Double Blind Study of Trp01 in Patients With Alzheimer's Disease

Inclusion Criteria: Patients will be selected in order to fulfill both of the following definitions: * Dementia according to DSM-IV criteria : * development of multiple cognitive deficits manifested by both memory impairment and one or more of the following cognitive disturbances: aphasia, apraxia, agnosia, disturbance in executive functioning * the above-mentioned deficits cause significant impairment in social or occupational functioning * they do not occur exclusively during the course of delirium * Dementia according to communicative disorders and stroke criteria (NINCDS-ADRDA) * dementia established clinically and documented by a Folstein Mini-Mental State Examination (MMSE) * deficits in two or more areas of cognition * progressive worsening of memory and other cognitive functions * no disturbance of consciousness * absence of systematic disorders or other brain diseases that in and of themselves can account for progressive deficit in memory and cognition Furthermore, patients must fulfill the following criteria: * men, or postmenopausal or surgically sterilized women * with severity of dementia of mild to moderate degree as reflected by a score of greater than 14 but less than 26 on the MMSE * with a minimum one-year duration of the symptomatology (progressive worsening of memory and other cognitive functions) * living at home or in an institution provided that they have reliable caregivers * able to perform the required psychometric tests and evaluations. Visual and auditory acuity (with glasses or hearing aid if required) must be sufficient to complete the protocol-specified procedures. * Clinical laboratory battery (see section 7.2.2) must yield results within normal limits or determined as not clinically significant by the study physician for the patient's sex and age * Patients and their substitute decision-makers must have signed the written informed consent form Exclusion Criteria: Patients with any of the following will not be included in the study: * Patients with any other cause of dementia as evidenced by medical history, general physical and neurological examination, laboratory tests, and neuroradiological findings: * Vascular dementia, as evidenced by Modified Hachinski Ischemia Scale * Depressive pseudementia, as evidenced by cognitive disturbances concomitant to a major depressive episode according to DSM-IV and/or a history of more than one major depressive episode * DSM-IV criteria for any major psychiatric disorder including schizophrenia, alcohol or substance abuse * Huntington's chorea or Parkinson's disease, evidenced by neurological examination, with an onset prior to or concurrent with dementia * Creutzfeldt-Jakob disease * Intracranial mass lesion * Clinically important head injury * History or current evidence of stroke * Onset of dementia following cardiac arrest or heart surgery * Neurosyphilis * Seropositivity for HIV * Vitamin B12 deficiency * Uncorrected hypothyroidism (i.e. abnormal free T4, ultrasensitive TSH) * Patients with other relevant concomitant diseases: * Patients with history or current evidence of a sleep disorder * Patients with a clinically significant cardiovascular, renal, hepatic, pulmonary, gastrointestinal, endocrine, metabolic, opthalmologic, or hematologic condition * Current evidence or history within the past year of myocardial infarction (MI), congestive heart failure * Blood pressure at screening of \> 180 mm Hg systolic or 100 mm Hg diastolic * Impaired renal, hepatic, or gastrointestinal function, which could interfere with drug absorption, metabolism or excretion * Seizure disorder * Diabetes * Earlier diagnosis or current evidence of cataracts * Progressive fatal disease (other than AD) * Treatment with any other investigational drug in the last 8 weeks prior to screening * Previous administration of TRP01