Study to Evaluate the Safety, Tolerability and the Effect of BMS-241027 on Cerebrospinal Fluid Biomarkers in Subjects With Mild Alzheimer's Disease
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| ClinicalTrials.gov Identifier: NCT01492374 |
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Recruitment Status :
Completed
First Posted : December 15, 2011
Last Update Posted : July 24, 2014
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Sponsor:
Bristol-Myers Squibb
Information provided by (Responsible Party):
Bristol-Myers Squibb
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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 tests in mild Alzheimer's disease (AD) subjects, following 9 weekly intravenous (IV) infusions of BMS-241027
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Alzheimer's Disease | Drug: BMS-241027 Drug: Placebo matching BMS-241027 | Phase 1 |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 40 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
| Primary Purpose: | Treatment |
| Official Title: | A Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability and the Effect of BMS-241027 on Cerebrospinal Fluid Biomarkers in Subjects With Mild Alzheimer's Disease |
| Study Start Date : | February 2012 |
| Actual Primary Completion Date : | October 2013 |
| Actual Study Completion Date : | October 2013 |
Resource links provided by the National Library of Medicine
MedlinePlus Genetics related topics:
Alzheimer disease
MedlinePlus related topics:
Alzheimer's Disease
| Arm | Intervention/treatment |
|---|---|
| Experimental: Arm 1: BMS-241027 (0.003 mg/kg) |
Drug: BMS-241027
Intravenous (IV), 0.003 mg/kg, Once Weekly, 9 weeks |
| Experimental: Arm 2: BMS-241027 (0.01 mg/kg) |
Drug: BMS-241027
Intravenous (IV), 0.01 mg/kg, Once Weekly, 9 weeks |
| Experimental: Arm 3: BMS-241027 (0.03 mg/kg) |
Drug: BMS-241027
Intravenous (IV), 0.03 mg/kg, Once Weekly, 9 weeks |
| Experimental: Arm 4: Placebo matching BMS-241027 |
Drug: Placebo matching BMS-241027
Intravenous (IV), 0.0 mg/kg, Once Weekly, 9 weeks |
Primary Outcome Measures :
- Safety assessments: based on frequency of Serious Adverse Events (SAEs), frequency of Adverse events (AEs), discontinuation due to AEs and dose reduction [ Time Frame: Within the first 70 day after first dose ]
- Biomarker Measures: CSF levels of Tau N-terminal domain fragments [ Time Frame: Within the first 70 day after first dose ]
Secondary Outcome Measures :
- Effects of BMS-241027 on CSF levels of the mid-domain Tau fragment [ Time Frame: Within the first 70 days after first dose ]
- Effects of BMS-241027 on cognitive performance using computerized cognitive tests [ Time Frame: Weeks 3, 6 and 9 ]
- Effects of BMS-241027 on connectivity MRI [ Time Frame: Within the first 70 days after first dose ]
- Maximal observed plasma concentration (Cmax) of BMS-241027 in subjects with mild Alzheimer's disease [ Time Frame: Weeks 1, 4, and 9 ]Intensive pharmacokinetic parameter Cmax will be derived from subgroups of subjects at Week 7
- Observed plasma concentration at 24 hours post dose (C24) of BMS-241027 in subjects with mild Alzheimer's disease [ Time Frame: Weeks 1, 4, and 9 ]Intensive pharmacokinetic parameter C24 will be derived from subgroups of subjects at Week 7
- Time of maximal observed plasma concentration (Tmax) of BMS-241027 in subjects with mild Alzheimer's disease [ Time Frame: Weeks 1, 4, and 9 ]Intensive pharmacokinetic parameter Tmax will be derived from subgroups of subjects at Week 7
- Area under the concentration-time curve in one dosing interval [AUC(TAU)] of BMS-241027 in subjects with mild Alzheimer's disease [ Time Frame: Weeks 1, 4, and 9 ]Intensive pharmacokinetic parameter AUC(TAU) will be derived from subgroups of subjects at Week 7
- Safety assessments: based on vital sign measurements, ECGs and clinical laboratory tests [ Time Frame: Within the first 70 day after first dose ]
- Effects of BMS-241027 on CSF levels of neurofilaments [ Time Frame: Within the first 70 days after first dose ]
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| Ages Eligible for Study: | 50 Years to 90 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- 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 Criteria:
- 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
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01492374
Locations
Show 24 study locations
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
| Study Director: | Bristol-Myers Squibb | Bristol-Myers Squibb |
Additional Information:
| Responsible Party: | Bristol-Myers Squibb |
| ClinicalTrials.gov Identifier: | NCT01492374 |
| Other Study ID Numbers: |
CN167-003 2011-004065-33 ( EudraCT Number ) |
| First Posted: | December 15, 2011 Key Record Dates |
| Last Update Posted: | July 24, 2014 |
| Last Verified: | October 2013 |
Additional relevant MeSH terms:
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Alzheimer Disease Dementia Brain Diseases Central Nervous System Diseases Nervous System Diseases |
Tauopathies Neurodegenerative Diseases Neurocognitive Disorders Mental Disorders |