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Trial record 1 of 3 for:    LY3002813
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A Study of LY3002813 in Participants With Memory Damage Due to Alzheimer's Disease (AD) or AD

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02624778
Recruitment Status : Active, not recruiting
First Posted : December 8, 2015
Last Update Posted : June 25, 2018
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company

Brief 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.


Condition or disease Intervention/treatment Phase
Alzheimer Disease Biological: LY3002813 Drug: Placebo Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Basic Science
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
Study Start Date : December 2015
Estimated Primary Completion Date : September 2019
Estimated Study Completion Date : May 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: LY3002813 Single dose 1
LY3002813 administered intravenously (IV) once
Biological: LY3002813
Administered IV

Experimental: LY3002813 Single dose 2
LY3002813 administered IV once
Biological: LY3002813
Administered IV

Experimental: LY3002813 Single dose 3
LY3002813 administered IV once
Biological: LY3002813
Administered IV

Experimental: LY3002813 Multiple dose 1 x 24 wks
LY3002813 administered IV for 24 wks
Biological: LY3002813
Administered IV

Experimental: LY3002813 Multiple dose 2 x 24 wks
LY3002813 administered IV for 24 weeks
Biological: LY3002813
Administered IV

Experimental: LY3002813 Multiple dose 3 x 72 wks
LY3002813 administered IV for 72 wks
Biological: LY3002813
Administered IV

Experimental: LY3002813 Multiple dose 4 x 72 weeks
LY3002813 administered IV for 72 wks
Biological: LY3002813
Administered IV

Placebo Comparator: Placebo given once
Placebo administered IV once
Drug: Placebo
Administered IV

Placebo Comparator: Placebo x 24 weeks
Placebo administered IV for 24 wks
Drug: Placebo
Administered IV

Placebo Comparator: Placebo x 72 weeks
Placebo administered IV for 72 wks
Drug: Placebo
Administered IV




Primary Outcome Measures :
  1. Florbetapir Positron Emission Tomography (PET) Standardized Uptake Value Ratio (SUVr) [ Time Frame: Predose up to Day 505 ]

Secondary Outcome Measures :
  1. Pharmacokinetics: Serum Concentrations of LY3002813 [ Time Frame: Predose up to Day 589 ]
  2. Change from Baseline in Incidence of Anti-Drug Antibodies [ Time Frame: Predose up to Day 589 ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02624778


Locations
United States, Florida
Brain Matters Research
Delray Beach, Florida, United States, 33445
Compass Research
Orlando, Florida, United States, 32806
Compass Research
The Villages, Florida, United States, 32162
United States, Maryland
SNBL Clinical Pharmacology Center Inc
Baltimore, Maryland, United States, 21201
United States, Missouri
St. Louis Clinical Trials, LC
Saint Louis, Missouri, United States, 63141
United States, Utah
PRA Health Sciences
Salt Lake City, Utah, United States, 84106
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, 162-0053
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, 169-0073
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, 130-0004
Sponsors and Collaborators
Eli Lilly and Company
Investigators
Study Director: 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

Additional Information:
Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT02624778     History of Changes
Other Study ID Numbers: 16233
I5T-MC-AACD ( Other Identifier: Eli Lilly and Company )
First Posted: December 8, 2015    Key Record Dates
Last Update Posted: June 25, 2018
Last Verified: June 2018

Additional relevant MeSH terms:
Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders