Status:
COMPLETED
Study to Evaluate the Safety, Tolerability and the Effect of BMS-241027 on Cerebrospinal Fluid Biomarkers in Subjects With Mild Alzheimer's Disease
Lead Sponsor:
Bristol-Myers Squibb
Conditions:
Alzheimer's Disease
Eligibility:
All Genders
50-90 years
Phase:
PHASE1
Brief Summary
The purpose of the study is to evaluate safety and the pharmacodynamic effects of BMS-241027 on cerebrospinal fluid (CSF) Tau, connectivity magnetic resonance imaging (MRI), and computerized cognitive...
Eligibility Criteria
Inclusion
- Mild AD Subjects meeting National Institute of Neurological Disorders and Stroke - Alzheimer's Disease Related Disorders Association(NINCDS-ADRDA) and Diagnostic and Statistical Manual of Mental Disorders-Forth Edition, Text Revision (DSM-IV-TR) criteria
- Mini-Mental State Exam (MMSE) Score between 20 \& 26 (inclusive)
- CSF consistent with AD pathology
- Screening brain MRI - normal - commensurate with age or demonstrate atrophy consistent with AD diagnosis (dx); reveal no more than mild white matter disease; up to 2 lacunar infarcts acceptable except in anterior thalamus, genu of internal capsule or basal forebrain; reveal no cortical infarcts; reveal no more than 4 microbleeds; reveal no focal asymmetric lobar atrophy or other findings suggesting primary cause of dementia is attributed to a cause other than AD; reveal no macrohemorrhages (\>10 mm)
- Subjects must have reliable study partners
- Men and Women of Non Child Bearing Potentia (WONCBP), ages 50-90 years
Exclusion
- Subjects with any other medical condition other than mild AD that could explain subjects' memory or cognitive deficits
- Subjects diagnosed with moderate or severe AD per DSM-IV criteria
- Subjects with a history (hx) of stroke
- Subjects with a hx of GI illnesses
- Subjects with Vitamin B12 or folate deficiency
- Subjects with any unstable cardiovascular (CV), pulmonary, Gastrointestinal (GI) or hepatic disease within 30 days prior to screening
- Subjects with active liver dx or history of hepatic intolerance
- Subjects with a Geriatric Depression Scale score of ≥ 6 at screening
- Subjects treated for or have had a diagnosis of schizophrenia
- Subjects treated for or have had a diagnosis of bipolar disease within 3 years prior to screening
- Subjects with a history of generalized peripheral neuropathy
Key Trial Info
Start Date :
February 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2013
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT01492374
Start Date
February 1 2012
End Date
October 1 2013
Last Update
July 24 2014
Active Locations (24)
Enter a location and click search to find clinical trials sorted by distance.
1
Anaheim Clinical Trials Llc
Anaheim, California, United States, 92801
2
Long Beach, California, United States, 90806
3
Ucsf Memory And Aging Center
San Francisco, California, United States, 94158
4
Alpine Clinical Research Center, Inc.
Boulder, Colorado, United States, 80304