Start:
November 5, 2018
End:
May 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?
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
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?
Source:
ClinicalTrials.gov ID:
NCT03720548