A Study of LY3002813 in Participants With Memory Damage Due to Alzheimer's Disease (AD) or AD

Alzheimer Disease Clinical Trial

Official title:

A Single- and Multiple-Dose Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single and Multiple Intravenous Doses 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: NCT02624778
• Other study ID #: 16233
• Secondary ID: I5T-MC-AACD
• Status: Completed
• Phase: Phase 1
• Start date: December 22, 2015
• Est. completion date: August 28, 2019

Study information

• Verified date: June 2020
• Source: Eli Lilly and Company
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The study will evaluate the effect of LY3002813 on brain scans. The study will evaluate the safety of LY3002813 by looking at adverse events (side effects). The study will also look at the effect the body has on LY3002813. Study participants will have mild cognitive impairment (MCI) due to AD or mild to moderate AD.

The study involves 3 parts.

• Part A in which participants will receive a single dose of LY3002813 or placebo (no drug).

• Part B in which participants will receive multiple doses of LY3002813 or placebo for 24 weeks.

• Part C in which participants will receive multiple doses of LY3002813 or placebo for up to 72 weeks.

Drug will be given as an intravenous infusion (injection into a vein). For Parts A, B and C, the study will last approximately 72 weeks, not including screening of approximately 56 days. The study is for research purposes only and is not intended to treat any medical condition.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 61
• Est. completion date: August 28, 2019
• Est. primary completion date: August 28, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

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 up to 2 partners who will provide 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 up to 2 reliable partners who are 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 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

• Have current serious or unstable illnesses

Related Conditions & MeSH terms

• Alzheimer Disease

Intervention

Biological:
• LY3002813
Administered IV

Drug:
• Placebo
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.	Shinjuku-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, 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST) or speak with your personal physician.	Shinjuku-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, 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST) or speak with your personal physician.	Sumida-ku
United States	SNBL Clinical Pharmacology Center Inc	Baltimore	Maryland
United States	Brain Matters Research	Delray Beach	Florida
United States	Compass Research	Orlando	Florida
United States	St. Louis Clinical Trials, LC	Saint Louis	Missouri
United States	PRA Health Sciences	Salt Lake City	Utah
United States	Compass Research	The Villages	Florida

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	Florbetapir Positron Emission Tomography (PET) Standardized Uptake Value Ratio (SUVr)		Predose up to Day 505
Secondary	Pharmacokinetics: Serum Concentrations of LY3002813		Predose up to Day 589
Secondary	Change from Baseline in Incidence of Anti-Drug Antibodies		Predose up to Day 589

External Links

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