Phase 2 Study of BIIB092 in Participants With Early Alzheimer's Disease



Status:Recruiting
Conditions:Alzheimer Disease
Therapuetic Areas:Neurology
Healthy:No
Age Range:50 - 80
Updated:2/6/2019
Start Date:May 3, 2018
End Date:July 9, 2021
Contact:US Biogen Clinical Trial Center
Email:clinicaltrials@biogen.com
Phone:866-633-4636

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Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Assess the Safety, Tolerability, and Efficacy of BIIB092 in Subjects With Mild Cognitive Impairment Due to Alzheimer's Disease or With Mild Alzheimer's Disease

To evaluate the safety and tolerability of BIIB092 in participants with mild cognitive
impairment (MCI) due to Alzheimer's disease (AD) or with mild AD. To evaluate the efficacy of
multiple doses of BIIB092 in slowing cognitive and functional impairment in participants with
MCI due to AD or with mild AD. To evaluate the immunogenicity of BIIB092 after multiple doses
in participants with MCI due to AD or with mild AD.


Key Inclusion Criteria:

- Must have a gradual and progressive change in memory function over more than 6 months.

- Must meet all of the clinical criteria for mild cognitive impairment (MCI) due to
Alzheimer's disease (AD) or mild AD and must have

- Objective evidence of cognitive impairment at Screening

- Clinical Dementia Rating Scale (CDR) global score of 0.5 for MCI due to AD or 0.5 or 1
for mild AD

- Mini-Mental State Examination (MMSE) score of 22 to 30 (inclusive)

- CDR Memory Box score of ≥0.5

- Must consent to apolipoprotein E (ApoE) genotyping

- Must have 1 informant/study partner

- Must have amyloid beta positivity confirmed at Screening

Key Exclusion Criteria:

- Any medical or neurological/neurodegenerative condition (other than AD) that, in the
opinion of the Investigator, might be a contributing cause to the participant's
cognitive impairment or could lead to discontinuation, lack of compliance,
interference with study assessments, or safety concerns

- Clinically significant, unstable psychiatric illness

- Have had a stroke or Transient Ischemic Attack (TIA) or unexplained loss of
consciousness in the past 1 year

- Relevant brain hemorrhage, bleeding disorder and cerebrovascular abnormalities

- History of unstable angina, myocardial infarction, chronic heart failure or clinically
significant conduction abnormalities within 1 year prior to Screening Visit 1

- Indication of impaired renal or liver function

- Alcohol or substance abuse in past 1 year

- Clinically significant systemic illness or serious infection within 30 days prior to
or during the screening period

- Use of allowed medications for chronic conditions at doses that have not been stable
for at least 4 weeks prior to Screening Visit 1 and during the screening period up to
Study Day 1, or use of AD medications at doses that have not been stable for at least
8 weeks prior to Screening Visit 1 and during the screening period up to Study Day 1.

- Use of any medications that, in the opinion of the Investigator, may contribute to
cognitive impairment, put the participants at higher risk for adverse events (AEs), or
impair the participant's ability to perform cognitive testing or complete study
procedures.

- Contraindications to study procedures

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply
We found this trial at
49
sites
104 SE 1st Avenue
Ocala, Florida 34471
352-629-5800
Principal Investigator: Anette Nieves
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9500 Euclid Avenue
Cleveland, Ohio 44106
216.444.2200
Principal Investigator: Babak Tousi
Phone: 216-636-2645
Cleveland Clinic Cleveland Clinic is committed to principles as presented in the United Nations Global...
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Cleveland, OH
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2919 Swann Avenue
Tampa, Florida 33609
813-353-9613
Principal Investigator: Susan Steen
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Anaheim, CA
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Atlanta, Georgia 30329
Principal Investigator: Allan Levey
Phone: 404-712-6855
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Atlanta, GA
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Atlantis, Florida 33462
Principal Investigator: Mark Goldstein
Phone: 561-968-2933
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Atlantis, FL
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115 Mill St
Belmont, Massachusetts 02478
(617) 855-2000
Principal Investigator: Oernubder Bhatia
Phone: 617-855-2589
McLean Hospital McLean Hospital is a comprehensive psychiatric hospital committed to providing easy access to...
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Belmont, MA
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Bennington, Vermont 05201
Principal Investigator: Cynthia Murphy
Phone: 802-447-1409
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Birmingham, AL
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Box Hill,
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Carlsbad, CA
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Cordova, Tennessee 38018
Principal Investigator: Lee Stein
Phone: 901-866-9252
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Delray Beach, Florida 33445
Principal Investigator: Mark Brody
Phone: 561-374-8461
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East Providence, Rhode Island 02914
Principal Investigator: John Stoukides
Phone: 401-435-8950
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East Providence, Rhode Island 02915
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Fairfax, VA
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Fairfield, Connecticut 06824
Principal Investigator: Srinath Kadimi
Phone: 203-877-1414
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Fort Myers, Florida 33912
Principal Investigator: Wendy Bond
Phone: 239-939-7777
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Fremont, California 94538
Principal Investigator: Puneet Chandak
Phone: 510-796-6000
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736 East Bullard Avenue
Fresno, California 93710
Principal Investigator: Perminder Bhatia
Phone: 559-437-9700
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Hanford, California 93230
Principal Investigator: Vladimir Royter
Phone: 559-584-9000
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Houston, TX
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Lancaster, CA
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Las Vegas, Nevada 89113
Principal Investigator: Bharat Mocherla
Phone: 702-750-0222
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Los Angeles, California 90095
Phone: 310-794-6191
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Methuen, Massachusetts 01844
Principal Investigator: Michael McCartney
Phone: 978-655-7155
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New Haven, CT
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Newport Beach, California 92658
Principal Investigator: William Shankle
Phone: 949-764-8394
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Orlando, Florida 32806
Principal Investigator: Christopher Galloway
Phone: 407-426-9299
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Phoenix, Arizona 85004
Principal Investigator: Stephen Flitman
Phone: 602-265-6500
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Phoenix, Arizona 85006
Principal Investigator: William Burke
Phone: 602-839-0588
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Plymouth, Massachusetts 02360
Principal Investigator: Donald Marks
Phone: 508-746-5060
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Port Orange, FL
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Rochester, New York 14620
Principal Investigator: Anton Porsteinsson
Phone: 585-760-6562
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San Diego, California 92103
Principal Investigator: Stephen Thein
Phone: 858-451-1016
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Santa Ana, California 92705
Principal Investigator: John Duffy
Phone: 714-542-3008
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Springfield, New Jersey 07081
Principal Investigator: Michelle Papka
Phone: 973-850-4622
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Stuart, FL
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Sun City, Arizona 85351
Principal Investigator: Edward Zamrini
Phone: 623-832-6526
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Toms River, New Jersey 08775
Principal Investigator: Sanjiv Sharma
Phone: 732-263-0101
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