Clinical trial NCT03639987: 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
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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Cognitive Dysfunction
Alzheimer's Disease
Keywords: Aducanumab
BIIB037
Lead sponsor: Biogen
Sponsor class: INDUSTRY
First posted: 2018-08-21
Enrollment: 52
Sex: ALL
Minimum age (years): 50
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Number of Participants With Clinically Impactful Amyloid-related Imaging Abnormalities (ARIA)
timeFrame: up to Week 54
Secondary outcomes:
measure: Number of Participants With ARIA by Severity as Obtained on Magnetic Resonance Imaging (MRI)
timeFrame: up to Week 54
measure: Time to Onset of ARIA as Obtained on MRI
timeFrame: up to Week 54
measure: Time to Resolution of ARIA as Obtained on MRI
timeFrame: up to Week 54
measure: Number of Participants With Symptomatic ARIA by Severity
timeFrame: up to Week 54
measure: Time to Onset of Symptomatic ARIA
timeFrame: up to Week 54
measure: Time to Resolution of Symptomatic ARIA
timeFrame: up to Week 54
measure: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
timeFrame: up to Week 54
measure: Change From Baseline in the Montreal Cognitive Assessment (MoCA) at Week 54
timeFrame: Baseline, Week 54
measure: Number of Participants With Aducanumab Concentration in Serum
timeFrame: up to Week 54
measure: Number of Participants With Antiaducanumab Antibodies in Serum
timeFrame: up to Week 54
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Banner Alzheimer's Institute
state: Arizona
city: Tucson
country: United States
facility: Center for Neurosciences
state: Arizona
city: Fullerton
country: United States
facility: Neurology Center of North Orange County
state: California
city: Oxnard
country: United States
facility: Pacific Neuroscience Medical Group
state: California
city: San Diego
country: United States
facility: Pacific Research Network, Inc
state: California
city: Sherman Oaks
country: United States
facility: California Neuroscience Research Medical Group Inc.
state: California
city: Atlantis
country: United States
facility: JEM Research Institute
state: Florida
city: Delray Beach
country: United States
facility: Brain Matters Research
state: Florida
city: Fort Myers
country: United States
facility: Neuropsychiatric Research Center of Southwest Florida
state: Florida
city: Orlando
country: United States
facility: Bioclinica Orlando
state: Florida
city: The Villages
country: United States
facility: Bioclinica Orlando
state: Florida
city: Columbus
country: United States
facility: Medical Research Health and Education Foundation, Inc
state: Georgia
city: Indianapolis
country: United States
facility: Josephson, Wallack, Munshower Neurology, P.C.
state: Indiana
city: Las Vegas
country: United States
facility: Las Vegas Medical Research
state: Nevada
city: Toms River
country: United States
facility: Advanced Memory Research Institute of NJ, PC
state: New Jersey
city: Oklahoma City
country: United States
facility: Lynn Health Science Institute
state: Oklahoma
city: Cordova
country: United States
facility: Neurology Clinic, PC
state: Tennessee
city: Austin
country: United States
facility: Senior Adult Specialty Research
state: Texas
city: Houston
country: United States
facility: Baylor College Of Medicine
state: Texas
city: Houston
country: United States
facility: Clinical Trial Network
state: Texas
city: Richmond
country: United States
facility: National Clinical Research Inc.-Richmond
state: Virginia
city: Spokane
country: United States
facility: Kingfisher Cooperative, LLC
state: Washington
Study officials:
affiliation: Biogen
name: Medical Director
role: STUDY_DIRECTOR
References: