A Study of LY3372993 in Healthy Participants and Participants With Alzheimer's Disease (AD)
| Status: | Recruiting | 
|---|---|
| Conditions: | Alzheimer Disease | 
| Therapuetic Areas: | Neurology | 
| Healthy: | No | 
| Age Range: | 18 - 85 | 
| Updated: | 3/21/2019 | 
| Start Date: | November 5, 2018 | 
| End Date: | September 7, 2021 | 
| Contact: | There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or | 
| Email: | ClinicalTrials.gov@Lilly.com | 
| Phone: | 1-317-615-4559 | 
A Single-Dose and Multiple-Dose, Dose-Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of LY3372993 in Healthy Subjects and Patients With Alzheimer's Disease
The main purpose of this study is to evaluate the safety and tolerability of LY3372993 in
healthy participants and participants with AD. The study will also investigate how much
LY3372993 gets into the bloodstream and test the effects of LY3372993 in participants with
AD.
The study has two parts:
- Part A - Healthy participants will receive LY3372993 or placebo. Part A will last up to
17 weeks;
- Part B - Participants with AD will receive LY3372993 or placebo. Part B will last about
317 days.
			healthy participants and participants with AD. The study will also investigate how much
LY3372993 gets into the bloodstream and test the effects of LY3372993 in participants with
AD.
The study has two parts:
- Part A - Healthy participants will receive LY3372993 or placebo. Part A will last up to
17 weeks;
- Part B - Participants with AD will receive LY3372993 or placebo. Part B will last about
317 days.
Inclusion Criteria :
Part A:
- Overtly healthy males or females as determined by medical history and physical
examination
- Are between 18 to 45 years old, inclusive
- Male participants agree to use a reliable method of birth control during the study and
3 months following the last dose of the investigational product
- Female participants not of child-bearing potential
- Have a body mass index of 18.0 to 32 kilograms per square meter (kg/m²) inclusive
Part B:
- Present with mild cognitive impairment (MCI) due to Alzheimer's disease (AD) or
mild-to-moderate AD
- Positive florbetapir scan
- Men or nonfertile women, at least 55 years of age. Nonfertile is defined as
hysterectomy and/or bilateral oophorectomy, or amenorrhea for at least 1 year
- Have up to 2 study partners who can provide health information related to the study
about the participant. Study partner(s) will provide a separate written informed
consent to participate
Exclusion Criteria:
- Have significant abnormalities in brain magnetic resonance imaging (MRI); or have
contraindications for MRI
- Have significant allergic reactions to LY3372993, or related compounds, or have
significant allergies to humanized monoclonal antibodies, diphenhydramine,
epinephrine, or methylprednisolone
- Have clinically significant neurological or psychological illness, or other illnesses
that could affect the study results
Part A:
- Have family history of early onset Alzheimer's Disease (AD)
- Have impaired cognitive function
Part B:
- History of intracranial hemorrhage, cerebrovascular aneurysm or arteriovenous
malformation, or carotid artery occlusion, or stroke or epilepsy
- Previously dosed in any other study investigating active immunization against amyloid
beta (Aβ)
- Previously dosed in any other study investigating passive immunization against Aβ
within the last 6 months
- Have current serious or unstable illnesses
We found this trial at
    11
    sites
	
									811 Juniper St NE
Atlanta, Georgia 30308
	
			Atlanta, Georgia 30308
(404) 881-5800
							
					Principal Investigator: Maria A Johnson
			
						
										Phone: 404-881-5800
					
		Atlanta Center for Medical Research Welcome to the Atlanta Center for Medical Research, a leader...  
  
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									860 Peachwood Drive
DeLand, Florida 32720
	
			DeLand, Florida 32720
(386) 740-0770
							
					Principal Investigator: Bruce G. Rankin
			
						
										Phone: 386-785-2400
					
		Site Overview Avail Clinical Research is a renowned and experienced clinical research site conducting Phase...  
  
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									911 E. Hallandale Beach Blvd
Hallandale Beach, Florida 33009
	
			Hallandale Beach, Florida 33009
954-455-5757
							
					Principal Investigator: Beth Safirstein
			
						
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								Daytona Beach, Florida 32117			
	
			
					Principal Investigator: Lawrence A Galitz
			
						
										Phone: 386-366-6490
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								Long Beach, California 90806			
	
			
					Principal Investigator: Omid Omidvar
			
						
										Phone: 916-939-6696
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									100 West Gore Street
Orlando, Florida 32806
	
			
					Orlando, Florida 32806
Principal Investigator: George Stoica
			
						
										Phone: 407-841-0502
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								Port Orange, Florida 32127			
	
			
					Principal Investigator: Alexander J White
			
						
										Phone: 386-304-7070
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								Raleigh, North Carolina 27612			
	
			
					Principal Investigator: Singar Jagadeesan
			
						
										Phone: 919-781-2514
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								Salt Lake City, Utah 84106			
	
			
					Principal Investigator: Shawn Searle
			
						
										Phone: 801-269-8200
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