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

Completed · Phase 1 · Has a placebo group

Conditions studied: Alzheimer Disease

In brief

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.

Key facts

Study ID: NCT02624778
Run by: Eli Lilly and Company
People needed: 61
Starts: 2015-12-22
Expected to finish: 2019-08-28
Last updated by the study team: 2024-10-08

Who can join

Age: 50 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

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 (Aβ)
Previously dosed in any other study investigating passive immunization against Aβ within the last 6 months
Have current serious or unstable illnesses

Where it is running

Brain Matters Research — Delray Beach, Florida, United States
Compass Research — Orlando, Florida, United States
Compass Research — The Villages, Florida, United States
SNBL Clinical Pharmacology Center Inc — Baltimore, Maryland, United States
St. Louis Clinical Trials, LC — St Louis, Missouri, United States
PRA Health Sciences — Salt Lake City, Utah, United States
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, Japan

Full record on ClinicalTrials.gov

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