Trial · NCT05310071

A Study to Verify the Clinical Benefit of Aducanumab in Participants With Early Alzheimer's Disease

NCT05310071, Phase 3, Terminated, Biogen; results first posted 2025-04-23

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. A Study to Verify the Clinical Benefit of Aducanumab in Participants With Early Alzheimer's Disease. Trials, record NCT05310071. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05310071

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: A Study to Verify the Clinical Benefit of Aducanumab in Participants With Early Alzheimer's Disease
NCT number: NCT05310071
Status: Terminated
Phases: Phase 3
Enrollment: 1,027 participants, actual
Lead sponsor: Biogen
Conditions: Alzheimer's Disease
Interventions: Aducanumab, Placebo
First posted: 2022-04-04
Last updated: 2025-04-23
Other registries' IDs: eudract:2022-001671-14
Results first posted: 2025-04-23
Limitations and caveats: The study was terminated prematurely based on the sponsor's decision.

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 in Clinical Dementia Rating Scale - Sum of Boxes (CDR-SB) Score at Week 78	Baseline, Week 78	The Clinical Dementia Rate Scale integrates assessments from 3 domains of cognition (memory, orientation, judgment/problem-solving) and 3 domains of function (community affairs, home/hobbies, personal care). Following the caregiver interview and systematic participant examination, the rater assigns a score describing the participant's current performance level in each of these domains of life functioning. The "Sum of boxes" scoring methodology sums the score for each of the 6 domains and provides a value ranging from 0 to 18. Higher scores indicate greater impairment. A positive change from baseline indicates greater impairment.
Secondary	Change From Baseline in Integrated Alzheimer's Disease Rating Scale (iADRS) Score at Weeks 78 and 106	Baseline, Weeks 78 and 106	The iADRS composite captures a decline in both cognition and daily function. It is a simple linear combination of the Alzheimer's disease assessment scale, cognitive subscale (ADAS-Cog13), and the Alzheimer's disease cooperative study scale for activities of daily living in mild cognitive impairment (ADCS-ADL-MCI). The ADAS-Cog13 scale ranges from 0 to 85 (higher scores indicate worse performance) and the ADCS-ADL-MCI scale ranges from 0 to 53 (higher scores indicate greater independent, healthy functioning). The total score for iADRS scale ranges from 0 to 138, where higher scores indicate better performance.
Secondary	Change From Baseline in Alzheimer's Disease Cooperative Study for Activities of Daily Living in Mild Cognitive Impairment (ADCS-ADL-MCI) Scale Score at Weeks 78 and 106	Baseline, Weeks 78 and 106	The ADCS-ADL-MCI scale consists of 17 instrumental items (e.g., shopping, preparing meals, using household appliances, etc) and 1 basic item (getting dressed). Ratings reflect caregiver observations about the participant'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. Higher scores indicate greater independent, healthy functioning. A positive change from baseline indicates healthy functioning while a negative change from baseline indicates a decline in independent functioning.
Secondary	Change From Baseline in Alzheimer's Disease Assessment Scale, Cognitive Subscale (ADAS-Cog13) at Weeks 78 and 106	Baseline, Weeks 78 and 106	ADAS-Cog13 comprises both cognitive tasks and clinical ratings of cognitive performance. The cognitive subscale 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. Higher scores indicate worse performance. A positive change from baseline indicates decline in cognitive performance.
Secondary	Change From Baseline in Mini-Mental State Examination (MMSE) Scale Score at Weeks 78 and 106	Baseline, Weeks 78 and 106	The MMSE scale is a 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. Higher scores indicate better performance. A negative change from baseline indicates decline in cognitive performance.
Secondary	Change From Baseline in Neuropsychiatric Inventory-10 (NPI-10) Score at Weeks 78 and 106	Baseline, Weeks 78 and 106	The NPI-10 is a questionnaire administered to the informant, designed to obtain information on the presence of neuropsychiatric symptoms and behaviors in a participant with Alzheimer's disease. Ten areas are assessed: delusions, hallucinations, agitation/aggression, depression, anxiety, elation/euphoria, apathy/indifference, disinhibition, irritability and aberrant motor behavior. The NPI total score ranges from 0 to 120. Higher scores indicate greater impairment. A negative change from baseline indicates improvement (symptom reduction).
Secondary	Change From Baseline in Amyloid Positron Emission Tomography (PET) Signal at Weeks 78 and 104	Baseline, Weeks 78 and 104	Amyloid PET scan assesses cerebral amyloid load using radiotracers which is standardized into centiloids. Centiloid values on centiloid scale is based on mean composite standardized uptake value ratio (SUVR).
Secondary	Change From Baseline in Tau PET Signal at Weeks 78 and 104	Baseline, Weeks 78 and 104	The cerebral tau level was measured by tau PET imaging. Tau PET imaging was conducted using radiotracer. SUVR is a ratio of PET uptake measured in brain region of interest and a disease-free reference region. A higher SUVR is an indication of increased PET radiotracer uptake and worsening disease.
Secondary	Change From Baseline in CDR-SB Score at Week 106	Baseline, Week 106	The CDR 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 participant examination, the rater assigns a score describing the participant's current performance level in each of these domains of life functioning. The CDR-SB sums the score for each of the 6 domains and provides a value ranging from 0 to 18. Higher scores indicate greater impairment. Positive change from baseline indicates greater impairment.
Secondary	Change From Baseline in Global Statistical Test (GST) Composite Z-Score at Weeks 78 and 106	Baseline, Weeks 78 and 106	GST z-score is an average of z-scores of CDR-SB, ADASCog13 and ADCS-ADL-MCI. CDR-SB assesses 3 cognitive (memory,orientation, judgment/problem-solving)and 3 functional(community affairs,home/hobbies,personal care) domains. Sum of Boxes method combines scores across 6 domains, ranging from 0-18(higher scores=greater impairment). ADAS-Cog13 evaluates cognitive tasks like word recall, naming, orientation and memory, with scores from 0-85 (higher scores=worse performance). ADCS-ADL-MCI rates 17 tasks (e.g.,shopping, preparing meal) and 1 basic task(dressing) with scores from 0-53 (higher scores=greater independence/healthy functioning). z-score\>0 indicates greater impairment/worse performance for CDR-SB and ADASCog13 scales and improved functioning for ADCS-ADL-MCI. For ADCS-ADL-MCI, z-score were reversed (new reversed value=original value-1) to make interpretation consistent. The GST z-score of 0 indicates population mean and score\>0 indicate greater impairment/worse performance.

