderosis (ARIA-H) | Up to Week 118 | Number of participants diagnosed with ARIA hemmorrhage or superficial siderosis are reported. |
| Primary | Core Treatment Period: Number of Participants With Positive Antidrug Antibodies (ADAs) in Serum | Up to Week 102 | The presence of serum ADAs was determined using a validated assay. A standard 3-tiered approach was used including screening assay, confirmatory assay, and titration assay. The number of participants with a positive response to ADAs are reported. |
Source ClinicalTrials.gov
Outcomes5
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Core Treatment Period: Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious TEAEs | From the first dose of study drug to end of follow-up (up to Week 118) | The safety population for the core period included all participants who had received at least one dose of aducanumab in the core period. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Core Treatment Period: Number of Participants With AEs Leading to Treatment Discontinuation (TD) and Study Withdrawal (SW) | From the first dose of study drug to end of follow-up (up to Week 118) | The safety population for the core period included all participants who had received at least one dose of aducanumab in the core period. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Core Treatment Period: Number of Participants With Amyloid-Related Imaging Abnormality-Edema (ARIA-E) | Up to Week 118 | The safety magnetic resonance imaging (MRI) population for the core period included all participants who had received at least one dose of aducanumab in the core period and had at least one post-baseline MRI assessment in the core period. Here, 'overall number of participants analyzed' signifies the number of participants with data available for outcome measure analysis. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Core Treatment Period: Number of Participants With Amyloid-Related Imaging Abnormality- Hemorrhage or Superficial Siderosis (ARIA-H) | Up to Week 118 | The safety MRI population for the core period included all participants who had received at least one dose of aducanumab in the core period and had at least one post-baseline MRI assessment in the core period. Here, 'overall number of participants analyzed' signifies the number of participants with data available for outcome measure analysis. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Core Treatment Period: Number of Participants With Positive Antidrug Antibodies (ADAs) in Serum | Up to Week 102 | The immunogenicity population for the core period included all participants who had received at least one dose of aducanumab in the core period and had at least one post-dose sample evaluated for immunogenicity in the core period. Here, 'overall number of participants analyzed' signifies the number of participants with data available for outcome measure analysis. | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group7
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Core Treatment Period: Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious TEAEs | Aducanumab | TEAEs | 1549 | Participants | |
| Core Treatment Period: Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious TEAEs | Aducanumab | Serious TEAEs | 318 | Participants | |
| Core Treatment Period: Number of Participants With AEs Leading to Treatment Discontinuation (TD) and Study Withdrawal (SW) | Aducanumab | AEs leading to TD | 168 | Participants | |
| Core Treatment Period: Number of Participants With AEs Leading to Treatment Discontinuation (TD) and Study Withdrawal (SW) | Aducanumab | AEs leading to SW | 129 | Participants | |
| Core Treatment Period: Number of Participants With Amyloid-Related Imaging Abnormality-Edema (ARIA-E) | Aducanumab | 422 | Participants | ||
| Core Treatment Period: Number of Participants With Amyloid-Related Imaging Abnormality- Hemorrhage or Superficial Siderosis (ARIA-H) | Aducanumab | 505 | Participants | ||
| Core Treatment Period: Number of Participants With Positive Antidrug Antibodies (ADAs) in Serum | Aducanumab | 19 | Participants |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Core Treatment Period | STARTED | Aducanumab | 1,696 | |
| Core Treatment Period | COMPLETED | Aducanumab | 1,118 | |
| Core Treatment Period | NOT COMPLETED | Aducanumab | 578 | |
| LTE Period | STARTED | Aducanumab | 1,041 | |
| LTE Period | COMPLETED | Aducanumab | 508 | |
| LTE Period | NOT COMPLETED | Aducanumab | 533 |
Source ClinicalTrials.gov
Adverse events318
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 | Constipation | Gastrointestinal disorders | Aducanumab | 87 | 1,696 | |
| other | Diarrhoea | Gastrointestinal disorders | Aducanumab | 130 | 1,696 | |
| other | Fatigue | General disorders | Aducanumab | 98 | 1,696 | |
| other | Covid-19 | Infections and infestations | Aducanumab | 427 | 1,696 | |
| other | Nasopharyngitis | Infections and infestations | Aducanumab | 107 | 1,696 | |
| other | Urinary tract infection | Infections and infestations | Aducanumab | 122 | 1,696 | |
| other | Contusion | Injury, poisoning and procedural complications | Aducanumab | 92 | 1,696 | |
| other | Fall | Injury, poisoning and procedural complications | Aducanumab | 355 | 1,696 | |
| other | Weight decreased | Investigations | Aducanumab | 91 | 1,696 | |
| other | Arthralgia | Musculoskeletal and connective tissue disorders | Aducanumab | 158 | 1,696 |
1 to 10 of 318Source ClinicalTrials.gov
See all 318 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Aducanumab | 37 | 1,696 |
| Total, other adverse events | Aducanumab | 1,351 | 1,696 |
| Total, serious adverse events | Aducanumab | 416 | 1,696 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 42841310 | DERIVED |
Source PubMed
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/NCT04241068
GET https://conductscience.org/api/trials/v1/NCT04241068/events?page=2