A Phase 2 interventional study of Avagacestat and Placebo in Alzheimer's Disease, sponsored by Bristol-Myers Squibb. Terminated at 64 sites in 6 countries. Open to participants aged 45 Years to 90 Years. Per ClinicalTrials.gov, last updated 2015-10-12.
Sponsored by Bristol-Myers Squibb · Phase 2, Interventional, and Treatment
The purpose of this study is to determine the safety and tolerability of BMS-708163 in patients with Prodromal Alzheimer's disease over a treatment period of a minimum of 104-weeks. In addition patients will be seen for safety visits at 4 and 12 weeks post treatment.
3,678 studies on the registry are indexed under Alzheimer Disease; 872 are open to participants now.
This study's enrollment of 263 is above the median of 70 across 2,808 interventional studies indexed under Alzheimer Disease.
Browse Alzheimer Disease studies →Bristol-Myers Squibb is the lead sponsor of 1,538 studies on the registry; 116 are open to participants now.
Of its 429 completed or terminated interventional studies of FDA-regulated products, 223 (52%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Drug: Avagacestat
Drug: Placebo
Capsules, Oral, 50 mg, once daily, 104 - 220 Weeks
Also known as: BMS-708163
Capsules, Oral, 0 mg, once daily, 104 - 220 Weeks
Safety and tolerability of BMS-708163 in patients with Prodromal Alzheimer's disease as measured by adverse events, vital signs, laboratory assessments, electrocardiograms (ECGs) and Safety Head Magnetic resonance imaging (MRI) findings
Time frame: Every 12 weeks up to week 220
Safety and tolerability of BMS-708163 in patients with Prodromal Alzheimer's disease as measured by adverse events, vital signs, laboratory assessments, electrocardiograms (ECGs) and Safety Head Magnetic resonance imaging (MRI) findings
Time frame: Avagacestat-treated patients will be seen for safety visits at 4 Post Treatment/Study Termination
Safety and tolerability of BMS-708163 in patients with Prodromal Alzheimer's disease as measured by adverse events, vital signs, laboratory assessments, electrocardiograms (ECGs) and Safety Head Magnetic resonance imaging (MRI) findings
Time frame: Avagacestat-treated patients will be seen for safety visits at 12 Post Treatment/Study Termination
Safety and tolerability of BMS-708163 in patients with Prodromal Alzheimer's disease as measured by adverse events, vital signs, laboratory assessments, electrocardiograms (ECGs) and Safety Head Magnetic resonance imaging (MRI) findings
Time frame: Avagacestat-treated patients will have a 24 week post treatment skin examination by a dermatologist
Predictive value of Cerebral Spinal Fluid (CSF) biomarkers (Aβ40, and Aβ42, total Tau, total Tau/Aβ42 ratio, phosphorylated Tau) on progression to dementia
Time frame: Baseline (Week 0), Week 2 (optional), Week 24 and Week 104
This study is terminated, as verified in Sep 2015. You cannot join it, but the record below documents what was studied.
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