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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT01148498
First received: June 18, 2010
Last updated: September 18, 2012
Last verified: August 2012
  Purpose

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.


Condition Intervention Phase
Alzheimer's Disease
Drug: solanezumab
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: Plasma Amyloid Beta Species After a Single Solanezumab Infusion in Nondemented Individuals and Those With Mild Dementia of the Alzheimer's Type

Resource links provided by NLM:


Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 55
Study Start Date: August 2010
Study Completion Date: August 2012
Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Group 1
Older adults with mild Dementia Alzheimer's Type (DAT)
Drug: solanezumab
400mg administered once intravenously
Other Names:
  • LY2062430
  • A Beta Antibody
Experimental: Group 2
Older adult controls with possible Alzheimer's Disease Pathology
Drug: solanezumab
400mg administered once intravenously
Other Names:
  • LY2062430
  • A Beta Antibody
Experimental: Group 3
Older adult controls with no evidence of Alzheimer's Disease
Drug: solanezumab
400mg administered once intravenously
Other Names:
  • LY2062430
  • A Beta Antibody
Experimental: Group 4
Younger subjects who are assumed to have no cognitive impairment
Drug: solanezumab
400mg administered once intravenously
Other Names:
  • LY2062430
  • A Beta Antibody

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01148498

Locations
United States, Missouri
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.
St. Louis, Missouri, United States, 63108
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: NCT01148498     History of Changes
Other Study ID Numbers: 13572, H8A-MC-LZAT
Study First Received: June 18, 2010
Last Updated: September 18, 2012
Health Authority: United States: Food and Drug Administration

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 August 28, 2014