Trial record 16 of 339 for:    Open Studies | "Alzheimer Disease"

A Study of LY3002813 in Participants With Alzheimer's Disease

This study is currently recruiting participants.
Verified December 2013 by Eli Lilly and Company
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT01837641
First received: April 18, 2013
Last updated: December 16, 2013
Last verified: December 2013
  Purpose

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

There will be six groups of study participants. Five groups will receive a single dose of LY3002813 or placebo (no drug), followed by up to 4 multiple doses of LY3002813 or placebo given as an injection into a vein. Approximately 12 weeks will pass between the single dose and the first multiple dose. One group of participants will receive a single dose of LY3002813 given as an injection under the skin.


Condition Intervention Phase
Alzheimer Disease
Biological: LY3002813-IV
Biological: LY3002183-SC
Drug: Placebo-IV
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Basic Science
Official Title: A Single-Dose and Multiple-Dose, Dose-Escalation Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of LY3002813 in Patients With Mild Cognitive Impairment Due to Alzheimer's Disease or Mild to Moderate Alzheimer's Disease

Resource links provided by NLM:


Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:
  • Number of Participants With One or More Serious Adverse Events (SAEs) Considered by the Investigator to be Related to Study Drug Administration [ Time Frame: Day 1 up to Day 253 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Pharmacokinetics: Maximum Concentration (Cmax) of LY3002813 [ Time Frame: Predose up to Day 253 ] [ Designated as safety issue: No ]
  • Pharmacokinetics: Area Under the Concentration Curve (AUC) of LY3002813 [ Time Frame: Predose up to Day 253 ] [ Designated as safety issue: No ]

Estimated Enrollment: 100
Study Start Date: May 2013
Estimated Study Completion Date: May 2015
Estimated Primary Completion Date: May 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: LY3002813-Single 0.1 mg/kg then multiple 0.3 mg/kg
0.1 milligram per kilogram (mg/kg) single dose then 0.3 mg/kg LY3002813 given every 4 weeks for up to 16 weeks intravenously (IV)
Biological: LY3002813-IV
Administered IV
Experimental: LY3002813-Single then multiple 0.3 mg/kg
0.3 mg/kg single dose then 0.3 mg/kg LY3002813 given every 4 weeks for up to 16 weeks IV
Biological: LY3002813-IV
Administered IV
Experimental: LY3002813-Single then multiple 1 mg/kg
1 mg/kg single dose then 1 mg/kg LY3002813 given every 4 weeks for up to 16 weeks IV
Biological: LY3002813-IV
Administered IV
Experimental: LY3002813-Single then multiple 3 mg/kg
3 mg/kg single dose then 3 mg/kg LY3002813 given every 4 weeks for up to 16 weeks IV
Biological: LY3002813-IV
Administered IV
Experimental: LY3002813-Single then multiple 10 mg/kg
10 mg/kg single dose then 10 mg/kg LY3002813 given every 4 weeks for up to 16 weeks IV
Biological: LY3002813-IV
Administered IV
Placebo Comparator: Placebo-Single then multiple
Placebo given once, then every 4 weeks for up to 16 weeks IV
Drug: Placebo-IV
Administered IV
Experimental: LY3002813-SC
Up to 3 mg/kg LY3002813 given once subcutaneously (SC)
Biological: LY3002183-SC
Administered SC

  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
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 a caregiver/study informant who provides 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:

  • History of intracranial hemorrhage, cerebrovascular aneurysm or arteriovenous malformation, or carotid artery occlusion, or stroke or epilepsy
  • Do not have a reliable caregiver/study informant who is 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
  • Have any contraindications for magnetic resonance imaging (MRI) studies, including claustrophobia, the presence of contraindicated metal (ferromagnetic) implants, cardiac pacemaker
  • 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
  • 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
  • History within the past 5 years of a primary or recurrent malignant disease with the exception of resected cutaneous squamous cell carcinoma in situ, basal cell carcinoma, cervical carcinoma in situ, or in situ prostate cancer with a normal prostate-specific antigen post resection
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01837641

Contacts
Contact: There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559

Locations
United States, California
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. Recruiting
Long Beach, California, United States, 90806
Contact: Eli Lilly         
United States, Florida
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. Recruiting
Orlando, Florida, United States, 32806
Contact: Eli Lilly         
United States, Georgia
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. Recruiting
Atlanta, Georgia, United States, 30308
Contact: Eli Lilly         
United States, Utah
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. Recruiting
Salt Lake City, Utah, United States, 84106
Contact: Eli Lilly         
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. Recruiting
Sumida-Ku, Japan, 130-0004
Contact: Eli Lilly         
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. Recruiting
Tokyo, Japan, 111-0052
Contact: Eli Lilly         
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
  More Information

No publications provided

Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT01837641     History of Changes
Other Study ID Numbers: 15082, I5T-MC-AACC
Study First Received: April 18, 2013
Last Updated: December 16, 2013
Health Authority: United States: Food and Drug Administration
Japan: Pharmaceuticals and Medical Devices Agency

Additional relevant MeSH terms:
Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders

ClinicalTrials.gov processed this record on April 15, 2014