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A Study of Aducanumab in Participants With Mild Cognitive Impairment Due to Alzheimer's Disease or With Mild Alzheimer's Disease Dementia to Evaluate the Safety of Continued Dosing in Participants With Asymptomatic Amyloid-Related Imaging Abnormalities (EVOLVE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03639987
Recruitment Status : Terminated (Study was discontinued based on futility analysis conducted on Phase 3 trials (NCT02477800 and NCT02484547) and not based on safety concerns.)
First Posted : August 21, 2018
Results First Posted : September 16, 2021
Last Update Posted : September 16, 2021
Sponsor:
Information provided by (Responsible Party):
Biogen

Study Description
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Brief Summary:
The primary objective of the study is to assess the safety impact of continuing aducanumab dosing in asymptomatic Amyloid-related Imaging Abnormalities (ARIA) in participants with mild cognitive impairment (MCI) due to Alzheimer's disease (AD) or with mild AD dementia. The secondary objective of the study is to characterize ARIA, from both the imaging and the clinical perspective and to characterize the safety, tolerability, pharmacokinetics (PK), and immunogenicity of aducanumab.

Condition or disease Intervention/treatment Phase
Cognitive Dysfunction Alzheimer's Disease Drug: Aducanumab Drug: Placebo Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 52 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 2, Multicenter, Randomized, Parallel-Group, Double-Blind, Controlled Study of Aducanumab (BIIB037) in Subjects With Mild Cognitive Impairment Due to Alzheimer's Disease or With Mild Alzheimer's Disease Dementia to Evaluate the Safety of Continued Dosing in Subjects With Asymptomatic Amyloid-Related Imaging Abnormalities
Actual Study Start Date : December 20, 2018
Actual Primary Completion Date : July 30, 2019
Actual Study Completion Date : July 30, 2019

Resource links provided by the National Library of Medicine

Drug Information available for: Aducanumab

Arms and Interventions
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Arm Intervention/treatment
Experimental: Group 1
Aducanumab, intravenous infusion, every 4 weeks for up to Week 52 during the randomized treatment period. The dose will be titrated to a desirable dose. Participants will be managed for drug continuation and suspension. Following a 4-week follow-up period, eligible participants will continue to receive aducanumab, intravenous infusion, every 4 weeks for an additional 104 weeks in the long-term extension period.
 Drug: Aducanumab
Administered as specified in the treatment arm.
Other Name: BIIB037

Drug: Placebo
Administered as specified in the treatment arm.
Experimental: Group 2
Aducanumab, intravenous infusion, every 4 weeks for up to Week 52 during the randomized treatment period. The dose will be titrated to a desirable dose. Participants will be managed for drug continuation and suspension. Following a 4-week follow-up period, eligible participants will continue to receive aducanumab, intravenous infusion, every 4 weeks for an additional 104 weeks in the long-term extension period.
 Drug: Aducanumab
Administered as specified in the treatment arm.
Other Name: BIIB037


Outcome Measures
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Primary Outcome Measures :
  1. Number of Participants With Clinically Impactful Amyloid-related Imaging Abnormalities (ARIA) [ Time Frame: up to Week 54 ]

Secondary Outcome Measures :
  1. Number of Participants With ARIA by Severity as Obtained on Magnetic Resonance Imaging (MRI) [ Time Frame: up to Week 54 ]
    ARIA by severity was obtained on Magnetic Resonance Imaging (MRI).

  2. Time to Onset of ARIA as Obtained on MRI [ Time Frame: up to Week 54 ]
  3. Time to Resolution of ARIA as Obtained on MRI [ Time Frame: up to Week 54 ]
  4. Number of Participants With Symptomatic ARIA by Severity [ Time Frame: up to Week 54 ]
    ARIA by severity was obtained on Magnetic Resonance Imaging (MRI).

  5. Time to Onset of Symptomatic ARIA [ Time Frame: up to Week 54 ]
  6. Time to Resolution of Symptomatic ARIA [ Time Frame: up to Week 54 ]
  7. Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) [ Time Frame: up to Week 54 ]
    An AE is any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. An SAE is any untoward medical occurrence that at any dose: results in death, in the view of the Investigator, places the participant at immediate risk of death (a life-threatening event), however, this does not include an event that, had it occurred in a more severe form, might have caused death; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; results in a congenital anomaly/birth defect or is a medically important event.

  8. Change From Baseline in the Montreal Cognitive Assessment (MoCA) at Week 54 [ Time Frame: Baseline, Week 54 ]
  9. Number of Participants With Aducanumab Concentration in Serum [ Time Frame: up to Week 54 ]
  10. Number of Participants With Antiaducanumab Antibodies in Serum [ Time Frame: up to Week 54 ]

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion/ Exclusion Criteria

Key Inclusion Criteria:

  • Ability of the participant or his/her legally authorized representative to understand the purpose and risks of the study and provide signed and dated informed consent and authorization to use confidential health information in accordance with national and local participant privacy regulations.
  • Must have at least 6 years of education or work experience to exclude mental deficits other than MCI due to AD or mild AD dementia.
  • Must have evidence of cerebral Aβ accumulation, based on a positive PET scan of the brain. Previously obtained positron emission tomography (PET) scan (within 12 months of screening) is permissible. Previous PET scan images must be submitted to the central imaging vendor to confirm that study inclusion criteria are met.
  • Must consent to apolipoprotein E (ApoE) genotyping.
  • Must meet all of the following clinical criteria for MCI due to AD or mild AD dementia according to NIA-AA criteria [Albert 2011; McKhann 2011], and must have the following: MCI due to AD (a CDR global score of 0.5, and an MMSE score between 24 and 30 (inclusive)), or Mild AD dementia (a CDR global score of 0.5 or 1, and as MMSE score between 20 and 26 (inclusive)).

Key Exclusion Criteria:

  • Any uncontrolled medical or neurological/neurodegenerative condition (other than AD) that, in the opinion of the Investigator, might be a contributing cause of the participant's cognitive impairment (e.g., substance abuse, vitamin B12 deficiency, abnormal thyroid function, stroke or other cerebrovascular condition, Lewy body dementia, frontotemporal dementia, head trauma).
  • Clinically significant unstable psychiatric illness (e.g., uncontrolled major depression, uncontrolled schizophrenia, uncontrolled bipolar affective disorder) within 6 months prior to Screening.
  • Transient ischemic attack or stroke or any unexplained loss of consciousness within 1 year prior to Screening.
  • Vaccinations within 10 days prior to randomization (Day 1).
  • Female participants who are pregnant or currently breastfeeding.

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03639987


Locations
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Sponsors and Collaborators
Biogen
Investigators
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Study Director: Medical Director Biogen
  Study Documents (Full-Text)

Documents provided by Biogen:
Study Protocol  [PDF] July 6, 2018
Statistical Analysis Plan  [PDF] May 29, 2019

More Information
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Responsible Party: Biogen
ClinicalTrials.gov Identifier: NCT03639987    
Other Study ID Numbers: 221AD205
2018-002102-31 ( EudraCT Number )
First Posted: August 21, 2018    Key Record Dates
Results First Posted: September 16, 2021
Last Update Posted: September 16, 2021
Last Verified: August 2021

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Biogen:
Aducanumab
BIIB037
Additional relevant MeSH terms:
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Alzheimer Disease
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurodegenerative Diseases
Neurocognitive Disorders
 Mental Disorders
Cognition Disorders
Dementia
Cognitive Dysfunction
Tauopathies