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A Biomarker Study of Solanezumab in Patients With and Without Alzheimer's

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ClinicalTrials.gov Identifier: NCT01148498
Recruitment Status : Completed
First Posted : June 22, 2010
Last Update Posted : September 25, 2012
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company

Tracking Information
First Submitted Date  ICMJE June 18, 2010
First Posted Date  ICMJE June 22, 2010
Last Update Posted Date September 25, 2012
Study Start Date  ICMJE August 2010
Actual Primary Completion Date August 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 18, 2010)
Mean change from baseline up to 112 days post drug administration in plasma levels of Aβ fragment-2 in (Group 1) and (Group 3) [ Time Frame: Baseline up to 112 days post drug administration ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 18, 2010)
  • Mean change in plasma levels of Aβ1-42 after solanezumab infusion [ Time Frame: Baseline (pre-dose); 30 minutes; 24 hours; 7, 28, 56 and 112 days post-dose ]
  • Mean change in plasma levels of Aβ1-40 species after solanezumab infusion [ Time Frame: Baseline (pre-dose); 30 minutes; 24 hours; 7, 28, 56 and 112 days post-dose ]
  • Mean change in plasma levels of modified Aβ species after solanezumab infusion [ Time Frame: Baseline (pre-dose); 30 minutes; 24 hours; 7, 28, 56 and 112 days post-dose ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Biomarker Study of Solanezumab in Patients With and Without Alzheimer's
Official Title  ICMJE Plasma Amyloid Beta Species After a Single Solanezumab Infusion in Nondemented Individuals and Those With Mild Dementia of the Alzheimer's Type
Brief Summary The purpose of this trial is to compare the average change in the amount of amyloid beta species in blood after an infusion of solanezumab.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Condition  ICMJE Alzheimer's Disease
Intervention  ICMJE Drug: solanezumab
400mg administered once intravenously
Other Names:
  • LY2062430
  • A Beta Antibody
Study Arms  ICMJE
  • Experimental: Group 1
    Older adults with mild Dementia Alzheimer's Type (DAT)
    Intervention: Drug: solanezumab
  • Experimental: Group 2
    Older adult controls with possible Alzheimer's Disease Pathology
    Intervention: Drug: solanezumab
  • Experimental: Group 3
    Older adult controls with no evidence of Alzheimer's Disease
    Intervention: Drug: solanezumab
  • Experimental: Group 4
    Younger subjects who are assumed to have no cognitive impairment
    Intervention: Drug: solanezumab
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Estimated Enrollment  ICMJE
 (submitted: June 18, 2010)
55
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE August 2012
Actual Primary Completion Date August 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

Individuals in Groups 1, 2, and 3, described below, will be participants in the longitudinal studies of memory and aging at the Washington University Alzheimer's Disease Research Center (WU-ADRC). These participants must have results from apolipoprotein E (ApoE) genotyping from the WU-ADRC. At the beginning of the study they must be between 45 and 90 years of age and if a female of childbearing potential, not be breastfeeding, test negative for pregnancy, and be using a medically accepted form of birth control at the time of the infusion and for 6 months afterward. Subjects must also meet the criteria below for each study group

Group 1, Mild dementia of Alzheimer's type (DAT):

  • Have mild DAT, as determined by Clinical Dementia Rating (CDR) of 0.5 or 1
  • Have florbetapir PET imaging findings consistent with underlying AD pathology.

Group 2, Older Adult Controls with Possible AD Pathology:

Have no cognitive impairment as indicated by a CDR rating of 0. Have possible AD pathology, as determined by florbetapir PET imaging.

Group 3, Older Adult Controls with No Evidence of AD Pathology:

Have no cognitive impairment as indicated by a CDR rating of 0. Have no evidence of AD pathology as determined by florbetapir PET imaging.

Individuals recruited into Group 4 will not be participants in the longitudinal studies of memory and aging at WU-ADRC. To be included in Group 4, individuals must meet these criteria:

  • Are at least 18 years and <35 years of age at the beginning of the study and if a female of childbearing potential, is not breastfeeding, tests negative for pregnancy and is using highly effective contraception at the time of the solanezumab infusion and for 6 months following infusion
  • Have a Folstein Mini-Mental State Examination (MMSE) score of 29 to 30 at the beginning of the study

Exclusion Criteria:

  • Have previously completed or withdrawn from this study or any other study investigating solanezumab
  • Does not have good venous access, such that intravenous drug delivery or multiple blood draws would be precluded
  • Has allergies to humanized monoclonal antibodies
  • Has a known history of human immunodeficiency virus (HIV), clinically significant multiple or severe drug allergies, or severe posttreatment hypersensitivity reactions (including, but not limited to, erythema multiforme major, linear IgA dermatosis, toxic epidermal necrolysis, or exfoliative dermatitis)
  • Has a history of chronic alcohol or drug abuse/dependence
  • Is clinically judged by the investigator to be at serious risk for suicide
  • Has a recent (within 6 months before screening) or current laboratory result (if available) indicating a clinically significant laboratory abnormality
  • Has Electrocardiogram (ECG) abnormalities obtained at screening that, in the opinion of the investigator, are clinically significant with regard to the subject's participation in the study. Bazett's corrected QT [QTcB] interval must be evaluated and must not exceed >458 msec in males or >474 msec in females
  • At screening, has alanine transaminase (ALT/SGPT) values greater than or equal to 2 times the upper limit of normal (ULN) of the performing laboratory, aspartate transaminase (AST/SGOT) values greater than or equal to 3 times the ULN, or total bilirubin values greater than or equal to 2 times the ULN
  • Has had IgG therapy (sometimes called gamma globulin therapy) within the last year or previous participation in any other study investigating active immunization against Aβ
  • Requires treatment with other monoclonal antibodies
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 90 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01148498
Other Study ID Numbers  ICMJE 13572
H8A-MC-LZAT ( Other Identifier: Eli Lilly and Company )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Eli Lilly and Company
Study Sponsor  ICMJE Eli Lilly and Company
Collaborators  ICMJE Not Provided
Investigators  ICMJE
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
PRS Account Eli Lilly and Company
Verification Date August 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP