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
Stopped early · Phase 2 · Has a placebo group
Conditions studied: Cognitive Dysfunction, Alzheimer's Disease
In brief
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.
Key facts
- Study ID
- NCT03639987
- Run by
- Biogen
- People needed
- 52
- Starts
- 2018-12-20
- Expected to finish
- 2019-07-30
- Last updated by the study team
- 2021-09-16
Who can join
Age: 50 and older, up to 85. Sex: any. Healthy volunteers: not accepted.
Where it is running
- Banner Alzheimer's Institute — Phoenix, Arizona, United States
- Center for Neurosciences — Tucson, Arizona, United States
- Neurology Center of North Orange County — Fullerton, California, United States
- Pacific Neuroscience Medical Group — Oxnard, California, United States
- Pacific Research Network, Inc — San Diego, California, United States
- California Neuroscience Research Medical Group Inc. — Sherman Oaks, California, United States
- JEM Research Institute — Atlantis, Florida, United States
- Brain Matters Research — Delray Beach, Florida, United States
- Neuropsychiatric Research Center of Southwest Florida — Fort Myers, Florida, United States
- Bioclinica Orlando — Orlando, Florida, United States
- Bioclinica Orlando — The Villages, Florida, United States
- Medical Research Health and Education Foundation, Inc — Columbus, Georgia, United States
- Josephson, Wallack, Munshower Neurology, P.C. — Indianapolis, Indiana, United States
- Las Vegas Medical Research — Las Vegas, Nevada, United States
- Advanced Memory Research Institute of NJ, PC — Toms River, New Jersey, United States
- Lynn Health Science Institute — Oklahoma City, Oklahoma, United States
- Neurology Clinic, PC — Cordova, Tennessee, United States
- Senior Adult Specialty Research — Austin, Texas, United States
- Baylor College Of Medicine — Houston, Texas, United States
- Clinical Trial Network — Houston, Texas, United States
- National Clinical Research Inc.-Richmond — Richmond, Virginia, United States
- Kingfisher Cooperative, LLC — Spokane, Washington, United States
Full record on ClinicalTrials.gov
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