NCT04451408CompletedPhase 1
A Study of LY3372993 in Participants With Alzheimer's Disease (AD) and Healthy Participants
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of LY3372993 in Participants With Alzheimer's Disease and Healthy Participants
Source: ClinicalTrials.gov · Last updated 28 Mar 2025
Brief summary (registry, in English)
The main purpose of this study is to evaluate the safety and tolerability of LY3372993 in participants with AD, non-Japanese, and Japanese healthy participants who are of first-generation Japanese origin. The study will also investigate how much LY3372993 gets into the bloodstream and will test the effects of LY3372993. The study will be conducted in two parts. The part A includes participants with AD and part B includes healthy participants. Participation could last up to about 61 weeks and may include up to 31 visits to the study center.
- Status (registry)
- Completed
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 139 (actual)
- First submitted
- 26 Jun 2020
- Start date
- 7 Jul 2020
- Primary completion date
- 18 Nov 2024
- Lead sponsor
- Eli Lilly and Company
- Diseases
- Alzheimer disease
- NCT number
- NCT04451408
What you commit to
- Study type: Interventional · Phase 1
- Participants enrolled: 139
- From 7 Jul 2020 to the primary completion date, 18 Nov 2024
- 13 sites in 2 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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 a family history of early onset AD (AD diagnosed prior to 65 years of age)
- have used or intend to use over-the-counter or prescription medication including herbal medications within 14 days prior to dosing.
Other illness
- Have history or presence of uncontrolled asthma, significant autoimmune disease, hereditary angioedema, or known history of common variable immune deficiency
- 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 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
- (Part B)
- have a history or presence of significant psychiatric disorders
- have an abnormal blood pressure and/or pulse rate as determined by the investigator, or a pre-existing history of hypertension
Other
- (Part A)
- Contraindication to positron emission tomography (PET)
- any clinically significant ECG or brain MRI abnormalities
Who the study is looking for
- (Part A)
- 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
- (Part B)
- overtly healthy males or females
- have a body mass index of 18.0 to 32.0 kg/m2, inclusive
- To qualify as a participant of the first-generation Japanese origin, the participant, the participant's biological parents, and all of the participant's biological grandparents must be of exclusive Japanese descent and born in Japan.
Age in the registry: 18 years to 85 years · Sex: All · Accepts healthy volunteers
Sites (13)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| The University of Tokyo Hospital Coordinator of this site? Confirm its status | Bunkyō-Ku | Japan | Unknown status |
| Clinical Research Hospital Tokyo Coordinator of this site? Confirm its status | Shinjuku-ku | Japan | Unknown status |
| Oita University Hospital Coordinator of this site? Confirm its status | Yufu | Japan | Unknown status |
| Altasciences Clinical Los Angeles, Inc Coordinator of this site? Confirm its status | Cypress | United States | Unknown status |
| Covance Dallas Coordinator of this site? Confirm its status | Dallas | United States | Unknown status |
| Accel Research Sites- Clinical Research Unit Coordinator of this site? Confirm its status | DeLand | United States | Unknown status |
| MD Clinical Coordinator of this site? Confirm its status | Hallandale | United States | Unknown status |
| Collaborative Neuroscience Research, LLC Coordinator of this site? Confirm its status | Long Beach | United States | Unknown status |
| IMIC, Inc. Coordinator of this site? Confirm its status | Miami | United States | Unknown status |
| Ppd Development Coordinator of this site? Confirm its status | Orlando | United States | Unknown status |
| Progressive Medical Research Coordinator of this site? Confirm its status | Port Orange | United States | Unknown status |
| Charter Research Coordinator of this site? Confirm its status | The Villages | United States | Unknown status |
| Synexus Clinical Research US, Inc. Coordinator of this site? Confirm its status | The Villages | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.