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



Status:Recruiting
Conditions:Alzheimer Disease, Cognitive Studies, Neurology
Therapuetic Areas:Neurology, Psychiatry / Psychology
Healthy:No
Age Range:50 - 85
Updated:3/22/2019
Start Date:December 20, 2018
End Date:November 13, 2023
Contact:US Biogen Clinical Trial Center
Email:clinicaltrials@biogen.com
Phone:866-633-4636

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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

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.


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
We found this trial at
23
sites
Cordova, Tennessee 38018
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1200 Moursund Street
Houston, Texas 77030
(713) 798-4951
Baylor College of Medicine Baylor College of Medicine in Houston, the only private medical school...
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Houston, TX
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2450 E. River Road
Tucson, Arizona 85718
520-320-2147
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Atlantis, Florida 33462
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Austin, Texas 78757
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Austin, TX
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Columbus, GA
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Delray Beach, Florida 33445
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Fort Myers, FL
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Fullerton, California 92835
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Fullerton, CA
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Houston, Texas 77074
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Houston, TX
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Indianapolis, Indiana 46256
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Indianapolis, IN
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Las Vegas, Nevada 89113
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Las Vegas, NV
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Nedlands,
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3555 NW 58th St # 800
Oklahoma City, Oklahoma 73112
(405) 447-8839
Lynn Health Science Institute Our mission is to provide clinical trials research and health services...
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Oklahoma City, OK
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Orlando, Florida 32806
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Orlando, FL
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Oxnard, CA
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Phoenix, Arizona 85006
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Richmond, VA
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San Diego, California 92103
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San Diego, CA
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Sherman Oaks, CA
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Spokane, Washington 99202
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Spokane, WA
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The Villages, Florida 32162
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The Villages, FL
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Toms River, New Jersey 08757
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Toms River, NJ
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