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

Sponsor:	Bristol-Myers Squibb
Information provided by (Responsible Party):	Bristol-Myers Squibb
ClinicalTrials.gov Identifier:	NCT00890890

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: BMS-708163 Drug: Placebo	Phase II

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:

Genetics Home Reference related topics: Alzheimer disease

MedlinePlus related topics: Alzheimer's Disease

U.S. FDA Resources

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 MRI findings [ Time Frame: During the treatment phase, every 2 weeks for the first 8 weeks, then monthly for the next 16 weeks and then every 12 weeks for the remainder of the study. In addition patients will be seen for safety visits at 4 and 12 weeks post treatment ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

To assess the predictive value of CSF biomarkers (Aβ40, and Aβ42, total Tau, phosphorylated Tau) on progression to dementia [ Time Frame: Biomarkers will be assessed at Baseline, Week 2 (optional) Week 24 and Week 104. Progression to dementia will be assessed on an ongoing basis at all scheduled visits. ] [ Designated as safety issue: No ]

Estimated Enrollment:	270
Study Start Date:	May 2009
Estimated Study Completion Date:	November 2013
Estimated Primary Completion Date:	November 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: BMS-708163	Drug: BMS-708163 Capsules, Oral, 50 mg, once daily, 24 weeks
Placebo Comparator: Placebo	Drug: Placebo Capsules, Oral, 0 mg, once daily, 24 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 72 Study Locations

Sponsors and Collaborators

Bristol-Myers Squibb

Investigators

Study Director:

Bristol-Myers Squibb

More Information

Additional Information:

BMS Clinical Trials Disclosure This link exits the ClinicalTrials.gov site

Investigator Inquiry form This link exits the ClinicalTrials.gov site

For FDA Safety Alerts and Recalls refer to the following link: http://www.fda.gov/MEDWATCH/safety.htm This link exits the ClinicalTrials.gov site

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:	February 2, 2012
Health Authority:	United States: Food and Drug Administration; Denmark: Danish Medicines Agency; Sweden: Medical Products Agency; Finland: Finnish Medicines Agency; Canada: Health Canada; France: Afssaps - French Health Products Safety Agency; France: Institutional Ethical Committee; Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

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 February 07, 2012