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

Status

Recruiting

Phases

Phase 1

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2080223143

Enrollment

Unknown

Registered

2016-03-11

Start date

2016-03-11

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Alzheimer Disease

Interventions

investigational material(s) Generic name etc : Biological: LY3002813 INN of investigational material : Therapeutic category code : 119 Other agents affecting central nervous system Dosage and Adminis

Eligibility

Sex/Gender

All

Inclusion criteria

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

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

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026