A Study of LY3002813 in Participants With Alzheimer's Disease

Alzheimer Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01837641
• Other study ID #: 15082
• Secondary ID: I5T-MC-AACC
• Status: Completed
• Phase: Phase 1
• First received: April 18, 2013
• Last updated: December 21, 2017
• Start date: May 3, 2013
• Est. completion date: August 24, 2016

Study information

• Verified date: December 2017
• Source: Eli Lilly and Company
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: August 24, 2016
• Est. primary completion date: August 24, 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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 (Aß)

• Previously dosed in any other study investigating passive immunization against Aß within the last 6 months

Related Conditions & MeSH terms

• Alzheimer Disease

Intervention

Biological:
• LY3002813-IV
Administered IV
• LY3002183-SC
Administered SC

Drug:
• Placebo-IV
Administered IV

Locations

Country	Name	City	State
Japan	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
Japan	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
United States	Atlanta Center of Medical Research	Atlanta	Georgia
United States	Collaborative Neuroscience Network - CNS	Long Beach	California
United States	Compass Research	Orlando	Florida
United States	PRAHealthSciences	Salt Lake City	Utah

Sponsors (1)

Lead Sponsor	Collaborator
Eli Lilly and Company

Countries where clinical trial is conducted

United States,  Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With One or More Serious Adverse Events (SAEs) Considered by the Investigator to be Related to Study Drug Administration		Day 1 up to Day 253
Secondary	Pharmacokinetics: Maximum Concentration (Cmax) of LY3002813		Predose up to Day 253
Secondary	Pharmacokinetics: Area Under the Concentration Curve (AUC) of LY3002813		Predose up to Day 253