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A Multicenter, Double Blind, Placebo-Controlled, Safety and Tolerability Study of BMS-708163 in Patients With Prodromal Alzheimer's Disease

This study has been terminated.
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT00890890
First received: April 29, 2009
Last updated: September 4, 2013
Last verified: September 2013

April 29, 2009
September 4, 2013
May 2009
July 2013   (final data collection date for primary outcome measure)
  • 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 ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]
Adverse Events [ Time Frame: During the treatment phase, every 2 weeks for the first 8 weeks, then monthly for the next 16weeks. Then every 8-weeks during the follow-up period (Weeks 28, 36, & 52) ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT00890890 on ClinicalTrials.gov Archive Site
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 ] [ Designated as safety issue: No ]
  • To assess the predictive value and longitudinal behavior of CSF biomarkers (Aβ40,Aβ42, total Tau, phosphorylated Tau) and volumetric MRI [ Time Frame: Biomarkers will be assessed at Baseline, Week 24 and Week 52 ] [ Designated as safety issue: No ]
  • Prospectively characterize effects on the following assessments as part of the natural course (in placebo patients) & potential impact of BMS-708163. Assess drug effects on progression to dementia (based on confirmed progression using DSM-IV criteria) [ Time Frame: Progression to dementia will be assessed on an ongoing basis at all scheduled visits ] [ Designated as safety issue: No ]
  • Global clinical impression as assessed with the Clinical Dementia Rating-Sum of Boxes (CDR-SB), an instrument designed to measure the severity of cognitive symptoms in daily life [ Time Frame: CDR-SB will be assessed at baseline, week 12, week 24, week 36 & week 52 ] [ Designated as safety issue: No ]
  • To assess Notch-mediated (safety related) effects of BMS-708163 [ Time Frame: Notch-mediated safety assessments will be done at every visit ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
 
A Multicenter, Double Blind, Placebo-Controlled, Safety and Tolerability Study of BMS-708163 in Patients With Prodromal Alzheimer's Disease
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

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.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Alzheimer's Disease
  • Drug: Avagacestat
    Capsules, Oral, 50 mg, once daily, 104 - 220 Weeks
    Other Name: BMS-708163
  • Drug: Placebo
    Capsules, Oral, 0 mg, once daily, 104 - 220 Weeks
  • Experimental: Avagacestat (50 mg)
    Intervention: Drug: Avagacestat
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
263
July 2013
July 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Patient meets clinical criteria for prodromal Alzheimer's disease (MMSE 24-30)
  • Memory complaint by subject or study partner
  • CSF aβ42 levels < 200pg/mL or Total Tau/aβ42 ratio of ≥ 0.39
  • Score of ≤4 on the Modified Hachinski Ischemia Scale
  • CT results consistent with Alzheimer's disease
  • Medically stable
  • 6 years education
  • Reliable study partner
  • Must be able to swallow capsules

Exclusion Criteria:

  • Premenopausal women
  • DSM-IV diagnosis of Dementia History of stroke
  • Immunocompromised
  • Active peptic ulcer, GI bleed, chronic inflammatory bowel disease, chronic diarrhea or past GI surgery that would impact drug absorption
  • Unstable Vitamin B-12 deficiency
  • Hematologic or solid malignancy within 5 years
  • Geriatric Depression Scale ≥ 6
  • Unstable medical condition
  • Alcohol or drug abuse history with 12-months of study entry
  • Significant drug allergy
  • Prisoners, compulsory psychiatric patients, or residents of nursing home or skilled nursing facility at entry
  • Any other experimental therapy with 30-days of study entry
Both
45 Years to 90 Years
No
Contact information is only displayed when the study is recruiting subjects
United States,   Canada,   Denmark,   Finland,   France,   Sweden
 
NCT00890890
CN156-018, 2009-010067-16
Yes
Bristol-Myers Squibb
Bristol-Myers Squibb
Not Provided
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
Bristol-Myers Squibb
September 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP