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Trial record 2 of 3 for:    LY3303560

A Study of LY3303560 in Participants With Mild Cognitive Impairment or Alzheimer's Disease

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: NCT03019536
Recruitment Status : Active, not recruiting
First Posted : January 12, 2017
Last Update Posted : October 2, 2018
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company

Brief Summary:
The study involves repeated doses of LY3303560 given by injection for 25 weeks. The study will examine how safe repeated doses of LY3303560 are, whether they cause side effects in participants with mild cognitive impairment or Alzheimer's Disease, and how LY3303560 is handled by the body and acts in the body. This study will last up to 64 weeks, not including screening. Screening is required within 90 days prior to the start of the study.

Condition or disease Intervention/treatment Phase
Alzheimer Disease Drug: LY3303560 - IV Drug: Placebo - IV Drug: Florbetapir F 18 Drug: Flortaucipir F18 Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Official Title: Multiple-Dose, Dose-Escalation Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of LY3303560 in Patients With Mild Cognitive Impairment Due to Alzheimer's Disease or Mild to Moderate Alzheimer's Disease
Actual Study Start Date : January 31, 2017
Estimated Primary Completion Date : June 4, 2019
Estimated Study Completion Date : June 5, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: LY3303560 IV
Multiple doses of LY3303560 administered intravenously (IV) for up to 48 weeks, followed by a 16 week follow-up period
Drug: LY3303560 - IV
Administered IV

Drug: Florbetapir F 18
Administered IV during the Positron Emission Tomography (PET) scan performed during screening.
Other Names:
  • Florbetaben F 18
  • Flutemetamol F 18

Drug: Flortaucipir F18
Administered IV during the PET scan performed during the study.
Other Names:
  • AV-1451
  • [F-18]T807
  • LY3191748

Experimental: Placebo IV
Multiple doses of placebo administered IV for up to 48 weeks, followed by a 16 week follow-up period
Drug: Placebo - IV
Administered IV

Drug: Florbetapir F 18
Administered IV during the Positron Emission Tomography (PET) scan performed during screening.
Other Names:
  • Florbetaben F 18
  • Flutemetamol F 18

Drug: Flortaucipir F18
Administered IV during the PET scan performed during the study.
Other Names:
  • AV-1451
  • [F-18]T807
  • LY3191748




Primary Outcome Measures :
  1. Number of Participants with One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration [ Time Frame: Baseline up to 16 weeks ]

Secondary Outcome Measures :
  1. Pharmacokinetics: Maximum Serum Concentration (Cmax) of LY3303560 [ Time Frame: Post first dose through 64 weeks ]
  2. Pharmacokinetics: Area Under the Serum Concentration Time Curve During the Dosing Interval (AUC) of LY3303560 [ Time Frame: Post first dose through 64 weeks ]


Information from the National Library of Medicine

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

Inclusion Criteria:

  • Mild Cognitive Impairment (MCI) due to Alzheimer's Disease (AD) or mild-to-moderate AD based on National Institute of Aging and Alzheimer's Association diagnostic criteria
  • Female participants: women not of child-bearing potential may participate, and include those who are:

    • Infertile due to surgical sterilisation (hysterectomy, bilateral oophorectomy, or for countries outside of Japan, tubal ligation), congenital anomaly such as mullerian agenesis; or
    • Postmenopausal defined as women at least 50 years of age with an intact uterus who have not taken hormones or oral contraceptives within 1 year, who have had either cessation of menses for at least 1 year, or 6 to 12 months of spontaneous amenorrhea with follicle-stimulating greater than (>) 40 milli-international units per millilitre (mIU/mL)
  • Have a body weight of at least 50 kilogram (kg) (except for Japanese sites) and have a body mass index (BMI) of 18.0 to 35.0 kilogram per meter square (kg/m²) (for all sites), inclusive, at screening

Exclusion Criteria:

