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Multiple Dose Japanese Bridging Study

2014-08-27 03:16:21 | BioPortfolio

Summary

The purpose of this study is to assess the safety and tolerability of multiple oral daily doses of BMS-708163 in healthy young male subjects

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)

Conditions

Alzheimer Disease

Intervention

BMS-708163, Placebo

Location

California Clinical Trials Medical Group
Glendale
California
United States
91206

Status

Active, not recruiting

Source

Bristol-Myers Squibb

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:16:21-0400

Clinical Trials [1014 Associated Clinical Trials listed on BioPortfolio]

A Phase II, Multicenter, Double Blind, Placebo-Controlled Safety, Tolerability Study of BMS-708163 in Patients With Mild to Moderate Alzheimer's Disease

The purpose of this study is to determine the safety and tolerability of BMS-708163 in patients with mild to moderate Alzheimer's disease over a treatment period of 12-weeks and the course...

Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of BMS-708163

The purpose of the study is to evaluate the pharmacokinetics, safety and tolerability of BMS-708163 administered as single and multiple doses in Chinese subjects

Drug Interaction Study With a Potential Alzheimer's Disease Compound

The purpose of this study is to determine whether BMS-708163 will effect the pharmacokinetics of the commonly prescribed medicines midazolam, warfarin, caffeine,omeprazole and dextromethor...

Effect on the Electrocardiographic QT Interval Corrected for Heart Rate (QTc) in Healthy Subjects

The purpose of this study is to determine the effect of BMS-708163 on the QTc interval (QT interval corrected for heart rate).

Drug-Drug Interaction Study With Aricept® (Donepezil)

The purpose of this study is to find out if the plasma concentration of donepezil is changed when BMS-708163 is administered at the same time

PubMed Articles [15642 Associated PubMed Articles listed on BioPortfolio]

Placebo Effects in the Treatment of Noncognitive Symptoms of Alzheimer's Disease: Analysis of the CATIE-AD Data.

To compare symptom trajectories between placebo and active drug responders and to examine whether early placebo improvement would be associated with subsequent placebo response in the treatment of pat...

Imaging correlations of tau, amyloid, metabolism, and atrophy in typical and atypical Alzheimer's disease.

Neuroimaging modalities can measure different aspects of the disease process in Alzheimer's disease, although the relationship between these modalities is unclear.

Cerebrospinal Fluid C-C Motif Chemokine Ligand 2 Correlates with Brain Atrophy and Cognitive Impairment in Alzheimer's Disease.

Chronic neuroinflammation has been implicated in Alzheimer's disease (AD) pathology.

Disentangling the biological pathways involved in early features of Alzheimer's disease in the Rotterdam Study.

Exploring the role of Alzheimer's disease (AD) implicated pathways in the predementia phase may provide new insight for preventive and clinical trials targeting disease specific pathways.

Cortical microstructural changes along the Alzheimer's disease continuum.

Cortical mean diffusivity (MD) and free water (FW) changes are proposed biomarkers for Alzheimer's disease (AD).

Medical and Biotech [MESH] Definitions

Abnormal structures located chiefly in distal dendrites and, along with NEUROFIBRILLARY TANGLES and SENILE PLAQUES, constitute the three morphological hallmarks of ALZHEIMER DISEASE. Neuropil threads are made up of straight and paired helical filaments which consist of abnormally phosphorylated microtubule-associated tau proteins. It has been suggested that the threads have a major role in the cognitive impairment seen in Alzheimer disease.

Vaccines or candidate vaccines used to prevent or treat ALZHEIMER DISEASE.

A progressive form of dementia characterized by the global loss of language abilities and initial preservation of other cognitive functions. Fluent and nonfluent subtypes have been described. Eventually a pattern of global cognitive dysfunction, similar to ALZHEIMER DISEASE, emerges. Pathologically, there are no Alzheimer or PICK DISEASE like changes, however, spongiform changes of cortical layers II and III are present in the TEMPORAL LOBE and FRONTAL LOBE. (From Brain 1998 Jan;121(Pt 1):115-26)

A carbamate-derived reversible CHOLINESTERASE INHIBITOR that is selective for the CENTRAL NERVOUS SYSTEM and is used for the treatment of DEMENTIA in ALZHEIMER DISEASE and PARKINSON DISEASE.

A biochemical phenomenon in which misfolded proteins aggregate either intra- or extracellularly. Triggered by factors such as MUTATION, POST-TRANSLATIONAL MODIFICATIONS, and environmental stress, it is generally associated with ALZHEIMER DISEASE; PARKINSON DISEASE; HUNTINGTON DISEASE; and TYPE 2 DIABETES MELLITUS.

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