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

NCT01148498 | Completed Phase 2

• 2 other identifiers: 13572H8A-MC-LZAT
• Study Type: interventional
• Target: 55
• Locations: 1 country
• Sites: 1

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.

Conditions

Alzheimer's Disease

Outcome Measures

Primary Outcomes (1)

• Mean change from baseline up to 112 days post drug administration in plasma levels of Aβ fragment-2 in (Group 1) and (Group 3)

  Baseline up to 112 days post drug administration

Secondary Outcomes (3)

• Mean change in plasma levels of Aβ1-42 after solanezumab infusion

  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

  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

  Baseline (pre-dose); 30 minutes; 24 hours; 7, 28, 56 and 112 days post-dose

Study Arms (4)

Group 1

EXPERIMENTAL

Older adults with mild Dementia Alzheimer's Type (DAT)

Drug: solanezumab

Group 2

EXPERIMENTAL

Older adult controls with possible Alzheimer's Disease Pathology

Drug: solanezumab

Group 3

EXPERIMENTAL

Older adult controls with no evidence of Alzheimer's Disease

Drug: solanezumab

Group 4

EXPERIMENTAL

Younger subjects who are assumed to have no cognitive impairment

Drug: solanezumab

Interventions

solanezumab DRUG

400mg administered once intravenously

Also known as: LY2062430, A Beta Antibody

Group 1; Group 2; Group 3; Group 4

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Eli Lilly and Company: lead

Study Sites (1)

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, 63108, United States

Location

MeSH Terms

Conditions

Alzheimer Disease

Interventions

solanezumab

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Study Officials

• 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

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 18, 2010
• First Posted: June 22, 2010
• Study Start: August 1, 2010
• Primary Completion: August 1, 2012
• Study Completion: August 1, 2012
• Last Updated: September 25, 2012

Record last verified: 2012-08

Locations

US (1)