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LY3372993 in Healthy Participants and People with Alzheimer's

Start: November 5, 2018
End: May 14, 2019
Enrollment: 100

What Is This Study About?

This Phase I study will test the safety and tolerability of the investigational drug LY3372993 in healthy adults and older adults with Alzheimer's disease. 

Do I Qualify To Participate in This Study?

Minimum Age: 18 Years

Maximum Age: 85 Years

Must have:

Healthy Participants

  • Overtly healthy as determined by medical history and physical examination
  • Between 18 to 45 years old
  • Males must agree to use a reliable method of birth control during the study and 3 months following the last dose
  • Females not of childbearing potential
  • Body mass index of 18 to 32

Participants with Alzheimer's

  • Mild cognitive impairment due to Alzheimer's disease or or mild to moderate Alzheimer's
  • Positive florbetapir scan on positron emission tomography
  • Men or nonfertile women, at least 55 years of age
  • Have up to two study partners who can provide information about the participant

Must NOT have:

All Participants

  • Significant abnormalities on brain magnetic resonance imaging (MRI)
  • Inability to undergo MRI
  • Significant allergic reactions to LY3372993, or related compounds, or significant allergies to humanized monoclonal antibodies, diphenhydramine, epinephrine, or methylprednisolone
  • Clinically significant neurological or psychological illness, or other illnesses that could affect study results

Healthy Participants

  • Family history of early-onset Alzheimer's disease
  • Impaired cognitive function

Participants with Alzheimer's

  • History of intracranial hemorrhage, cerebrovascular aneurysm or arteriovenous malformation, carotid artery occlusion, or stroke or epilepsy
  • Previously dosed in any other study investigating active immunization against amyloid-beta
  • Previously dosed in any other study investigating passive immunization against amyloid-beta within the last 6 months
  • Current serious or unstable illnesses
 

Study Contact
Eli Lilly and Company
877-285-4559 or 317-615-4559
ClinicalTrials.gov@Lilly.com

Need Help?

Contact NIA’s Alzheimer’s and related Dementias Education and Referral (ADEAR) Center at 800-438-4380 or email ADEAR.

Where Is This Study Located?

California
Collaborative Neuroscience Network - CNS
Long Beach, CA 90806
Florida
Covance Clinical Research Inc
Daytona Beach, FL 32117
Avail Clinical Research LLC
DeLand, FL 32720
MD Clinical
Hallandale Beach, FL 33009
BioClinica Inc
Orlando, FL 32806
IMIC, Inc.
Palmetto Bay, FL 33157
Progressive Medical Research
Port Orange, FL 32127
BioClinica Inc
The Villages, FL 32162
Georgia
Atlanta Center of Medical Research
Atlanta, GA 30331
North Carolina
Carolina Phase 1 Research (Wake M3)
Raleigh, NC 27612
Utah
PRA Health Sciences
Salt Lake City, UT 84124

Who Sponsors This Study?

Lead: Eli Lilly and Company

Source: ClinicalTrials.gov ID: NCT03720548