At a glance
ClinicalIndex Comparison Record- ✓Diagnosis of Mild Cognitive Impairment (MCI) due to Alzheimer's Disease or mild-to-moderate Alzheimer's Disease based on NIA-AA diagnostic criteria
- ✓Female participants must be post-menopausal or surgically sterile
- ✓Body weight at least 50 kg (except Japanese sites) and BMI 18.0-35.0 kg/m²
- ✕Currently enrolled in or participated within 30 days (3-4 months at EU/Japan sites) in a clinical trial with an investigational product
- ✕Known allergy to LY3303560, related compounds, or significant allergies to humanized monoclonal antibodies, diphenhydramine, adrenaline, or methylprednisolone
- ✕Increased seizure risk: history of head trauma with loss of consciousness within 5 years, any seizure, prior EEG with epileptiform activity, cerebral cortex surgery, or serious brain infection within 5 years
- ✕Contraindications to MRI including claustrophobia, ferromagnetic implants, or cardiac pacemaker
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Multiple-Dose, Dose-Escalation Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of LY3303560 in Patients With Mild Cognitive Impairment Due to Alzheimer's Disease or Mild to Moderate Alzheimer's Disease
In Brief
A Phase 1 clinical trial evaluating LY3303560 - IV, Placebo - IV, and 2 other interventions for Alzheimer Disease. Completed, enrolled 22 participants across 11 sites in 3 countries.
Detailed 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.
Study Details
Timeline
Interventions
Administered IV
Administered IV
Administered IV during the Positron Emission Tomography (PET) scan performed during screening.
Administered IV during the PET scan performed during the study.