A Study of LY3002813 in Participants With Alzheimer's Disease

NCT01837641 | Completed Phase 1 Results

• 2 other identifiers: 15082I5T-MC-AACC
• Study Type: interventional
• Target: 63
• Locations: 2 countries
• Sites: 6

Brief Summary

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.

Conditions

Alzheimer Disease

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Pharmacokinetics: Maximum Concentration (Cmax) of LY3002813

  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

  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

Study Arms (9)

LY3002813-Single 0.1 mg/kg then multiple 0.3 mg/kg

EXPERIMENTAL

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

LY3002813-Single then multiple 0.3 mg/kg

EXPERIMENTAL

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

LY3002813-Single 1 mg/kg in Healthy Participants

EXPERIMENTAL

1 mg/kg single dose LY3002813 given once by IV infusion.

Biological: LY3002813-IV

LY3002813-Single then multiple 1 mg/kg

EXPERIMENTAL

1 mg/kg single dose then 1 mg/kg LY3002813 given every 4 weeks for up to 16 weeks IV

Biological: LY3002813-IV

LY3002813-Single then multiple 3 mg/kg

EXPERIMENTAL

3 mg/kg single dose then 3 mg/kg LY3002813 given every 4 weeks for up to 16 weeks IV

Biological: LY3002813-IV

LY3002813-Single then multiple 10 mg/kg

EXPERIMENTAL

10 mg/kg single dose then 10 mg/kg LY3002813 given every 4 weeks for up to 16 weeks IV

Biological: LY3002813-IV

Placebo-Single then multiple

PLACEBO COMPARATOR

Placebo given once, then every 4 weeks for up to 16 weeks IV

Drug: Placebo-IV

LY3002813-SC

EXPERIMENTAL

Up to 3 mg/kg LY3002813 given once subcutaneously (SC)

Biological: LY3002813-SC

LY3002813-IV

EXPERIMENTAL

Up to 3mg/kg LY3002813 given once intravenously (IV)

Biological: LY3002813-IV

Interventions

LY3002813-IV BIOLOGICAL

Administered IV

LY3002813-IV; LY3002813-Single 0.1 mg/kg then multiple 0.3 mg/kg; LY3002813-Single 1 mg/kg in Healthy Participants; LY3002813-Single then multiple 0.3 mg/kg; LY3002813-Single then multiple 1 mg/kg; LY3002813-Single then multiple 10 mg/kg; LY3002813-Single then multiple 3 mg/kg

LY3002813-SC BIOLOGICAL

Administered SC

LY3002813-SC

Placebo-IV DRUG

Administered IV

Placebo-Single then multiple

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Eli Lilly and Company: lead

Study Sites (6)

Collaborative Neuroscience Network - CNS

Long Beach, California, 90806, United States

Location

Compass Research

Orlando, Florida, 32806, United States

Location

Atlanta Center of Medical Research

Atlanta, Georgia, 30308, United States

Location

PRAHealthSciences

Salt Lake City, Utah, 84106, United States

Location

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.

Sumida-Ku, 130-0004, Japan

Location

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, 162-0053, Japan

Location

MeSH Terms

Conditions

Alzheimer Disease

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Results Point of Contact

• Title: Chief Medical Officer
• Organization: Eli Lilly and Company

ClinicalTrials.gov@lilly.com

800-545-5979

Study Officials

• 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 DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 18, 2013
• First Posted: April 23, 2013
• Study Start: May 3, 2013
• Primary Completion: August 24, 2016
• Study Completion: August 24, 2016
• Last Updated: October 4, 2024
• Results First Posted: October 4, 2024

Record last verified: 2024-07

Locations

US (4); JP (2)