A Study of LY3372993 in Participants With Alzheimer's Disease (AD)

  • STATUS
    Recruiting
  • participants needed
    30
  • sponsor
    Eli Lilly and Company
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Updated on 19 February 2024
See if I qualify
alzheimer's disease
cognitive impairment
mini-mental state examination
dementia
mild cognitive impairment
mental state examination

Summary

The main purpose of this study is to evaluate the safety and tolerability of LY3372993 in participants with AD. The study will also investigate how much LY3372993 gets into the bloodstream and will test the effects of LY3372993. Participation could last up to about 54 weeks and may include up to 22 visits to the study center.

Details
Condition Dementia, Dementia, Alzheimer's Disease, Alzheimer's Disease
Age 55years - 85years
Treatment Placebo, LY3372993
Clinical Study IdentifierNCT04451408
SponsorEli Lilly and Company
Last Modified on19 February 2024

Eligibility

 Yes No Not Sure

Inclusion Criteria

Gradual and progressive changes in memory function reported by participants or their partners for greater than or equal to () 6 months at screening, and a clinical diagnosis of mild cognitive impairment due to AD, or AD dementia, as determined by the investigator or based upon medical history
Mini-Mental State Examination score 16
Have clinical laboratory test results within normal reference range or results with acceptable deviations that are judged to be not clinically significant by the investigator
Have a study partner who will provide written informed consent to participate, is in frequent contact with the participant (defined as at least 10 hours per week), and will accompany the participant to study visits or be available through telephone at designated times

Exclusion Criteria

Have history or presence of uncontrolled asthma, significant autoimmune disease, hereditary angioedema, or known history of common variable immune deficiency
Contraindication to positron emission tomography (PET) scan
Have a history or presence of serious or unstable illnesses including cardiovascular, hepatic, renal, gastrointestinal, respiratory, endocrine, psychiatric, immunologic, or hematologic disease and other conditions that, in the investigator's opinion, could interfere with the analyses in this study, or increase risk for study intervention administration, or result in a participant's life expectancy of less than (<)24 months
Have received treatment with biologic agents (such as monoclonal antibodies, including marketed drugs) within 3 months or 5 half-lives (whichever is longer) prior to dosing
Have had significant medical history of dizziness, syncope, or vasovagal attacks within the past 3 years
Contraindication to magnetic resonance imaging (MRI), including claustrophobia that cannot be managed with low-dose sedatives or the presence of contraindicated metal (ferromagnetic) implants/cardiac pacemaker
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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