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 | 
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.
			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
	
								San Diego, California 92103			
	
			
					Principal Investigator: Stephen Thein
			
						
										Phone: 858-451-1016
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									9500 Euclid Avenue
Cleveland, Ohio 44106
	
			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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									104 SE 1st Avenue
Ocala, Florida 34471
	
			Ocala, Florida 34471
352-629-5800
							 
					Principal Investigator: Anette Nieves
			
						
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									2919 Swann Avenue
Tampa, Florida 33609
	
			Tampa, Florida 33609
813-353-9613
							 
					Principal Investigator: Susan Steen
			
						
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								Atlanta, Georgia 30329			
	
			
					Principal Investigator: Allan Levey
			
						
										Phone: 404-712-6855
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								Atlantis, Florida 33462			
	
			
					Principal Investigator: Mark Goldstein
			
						
										Phone: 561-968-2933
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									115 Mill St
Belmont, Massachusetts 02478
	
			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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								Bennington, Vermont 05201			
	
			
					Principal Investigator: Cynthia Murphy
			
						
										Phone: 802-447-1409
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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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								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
	
			
					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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								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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								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 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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								Rochester, New York 14620			
	
			
					Principal Investigator: Anton Porsteinsson
			
						
										Phone: 585-760-6562
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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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								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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