Study to Evaluate the Safety, Tolerability and the Effect of BMS-241027 on Cerebrospinal Fluid Biomarkers in Subjects With Mild Alzheimer's Disease

• Status: Completed
• Trial end date: 2013-10-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Bristol-Myers Squibb

Criteria

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