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
  Purpose

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.


Condition Intervention Phase
Alzheimer's Disease
Drug: Avagacestat
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 263
Study Start Date: May 2009
Study Completion Date: July 2013
Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Avagacestat (50 mg) Drug: Avagacestat
Capsules, Oral, 50 mg, once daily, 104 - 220 Weeks
Other Name: BMS-708163
Placebo Comparator: Placebo Drug: Placebo
Capsules, Oral, 0 mg, once daily, 104 - 220 Weeks

  Eligibility

Ages Eligible for Study:   45 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00890890

  Show 64 Study Locations
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
  More Information

Additional Information:
No publications provided

Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT00890890     History of Changes
Other Study ID Numbers: CN156-018, 2009-010067-16
Study First Received: April 29, 2009
Last Updated: September 4, 2013
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board
Denmark: Danish Medicines Agency
Denmark: Danish Dataprotection Agency
Denmark: The Danish National Committee on Biomedical Research Ethics
Sweden: Medical Products Agency
Sweden: The National Board of Health and Welfare
Sweden: Swedish Data Inspection Board
Sweden: Swedish National Council on Medical Ethics
Finland: Finnish Medicines Agency
Finland: Data Protection Board
Finland: National Advisory Board on Health Care Ethics
Canada: Health Canada
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
France: Institutional Ethical Committee

Additional relevant MeSH terms:
Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders

ClinicalTrials.gov processed this record on April 21, 2014