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

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

Recruiting
55-85 years
All
Phase 1

Overview

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.

Eligibility

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

Study details
    Dementia
    Dementia
    Alzheimer's Disease
    Alzheimer's Disease

NCT04451408

Eli Lilly and Company

5 August 2020

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FAQs

Learn more about clinical trials

What is a clinical trial?

A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

Why should I take part in a clinical trial?

Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

How long does a clinical trial take place?

The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

Do I get compensated for taking part in clinical trials?

Compensation varies per trial. Some offer payment or reimbursement for time and travel, while others may not.

How safe are clinical trials?

Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
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