BMS CN156-018

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 (BMS)

Study was terminated early by BMS in December 2012

This is a phase 2 multi-center, randomized, double-blind, placebo-controlled, 2-arm (BMS-708163125 mg/day versus matching placebo), 24-week treatment period followed by a 28-week follow-up period study for patients with prodromal Alzheimer’s disease (AD) at approximately 60 – 70 study centers in the U.S., Canada, France, Sweden, Finland, Denmark, and Netherlands.

The purpose of this study is to determine the safety, tolerability and potential pharmacodynamic effects of BMS-708163 125 mg/day versus placebo over a 24 week treatment period and a follow-up period of an additional 28 weeks. Secondary objectives are - to characterize the relationship between BMS-708163 exposure and CSFbiomarkers (Aβ40, Aβ42, total Tau, phosphorylated Tau); to assess the predictive value of CSF biomarkers and volumetric MRI with regard to disease progression and potential pharmacodynamic effects during the 6 month treatment period and the 6 month follow-up period; to assess Notch-mediated (safety related) effects of BMS-708163; to assess for drug effects on progression to AD and changes from baseline scores on cognitive and functional scales.

There is a maximum 42 day screening period followed by 24 weeks of treatment and a 28 week follow-up period, during which patients will not be receiving study medication. The estimated enrollment time is 18 months.

Approximately 270 male & female patients between 45 – 90 years of age will be randomized (135 patients per treatment group). MMSE scores will be between 24 - 30 (inclusive), a memory complaint, objective memory loss measured by education adjusted scores on Wechsler Memory Scale Logical Memory II, a CDR Global of 0.5 (memory box must be at least 0.5), absence of significant levels of impairment in other cognitive domains, preserved activities of daily living, and an absence of a clinical diagnosis of dementia. In addition, the study subject’s cerebrospinal fluid (CSF) Aβ42 level must be below 200 pg/mL (consistent with Aβ42 pathology and suggestive of incipient Alzheimer’s disease). In addition, a maximum of 100 subjects who did not meet the CSF inclusion criteria but otherwise fulfilled all other criteria may be eligible to enter a non-randomized observational cohort group. These subjects will be followed, approximately every 3 months, until progression to dementia has occurred. This cohort will not be randomized to study medication but will receive standard of care treatment after diagnosis of dementia is made). The double-blind BMS-708163 or matching placebo capsules will be administered orally once daily (QD). Patients will initially take either 2 capsules (50 mg) a day or matching placebo for the first 2 weeks, and then take five capsules (125 mg) or matching placebo for the remainder of the 24 week treatment period. BMS-708163 will be supplied as 25 mg capsules in bottles.

Last Updated: 02-18-2015
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