A Study of LY3002813 in Participants With Alzheimer's Disease

A Single-Dose and Multiple-Dose, Dose-Escalation Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of LY3002813 in Patients With Mild Cognitive Impairment Due to Alzheimer's Disease or Mild to Moderate Alzheimer's Disease

The study will evaluate the safety of LY3002813 by looking at adverse events. The study will also look at the effect the body has on LY3002813. Study participants will be healthy or will have mild cognitive impairment (MCI) due to Alzheimer's disease (AD) or mild to moderate AD.

There will be seven groups of study participants. Five groups will receive a single dose of LY3002813 or placebo (no drug), followed by up to 4 multiple doses of LY3002813 or placebo given as an injection into a vein. Approximately 12 weeks will pass between the single dose and the first multiple dose. One group of participants will receive a single dose of LY3002813 given as an injection under the skin. One group of participants will receive a single dose of LY3002813 given as an injection into a vein.

Study Overview

• Status: Completed
• Conditions: Alzheimer Disease
• Intervention / Treatment: Biological: LY3002813-IV; Drug: Placebo-IV; Biological: LY3002813-SC

• Study Type: Interventional
• Enrollment (Actual): 63
• Phase: Phase 1

Contacts and Locations

Study Locations

• Japan
  • Sumida-Ku, Japan, 130-0004
    • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
  • Tokyo, Japan, 162-0053
    • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
• United States
  • California
    • Long Beach, California, United States, 90806
      • Collaborative Neuroscience Network - CNS
  • Florida
    • Orlando, Florida, United States, 32806
      • Compass Research
  • Georgia
    • Atlanta, Georgia, United States, 30308
      • Atlanta Center of Medical Research
  • Utah
    • Salt Lake City, Utah, United States, 84106
      • PRAHealthSciences

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Healthy Participants:

  • Overtly healthy males, as determined by medical history and physical examination, willing to use a reliable method of birth control and will not donate sperm during the study
  • Between 18 to 40 years old.
  • Body Mass Index (BMI) of between 18.0 and 30.0 kilogram per meter square (kg/m^2), inclusive

• Participants with Mild Cognitive Impairment Due to Alzheimer's Disease (AD) or AD:

  • Present with mild cognitive impairment (MCI) due to 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:

-Healthy Participants: Have a history or presence of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, immunological, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs; of constituting a risk when taking the study medication; or of interfering with the interpretation of data

• Participants with Mild Cognitive Impairment Due to AD or AD:

  • 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 within the past 5 years of a primary or recurrent malignant disease with the exception of resected cutaneous squamous cell carcinoma in situ, basal cell carcinoma, cervical carcinoma in situ, or in situ prostate cancer with a normal prostate-specific antigen post resection

• All Participants:

  • 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 year
  • Previously dosed in any other study investigating active immunization against amyloid beta (Aβ)
  • Previously dosed in any other study investigating passive immunization against Aβ within the last 6 months

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

9

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: LY3002813-Single 0.1 mg/kg then multiple 0.3 mg/kg; 0.1 milligram per kilogram (mg/kg) single dose then 0.3 mg/kg LY3002813 given every 4 weeks for up to 16 weeks intravenously (IV)	Biological: LY3002813-IV; Administered IV
Experimental: LY3002813-Single then multiple 0.3 mg/kg; 0.3 mg/kg single dose then 0.3 mg/kg LY3002813 given every 4 weeks for up to 16 weeks IV	Biological: LY3002813-IV; Administered IV
Experimental: LY3002813-Single then multiple 1 mg/kg; 1 mg/kg single dose then 1 mg/kg LY3002813 given every 4 weeks for up to 16 weeks IV	Biological: LY3002813-IV; Administered IV
Experimental: LY3002813-Single then multiple 3 mg/kg; 3 mg/kg single dose then 3 mg/kg LY3002813 given every 4 weeks for up to 16 weeks IV	Biological: LY3002813-IV; Administered IV
Experimental: LY3002813-Single then multiple 10 mg/kg; 10 mg/kg single dose then 10 mg/kg LY3002813 given every 4 weeks for up to 16 weeks IV	Biological: LY3002813-IV; Administered IV
Placebo Comparator: Placebo-Single then multiple; Placebo given once, then every 4 weeks for up to 16 weeks IV	Drug: Placebo-IV; Administered IV
Experimental: LY3002813-SC; Up to 3 mg/kg LY3002813 given once subcutaneously (SC)	Biological: LY3002813-SC; Administered SC
Experimental: LY3002813-IV; Up to 3mg/kg LY3002813 given once intravenously (IV)	Biological: LY3002813-IV; Administered IV
Experimental: LY3002813-Single 1 mg/kg in Healthy Participants; 1 mg/kg single dose LY3002813 given once by IV infusion.	Biological: LY3002813-IV; Administered IV

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With One or More Serious Adverse Events (SAEs) Considered by the Investigator to be Related to Study Drug Administration	Data presented are the number of participants who experienced SAEs which were considered to be related to study treatment by the investigator while on treatment and during the follow-up. Summaries of SAEs and other non-serious adverse events (AEs), regardless of causality, are located in the Reported Adverse Events module.	Day 1 up to Day 253

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pharmacokinetics: Maximum Concentration (Cmax) of LY3002813	Maximum Concentration (Cmax) of LY3002813 after the first dose was evaluated.	Pre-dose, end of infusion for IV or 1h post injection for SC, 3, 24, 72, 96(SC), 120(SC), 144(SC), 168, 336, 504, 672, 1008, 1344, 1680 and 2016 hours (h) post-dose
Pharmacokinetics: Area Under the Concentration Versus Time Curve From Time Zero to Infinity [AUC(0-∞)] of LY3002813	Area Under the Concentration Versus Time Curve From Time Zero to Infinity [AUC(0-∞)] of LY3002813 after the first dose was evaluated.	Pre-dose, end of infusion for IV or 1h post injection for SC, 3, 24, 72, 96(SC), 120(SC), 144(SC), 168, 336, 504, 672, 1008, 1344, 1680 and 2016h post-dose

Collaborators and Investigators

• Sponsor: Eli Lilly and Company
• Investigators: Study Director: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST), Eli Lilly and Company

Study record dates

Study Major Dates

• Study Start (Actual): May 3, 2013
• Primary Completion (Actual): August 24, 2016
• Study Completion (Actual): August 24, 2016

Study Registration Dates

• First Submitted: April 18, 2013
• First Submitted That Met QC Criteria: April 18, 2013
• First Posted (Estimated): April 23, 2013

Study Record Updates

• Last Update Posted (Actual): October 4, 2024
• Last Update Submitted That Met QC Criteria: July 8, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Neurodegenerative Diseases; Dementia; Tauopathies; Alzheimer Disease
• Other Study ID Numbers: 15082; I5T-MC-AACC (Other Identifier: Eli Lilly and Company)