Trial Information

Summary: Dainippon Sumitomo Pharma America, Inc. is currently conducting a Phase II clinical trial for Mild to Moderate Alzheimer's Disease.

If you have any patients that you may feel may be a good candidate for the study based on the inclusion/exclusion criteria below, please refer them to our office. Thank you.

Patients may participate in this study if:

• Male or female, = 55 years old
• Diagnosis of Alzheimer's Disease
• Outpatients living with caregivers
• Mild to moderate cognitive impairment with an MMSE score of 12 to 24
• ADAS-Cog score between 14 and 42
• Modified Hachinski Ischemia Scale score =4

Patients may bot participate in this study if

• Neurodegenerative diseases and/or dementias other than AD
• Frequent smoker (more than 10/cigarettes/day) and/or frequent consumer of caffeine (more than 6 cups of tea/coffee or other caffeinated beverages per day).
• Hypothyroidism or folic acid deficiency (< 1.8 ng/mL). Or vitamin B12 deficiency (< 180 pg/mL).
• History or presence of stroke and/or epilepsy
• History of more than 1 myocardial infarction within 5 years before study entry
• Treatment with potential memory/cognitive enhancing drugs within 2 weeks before screening.
• Regular treatment with other psychotropic medication (e.g. antipsychotics, antidepressants, mood stabilizers, anxiolytics, or hypnotics) within 2 weeks before screening (Exception: occasional use of anxiolytic or sedative-hypnotic agents for treatment of agitation and insomnia: stable doses of serotonin and noradrenaline reuptake inhibitors [SNRIs] or selective seratonin reuptake inhibitors [SSRIs], or selective noradrenaline/norepinephrine reuptake inhibitors [NARIs], except fluvoxamine, which were started at least 3 months before randomization).
• Treatment with NMDA receptor antagonist, cholinomimetic drugs, AChEIs, cholinergic agonists, cholinergic precursers loadings such as lecithin, anticholinergic medication or other cholinergic agents within 2 weeks before screening.
• Severe hypotension or hypertension requiring treatment
• Uncontrolled atrial fibrillation and atrioventricular block higher than first degree.
• Treatment with an investigational drug or device within 3 months before screening.

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Trial listings updated: June 1, 2008 at 6:29:51 AM