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A Study of LY3002813 in Participants With Memory Damage Due to Alzheimer's Disease (AD) or AD | Clinical Trials | Clareo Health

COMPLETEDPHASE1

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

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

NCT02624778•Eli Lilly and Company

View on ClinicalTrials.gov

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.

Eligibility

Age

50 - No limit years

Sex

ALL

Healthy Volunteers

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

Locations (9)

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

Sumida-ku, Japan

Key Dates

Start Date

December 22, 2015

Primary Completion Date

August 28, 2019

Completion Date

August 28, 2019

Last Updated

October 8, 2024

Enrollment

ACTUAL participants

Conditions

Alzheimer Disease

Interventions

LY3002813

BIOLOGICAL

Placebo

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: October 8, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

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