Source ClinicalTrials.gov

Outcomes10

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 Scale - Sum of Boxes (CDR-SB) Score at Week 78	Baseline, Week 78	FAS included all randomized participants who had received at least 1 dose of study treatment (aducanumab or placebo). Here, 'overall number of participants analyzed' signifies the number of participants available for outcome measure analysis.	score on a scale	MEAN
SECONDARY	Change From Baseline in Integrated Alzheimer's Disease Rating Scale (iADRS) Score at Weeks 78 and 106	Baseline, Weeks 78 and 106	FAS included all randomized participants who had received at least 1 dose of study treatment (aducanumab or placebo). Here, 'overall number of participants analyzed' signifies the number of participants available for outcome measure analysis. Assessment was also planned for Week 106 for this outcome measure, but no assessments were conducted at Week 106 due to early termination.	score on a scale	MEAN
SECONDARY	Change From Baseline in Alzheimer's Disease Cooperative Study for Activities of Daily Living in Mild Cognitive Impairment (ADCS-ADL-MCI) Scale Score at Weeks 78 and 106	Baseline, Weeks 78 and 106	FAS included all randomized participants who had received at least 1 dose of study treatment (aducanumab or placebo). Here 'overall number of participants analyzed' signifies the number of participants available for outcome measure analysis. Assessment was also planned for Week 106 for this outcome measure, but no assessments were conducted at Week 106 due to early termination.	score on a scale	MEAN
SECONDARY	Change From Baseline in Alzheimer's Disease Assessment Scale, Cognitive Subscale (ADAS-Cog13) at Weeks 78 and 106	Baseline, Weeks 78 and 106	FAS included all randomized participants who had received at least 1 dose of study treatment (aducanumab or placebo). Here, 'overall number of participants analyzed' signifies the number of participants available for outcome measure analysis. Assessment was also planned for Week 106 for this outcome measure, but no assessments were conducted at Week 106 due to early termination.	score on a scale	MEAN
SECONDARY	Change From Baseline in Mini-Mental State Examination (MMSE) Scale Score at Weeks 78 and 106	Baseline, Weeks 78 and 106	FAS included all randomized participants who had received at least 1 dose of study treatment (aducanumab or placebo). Here, 'overall number of participants analyzed' signifies the number of participants available for outcome measure analysis. Assessment was also planned for Week 106 for this outcome measure, but no assessments were conducted at Week 106 due to early termination.	score on a scale	MEAN
SECONDARY	Change From Baseline in Neuropsychiatric Inventory-10 (NPI-10) Score at Weeks 78 and 106	Baseline, Weeks 78 and 106	FAS included all randomized participants who had received at least 1 dose of study treatment (aducanumab or placebo). Here, 'overall number of participants analyzed' signifies the number of participants available for outcome measure analysis. Assessment was also planned for Week 106 for this outcome measure, but no assessments were conducted at Week 106 due to early termination.	score on a scale	MEAN
SECONDARY	Change From Baseline in Amyloid Positron Emission Tomography (PET) Signal at Weeks 78 and 104	Baseline, Weeks 78 and 104	FAS included all randomized participants who had received at least 1 dose of study treatment (aducanumab or placebo). Here, 'overall number of participants analyzed' signifies the number of participants available for outcome measure analysis. Due to the decision of early termination, only one participant had an amyloid scan at week 78 and data was reported below. In addition, the assessment planned for Week 104 was not performed due to early termination.	SUVR	MEAN
SECONDARY	Change From Baseline in Tau PET Signal at Weeks 78 and 104	Baseline, Weeks 78 and 104	FAS included all randomized participants who had received at least 1 dose of study treatment (aducanumab or placebo). Here, 'overall number of participants analyzed' signifies the number of participants available for outcome measure analysis. Due to decision of early termination, the Tau PET scan was not performed in any participant at scheduled visits of Weeks 78 and 104.
SECONDARY	Change From Baseline in CDR-SB Score at Week 106	Baseline, Week 106	Assessment was planned for Week 106 for this outcome measure, but no assessments were conducted at Week 106 due to early termination.
SECONDARY	Change From Baseline in Global Statistical Test (GST) Composite Z-Score at Weeks 78 and 106	Baseline, Weeks 78 and 106	FAS included all randomized participants who had received at least 1 dose of study treatment (aducanumab or placebo). Here, 'overall number of participants analyzed' signifies the number of participants available for outcome measure analysis. Assessment was also planned for Week 106 for this outcome measure, but no assessments were conducted at Week 106 due to early termination.	z-score	MEAN

