BMS CN156-018

Short Study Name (acronym):BMS CN156-018

Long Name:A Multicenter, Randomized Double-Blind Placebo-Controlled Study of the safety, Tolerability, Pharmacodynamic and Pharmacokinetic Effects of BMS-708163 in the Treatment of Patients with Prodromal Alzheimer's Disease

Investigators (list PI first):
Franklin Watkins, MD
Jeff Williamson, MD

Funding Agency:
Bristol Myers Squibb

Funding Dates:
2/2010 – 6/2013

Research questions or aims:
To assess the safety and tolerability of BMS-708163 in patients with prodromal Alzheimer’s disease and to assess the predictive value of cerebral spinal fluid (CSF) biomarkers (A
β40, and Aβ42, total Tau, phosphorylated Tau) on progression to dementia.

Target population:
Male and female outpatients, 45 - 90 years of age who meet Prodromal Alzheimer’s Disease criteria, are medically stable and have a reliable study partner.

Target # to enroll:
10

Target Dates of enrollment:
May 29, 2009 – September 2010 (tentative)

Types of assessments and questionnaires:
Medical History, Dementia History, Demographics, Modified Hachinski Ischemia Scale,  Geriatric Depression Scale, Physical Examination, Neurological Examination, Vital Signs, ECG, Concomitant Medications, MMSE, CDR–SB (Clinical Dementia Rating Sum of Boxes), Neuropsychiatric Inventory Questionnaire, ADAS-COG(Alzheimer's Disease Assessment Scale-cognitive subscale, Executive Function Tests, ADCS-ADL/MCI, Wechsler Logical Memory Subscale, Free & Cued Selective Recall Reminding Test, MoCA (Montreal Cognitive Assessment) and Sheehan Suicidality Tracking Scale

Other data collected:
Screening Safety Laboratory Tests, Pharmacokinetic Sampling, Lumbar Puncture - CSF Biomarkers, CSF Pharmacokinetic Sampling, Genetic testing, Plasma and mRNA testing, Volumetric and Safety Head MRI and Safety Head MRI

Study Website (if applicable):www.memorylossclinicaltrials.com

Coordinator Contact Info:
Leslie Gordineer  

Email: lgordine@wakehealth.edu
Phone: 336-713-8477

 

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