  • Are currently enrolled in a clinical trial involving an investigational product (IP) or any other type of medical research judged not to be scientifically or medically compatible with this study
  • Have participated, within the last 30 days (3 months and 4 months for sites in the European Union [EU] and Japan, respectively) in a clinical trial involving an IP. If the previous IP has a long half-life, 3 months (4 months for sites in Japan) or 5 half-lives (whichever is longer) should have passed
  • Have known allergies to LY3303560, related compounds or any components of the formulation, or history of significant atopy
  • Have significant allergies to humanised monoclonal antibodies, diphenhydramine, adrenaline, or methylprednisolone; or have a history of clinically significant multiple or severe drug allergies, or intolerance to topical corticosteroids, or severe post treatment hypersensitivity reactions (including, but not limited to, erythema multiforme major, linear immunoglobulin A dermatosis, toxic epidermal necrolysis, or exfoliative dermatitis)
  • Have an increased risk of seizures as evidenced by a history of head trauma with loss of consciousness within the last 5 years or any seizure; prior electroencephalogram with epileptiform activity; surgery to the cerebral cortex; or history within the last 5 years of a serious infectious disease affecting the brain
  • Have any contraindications for Magnetic Resonance Imaging (MRI) studies, including claustrophobia, or the presence of metal (ferromagnetic) implants or a cardiac pacemaker
  • Have a history of intracranial haemorrhage, cerebrovascular aneurysm, or arteriovenous malformation, carotid artery occlusion, or epilepsy
  • Have received acetylcholinesterase inhibitors (AChEIs), memantine, and/or other AD therapy for less than 4 weeks, or have less than 4 weeks of stable therapy on these treatments by time of randomisation (including less than 4 weeks since stopping AChEIs and/or memantine); or have received medications that affect the central nervous system, except treatments for AD, for less than 4 weeks at a stable dose
  • Have used stable medical therapy for less than 2 months by time of randomization for any concurrent medical condition that is not exclusionary
  • Are currently using or intend to use drugs known to significantly prolong the QT interval, or who have a known risk factor for Torsades de Pointes. A participant will not be excluded if they have been using stable medication that is known to potentially cause significant prolongation of the QT interval, but does not present with any clinically significant prolongation of the QT interval at screening, in the opinion of the investigator
  • History of cancer within the last 5 years, with the exception of non-metastatic basal and/or squamous cell carcinoma of the skin, in situ cervical cancer, non-progressive prostate cancer, or other cancers with low risk of recurrence or spread.

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): NCT03019536


Locations
United States, Florida
Bioclinica
Melbourne, Florida, United States, 32940
Bioclinica
Orlando, Florida, United States, 32806
Progressive Medical Research
Port Orange, Florida, United States, 32127
Bioclinica
The Villages, Florida, United States, 32162
United States, New Jersey
Princeton Medical Institute
Princeton, New Jersey, United States, 08540
Japan
For additional information regarding investigative sites for this trial, contact 1-888-545-5972 Mon - Fri, 9 AM to 4 PM or 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri, 9 AM to 5 PM Eastern Time or speak with your personal physician.
Bunkyo-ku, Japan, 113-8655
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.
Hyogo, Japan, 650-0047
For additional information regarding investigative sites for this trial, contact 1-888-545-5972 Mon - Fri, 9 AM to 4 PM or 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri, 9 AM to 5 PM Eastern Time or speak with your personal physician.
Kurume, Japan, 830-0011
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, Japan, 192-0071
United Kingdom
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.
Bath, United Kingdom, BA1 3NG
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.
London, United Kingdom, W6 8RF
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: NCT03019536     History of Changes
Other Study ID Numbers: 16452
I8G-MC-LMDD ( Other Identifier: Eli Lilly and Company )
2016-002102-39 ( EudraCT Number )
First Posted: January 12, 2017    Key Record Dates
Last Update Posted: October 2, 2018
Last Verified: October 1, 2018

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

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