A Study of LY3303560 in Participants With Mild Cognitive Impairment or Alzheimer's Disease (NCT03019536) | Clinical Trial Compass
CompletedPhase 1
A Study of LY3303560 in Participants With Mild Cognitive Impairment or Alzheimer's Disease
United States22 participantsStarted 2017-01-31
Plain-language summary
The study involves repeated doses of LY3303560 given by infusion for 49 weeks. The study will examine how safe repeated doses of LY3303560 are, whether they cause side effects in participants with mild cognitive impairment or Alzheimer's Disease, and how LY3303560 is handled by the body and acts in the body. This study will last up to 65 weeks, not including screening. Screening is required within 90 days prior to the start of the study.
Who can participate
Age range50 Years
SexALL
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Inclusion Criteria:
* Mild Cognitive Impairment (MCI) due to Alzheimer's Disease (AD) or mild-to-moderate AD based on National Institute of Aging and Alzheimer's Association diagnostic criteria
* Female participants: women not of child-bearing potential may participate, and include those who are:
* Infertile due to surgical sterilisation (hysterectomy, bilateral oophorectomy, or for countries outside of Japan, tubal ligation), congenital anomaly such as mullerian agenesis; or
* Postmenopausal defined as women at least 50 years of age with an intact uterus who have not taken hormones or oral contraceptives within 1 year, who have had either cessation of menses for at least 1 year, or 6 to 12 months of spontaneous amenorrhea with follicle-stimulating greater than (\>) 40 milli-international units per millilitre (mIU/mL)
* Have a body weight of at least 50 kilogram (kg) (except for Japanese sites) and have a body mass index (BMI) of 18.0 to 35.0 kilogram per meter square (kg/m²) (for all sites), inclusive, at screening
Exclusion Criteria:
* Are currently enrolled in a clinical trial involving an investigational product (IP) or any other type of medical research judged not to be scientifically or medically compatible with this study
* Have participated, within the last 30 days (3 months and 4 months for sites in the European Union \[EU\] and Japan, respectively) in a clinical trial involving an IP. If the previous IP has a long half-life, 3 months (4 months for sites in J…
What they're measuring
1
Number of Participants With One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration