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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
40
Intravenous (IV), 0.003 mg/kg, Once Weekly, 9 weeks
Intravenous (IV), 0.01 mg/kg, Once Weekly, 9 weeks
Intravenous (IV), 0.03 mg/kg, Once Weekly, 9 weeks
Anaheim Clinical Trials Llc
Anaheim, California, United States
Safety assessments: based on frequency of Serious Adverse Events (SAEs), frequency of Adverse events (AEs), discontinuation due to AEs and dose reduction
Time frame: Within the first 70 day after first dose
Biomarker Measures: CSF levels of Tau N-terminal domain fragments
Time frame: Within the first 70 day after first dose
Effects of BMS-241027 on CSF levels of the mid-domain Tau fragment
Time frame: Within the first 70 days after first dose
Effects of BMS-241027 on cognitive performance using computerized cognitive tests
Time frame: Weeks 3, 6 and 9
Effects of BMS-241027 on connectivity MRI
Time frame: Within the first 70 days after first dose
Maximal observed plasma concentration (Cmax) of BMS-241027 in subjects with mild Alzheimer's disease
Intensive pharmacokinetic parameter Cmax will be derived from subgroups of subjects at Week 7
Time frame: Weeks 1, 4, and 9
Observed plasma concentration at 24 hours post dose (C24) of BMS-241027 in subjects with mild Alzheimer's disease
Intensive pharmacokinetic parameter C24 will be derived from subgroups of subjects at Week 7
Time frame: Weeks 1, 4, and 9
Time of maximal observed plasma concentration (Tmax) of BMS-241027 in subjects with mild Alzheimer's disease
Intensive pharmacokinetic parameter Tmax will be derived from subgroups of subjects at Week 7
Time frame: Weeks 1, 4, and 9
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Intravenous (IV), 0.0 mg/kg, Once Weekly, 9 weeks
Unnamed facility
Long Beach, California, United States
Ucsf Memory And Aging Center
San Francisco, California, United States
Alpine Clinical Research Center, Inc.
Boulder, Colorado, United States
Associated Neurologists Of Southern Connecticut, P.C.
Fairfield, Connecticut, United States
Compass Research, Llc
Orlando, Florida, United States
Palm Beach Neurological Center Advanced Research Consultants
Palm Beach Gardens, Florida, United States
Alexian Brothers Neurosciences Institute Clinical Research
Elk Grove Village, Illinois, United States
Brigham And Women'S Hospital
Boston, Massachusetts, United States
Michigan State University
East Lansing, Michigan, United States
...and 14 more locations
Area under the concentration-time curve in one dosing interval [AUC(TAU)] of BMS-241027 in subjects with mild Alzheimer's disease
Intensive pharmacokinetic parameter AUC(TAU) will be derived from subgroups of subjects at Week 7
Time frame: Weeks 1, 4, and 9
Safety assessments: based on vital sign measurements, ECGs and clinical laboratory tests
Time frame: Within the first 70 day after first dose
Effects of BMS-241027 on CSF levels of neurofilaments
Time frame: Within the first 70 days after first dose