A Single- and Multiple-Dose Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single and Multiple Intravenous Doses of LY3002813

Phase 1

Recruiting

• Conditions: Alzheimer Disease

• Registration Number: JPRN-jRCT2080223143
• Lead Sponsor: Eli Lilly Japan K.K.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-03-11
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Present with mild cognitive impairment (MCI) due to Alzheimer's disease (AD) or mild-to-moderate AD

-Men or nonfertile women, at least 50 years of age. Nonfertile is defined as hysterectomy and/or bilateral oophorectomy, or amenorrhea for at least 1 year

-Have a caregiver/study informant who provides a separate written informed consent to participate

-Have adequate vision and hearing for neuropsychological testing in the opinion of the investigator

-Positive florbetapir scan

Exclusion Criteria

-Do not have a reliable caregiver/study informant who is in frequent contact with the participant, who will accompany the participant to the office and/or be available by telephone at designated times, and will monitor administration of prescribed medications

-Are being monitored for radiation due to occupational exposure to ionized radiation, or exposure to ionizing radiation within last 12 months from an investigational study

-History of intracranial hemorrhage, cerebrovascular aneurysm or arteriovenous malformation, or carotid artery occlusion, or stroke or epilepsy

-Have any contraindications for magnetic resonance imaging (MRI) studies, including claustrophobia, the presence of contraindicated metal (ferromagnetic) implants, cardiac pacemaker

-Have allergies to humanized monoclonal antibodies, including proteins and diphenhydramine, epinephrine, and methylprednisolone

-Have gamma globulin therapy within the last 6 months

-Previously dosed in any other study investigating active immunization against amyloid beta (A beta)

-Previously dosed in any other study investigating passive immunization against A beta

-Have current serious or unstable illnesses

Study & Design

• Study Type: Interventional
• Study Design: Not specified