| 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 Cerebrospinal fluid (CSF) and amyloid imaging (11-C Pittsburgh compound-B [PIB])
findings consistent with underlying AD pathology, defined as CSF Aβ1-42 less than or
equal to 500 pg/ml, and prominent PIB binding in prefrontal cortex, precuneus, and
temporal cortex, with little binding in cerebellar cortex and brainstem with a mean
cortical binding potential (MCBP) of >0.18
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 CSF Aβ1-42 less than or equal to 500 pg/ml and positive PIB
binding (MCBP >0.18)
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 CSF Aβ1-42 >500 pg/ml and no significant cortical PIB binding
(MCBP less than or equal to 0.18)
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- Have previously completed or withdrawn from this study or any other study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 |
| Study is available at: |
|
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, MO 63108
United States
Primary Contact:
This is a single-site clinical trial. 1-877-CTLILLY (1-877-285-4559) or
Phone: 1-317-615-4559 |