Study to Evaluate the Safety, Tolerability and the Effect of BMS-241027 on Cerebrospinal Fluid Biomarkers in Subjects With Mild Alzheimer's Disease
Study to Evaluate the Safety, Tolerability and the Effect of BMS-241027 on Cerebrospinal Fluid Biomarkers in Subjects With Mild Alzheimer's Disease
The purpose of the study is to evaluate safety and the pharmacodynamic effects of BMS-241027
 on cerebrospinal fluid (CSF) Tau, connectivity magnetic resonance imaging (MRI), and
 computerized cognitive tests in mild Alzheimer's disease (AD) subjects, following 9 weekly
 intravenous (IV) infusions of BMS-241027
Inclusion Criteria:

 -  Mild AD Subjects meeting National Institute of Neurological Disorders and Stroke -
 Alzheimer's Disease Related Disorders Association(NINCDS-ADRDA) and Diagnostic and
 Statistical Manual of Mental Disorders-Forth Edition, Text Revision (DSM-IV-TR)
 criteria

 -  Mini-Mental State Exam (MMSE) Score between 20 & 26 (inclusive)

 -  CSF consistent with AD pathology

 -  Screening brain MRI - normal - commensurate with age or demonstrate atrophy consistent
 with AD diagnosis (dx); reveal no more than mild white matter disease; up to 2 lacunar
 infarcts acceptable except in anterior thalamus, genu of internal capsule or basal
 forebrain; reveal no cortical infarcts; reveal no more than 4 microbleeds; reveal no
 focal asymmetric lobar atrophy or other findings suggesting primary cause of dementia
 is attributed to a cause other than AD; reveal no macrohemorrhages (>10 mm)

 -  Subjects must have reliable study partners

 -  Men and Women of Non Child Bearing Potentia (WONCBP), ages 50-90 years

 Exclusion Criteria:

 -  Subjects with any other medical condition other than mild AD that could explain
 subjects' memory or cognitive deficits

 -  Subjects diagnosed with moderate or severe AD per DSM-IV criteria

 -  Subjects with a history (hx) of stroke

 -  Subjects with a hx of GI illnesses

 -  Subjects with Vitamin B12 or folate deficiency

 -  Subjects with any unstable cardiovascular (CV), pulmonary, Gastrointestinal (GI) or
 hepatic disease within 30 days prior to screening

 -  Subjects with active liver dx or history of hepatic intolerance

 -  Subjects with a Geriatric Depression Scale score of ≥ 6 at screening

 -  Subjects treated for or have had a diagnosis of schizophrenia

 -  Subjects treated for or have had a diagnosis of bipolar disease within 3 years prior
 to screening

 -  Subjects with a history of generalized peripheral neuropathy