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:	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 24-weeks and a follow-up period of 28 weeks.

Condition	Intervention	Phase
Alzheimer's Disease	Drug: BMS-708163 Drug: Placebo	Phase II

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment, Safety Study
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 Dementia

U.S. FDA Resources

Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:

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 ]

Secondary Outcome Measures:

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 ]
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 ]

Estimated Enrollment:	270
Study Start Date:	May 2009
Estimated Study Completion Date:	October 2012
Estimated Primary Completion Date:	October 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
BMS-708163: Experimental	Drug: BMS-708163 Capsules, Oral, 125 mg, once daily, 24 weeks
Placebo: Placebo Comparator	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
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
Women of Child Bearing Potential (WOCBP)
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

Contacts

Contact: For participation information at a USA site use a phone number below. For site information outside the USA please email:		Clinical.Trials@bms.com
Contact: First line of email MUST contain NCT# & Site#. Only trial sites that are recruiting have contact information at this time.

Show 75 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 ( Study Director )
Study ID Numbers:	CN156-018, EUDRACT# : 2009-010067-16
Study First Received:	April 29, 2009
Last Updated:	November 16, 2009
ClinicalTrials.gov Identifier:	NCT00890890 History of Changes
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:

Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Nervous System Diseases
Alzheimer Disease
Central Nervous System Diseases

Neurodegenerative Diseases
Tauopathies
Brain Diseases
Dementia

ClinicalTrials.gov processed this record on November 20, 2009