Source ClinicalTrials.gov

Results by group15

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
Change From Baseline in Clinical Dementia Rating Scale - Sum of Boxes (CDR-SB) Score at Week 78	Placebo	0.67	Standard Deviation 0.408	score on a scale
Change From Baseline in Clinical Dementia Rating Scale - Sum of Boxes (CDR-SB) Score at Week 78	Aducanumab	1.56	Standard Deviation 1.635	score on a scale
Change From Baseline in Integrated Alzheimer's Disease Rating Scale (iADRS) Score at Weeks 78 and 106	Placebo	-14.667	Standard Deviation 4.4869	score on a scale
Change From Baseline in Integrated Alzheimer's Disease Rating Scale (iADRS) Score at Weeks 78 and 106	Aducanumab	-7.796	Standard Deviation 6.7805	score on a scale
Change From Baseline in Alzheimer's Disease Cooperative Study for Activities of Daily Living in Mild Cognitive Impairment (ADCS-ADL-MCI) Scale Score at Weeks 78 and 106	Placebo	-5.0	Standard Deviation 3.61	score on a scale
Change From Baseline in Alzheimer's Disease Cooperative Study for Activities of Daily Living in Mild Cognitive Impairment (ADCS-ADL-MCI) Scale Score at Weeks 78 and 106	Aducanumab	-0.4	Standard Deviation 7.60	score on a scale
Change From Baseline in Alzheimer's Disease Assessment Scale, Cognitive Subscale (ADAS-Cog13) at Weeks 78 and 106	Placebo	9.667	Standard Deviation 0.8844	score on a scale
Change From Baseline in Alzheimer's Disease Assessment Scale, Cognitive Subscale (ADAS-Cog13) at Weeks 78 and 106	Aducanumab	7.396	Standard Deviation 2.3262	score on a scale
Change From Baseline in Mini-Mental State Examination (MMSE) Scale Score at Weeks 78 and 106	Placebo	-6.0	Standard Deviation 1.00	score on a scale
Change From Baseline in Mini-Mental State Examination (MMSE) Scale Score at Weeks 78 and 106	Aducanumab	-1.2	Standard Deviation 1.48	score on a scale

1 to 10 of 15Source ClinicalTrials.gov

See all 15 results by group

Participant flow6

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Placebo	344
Overall Study	STARTED	Aducanumab	680
Overall Study	COMPLETED	Placebo	0
Overall Study	COMPLETED	Aducanumab	0
Overall Study	NOT COMPLETED	Placebo	344
Overall Study	NOT COMPLETED	Aducanumab	680

Source ClinicalTrials.gov

Adverse events170

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
other	Covid-19	Infections and infestations	Placebo	19	343
other	Covid-19	Infections and infestations	Aducanumab	49	681
other	Nasopharyngitis	Infections and infestations	Placebo	26	343
other	Nasopharyngitis	Infections and infestations	Aducanumab	42	681
other	Fall	Injury, poisoning and procedural complications	Placebo	32	343
other	Fall	Injury, poisoning and procedural complications	Aducanumab	55	681
other	Amyloid related imaging abnormality-microhaemorrhages and haemosiderin deposits	Nervous system disorders	Placebo	34	343
other	Amyloid related imaging abnormality-microhaemorrhages and haemosiderin deposits	Nervous system disorders	Aducanumab	167	681
other	Amyloid related imaging abnormality-oedema/effusion	Nervous system disorders	Placebo	8	343
other	Amyloid related imaging abnormality-oedema/effusion	Nervous system disorders	Aducanumab	159	681

1 to 10 of 170Source ClinicalTrials.gov

See all 170 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Placebo	0	343
Total, all-cause mortality	Aducanumab	3	681
Total, other adverse events	Placebo	127	343
Total, other adverse events	Aducanumab	359	681
Total, serious adverse events	Placebo	23	343
Total, serious adverse events	Aducanumab	59	681

Source ClinicalTrials.gov

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 comparisons2

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
Aducanumab vs Placebo: deaths from any cause	Trial comparisons
Aducanumab vs Placebo: serious adverse events	Trial comparisons

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.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

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/NCT05310071

GET https://conductscience.org/api/trials/v1/NCT05310071/events?page=2

API reference For AI assistants