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

NCT03639987 | Terminated Phase 2 Results DMC FDA Drug

• 2 other identifiers: 221AD2052018-002102-31
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 22

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.

Conditions

Cognitive Dysfunction; Alzheimer's Disease

Keywords

Aducanumab; BIIB037

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Clinically Impactful Amyloid-related Imaging Abnormalities (ARIA)

  up to Week 54

Secondary Outcomes (10)

• Number of Participants With ARIA by Severity as Obtained on Magnetic Resonance Imaging (MRI)

  up to Week 54

• Time to Onset of ARIA as Obtained on MRI

  up to Week 54

• Time to Resolution of ARIA as Obtained on MRI

  up to Week 54

• Number of Participants With Symptomatic ARIA by Severity

  up to Week 54

• Time to Onset of Symptomatic ARIA

  up to Week 54

Study Arms (2)

Group 1

EXPERIMENTAL

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; Drug: Placebo

Group 2

EXPERIMENTAL

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

Interventions

Aducanumab DRUG

Administered as specified in the treatment arm.

Also known as: BIIB037

Group 1; Group 2

Placebo DRUG

Administered as specified in the treatment arm.

Group 1

Eligibility Criteria

• Age: 50 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• 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 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)).
• 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.

Sponsors & Collaborators

• Biogen: lead

Study Sites (22)

Banner Alzheimer's Institute

Phoenix, Arizona, 85006, United States

Location

Center for Neurosciences

Tucson, Arizona, 85718, United States

Location

Neurology Center of North Orange County

Fullerton, California, 92835, United States

Location

Pacific Neuroscience Medical Group

Oxnard, California, 93030, United States

Location

Pacific Research Network, Inc

San Diego, California, 92103, United States

Location

California Neuroscience Research Medical Group Inc.

Sherman Oaks, California, 91403, United States

Location

JEM Research Institute

Atlantis, Florida, 33462, United States

Location

Brain Matters Research

Delray Beach, Florida, 33445, United States

Location

Neuropsychiatric Research Center of Southwest Florida

Fort Myers, Florida, 33912, United States

Location

Bioclinica Orlando

Orlando, Florida, 32806, United States

Location

Bioclinica Orlando

The Villages, Florida, 32162, United States

Location

Medical Research Health and Education Foundation, Inc

Columbus, Georgia, 31909, United States

Location

Josephson, Wallack, Munshower Neurology, P.C.

Indianapolis, Indiana, 46256, United States

Location

Las Vegas Medical Research

Las Vegas, Nevada, 89113, United States

Location

Advanced Memory Research Institute of NJ, PC

Toms River, New Jersey, 08755, United States

Location

Lynn Health Science Institute

Oklahoma City, Oklahoma, 73112, United States

Location

Neurology Clinic, PC

Cordova, Tennessee, 38108, United States

Location

Senior Adult Specialty Research

Austin, Texas, 78757, United States

Location

Baylor College Of Medicine

Houston, Texas, 77030, United States

Location

Clinical Trial Network

Houston, Texas, 77074, United States

Location

National Clinical Research Inc.-Richmond

Richmond, Virginia, 23294, United States

Location

Kingfisher Cooperative, LLC

Spokane, Washington, 99202, United States

Location

MeSH Terms

Conditions

Cognitive Dysfunction; Alzheimer Disease

Interventions

aducanumab

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders; Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases

Limitations and Caveats

Study was discontinued based on futility analysis conducted on Phase 3 trials (NCT02477800 and NCT02484547). Enrolment and dosing was halted immediately upon the study termination announcement.

Results Point of Contact

• Title: US Biogen Clinical Trial Center
• Organization: Biogen

clinicaltrials@biogen.com

866-633-4636

Study Officials

• Medical Director

  Biogen

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 17, 2018
• First Posted: August 21, 2018
• Study Start: December 20, 2018
• Primary Completion: July 30, 2019
• Study Completion: July 30, 2019
• Last Updated: September 16, 2021
• Results First Posted: September 16, 2021

Record last verified: 2021-08

Locations

US (22)