A Multiple-Dose, Dose-Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of LY3372993 in Participants With Alzheimer’s Disease
Sponsor:
Brief Summary:
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.
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
Locations
- Collaborative Neuroscience Network, Long Beach, California, United States, 90806