Clinical Drug Experience Knowledgebase

Criteria

Inclusion Criteria:

Male or female, age 50 yrs or older. Females must be of non-childbearing potential (surgically sterilized or at least 2 yrs post-menopausal)
Must have a cognitive deficit present for at least 1 yr & meet DSM-IV-TRTM criteria for AD & meet NINCDS/ADRDA criteria for the presence of probable AD
Severity of AD must be mild to moderate, documented with a MMSE score of 12-26
Has a CT scan or MRI scan within the prior 12 months, which is compatible with a diagnosis of probable AD
Ability to walk, at least with an assistive device
Vision & hearing sufficient to comply with testing
Normal cognitive & social functioning prior to onset of dementia
Consistent caregiver to accompany patient to assessment visits
Sufficient basic education to be able to complete the cognitive assessments
Living outside an institution
Informed consent signed & dated by patient or legal representative
Has provided written authorization for the use & disclosure of protected health information

Exclusion Criteria:

Dementia due to any condition other than AD, including vascular dementia (modified Hachinski Ischemic Scale ≥ 5; positive NINDS-AIREN criteria)
Evidence of clinically significant unstable cardiovascular, renal, hepatic, gastrointestinal, neurological, or metabolic disease within the past 6 months (as determined by medical history, ECG results, chest x-ray, or physical examination)
Use of any drug within 14 days prior to randomization unless the dose of the drug & the condition being treated have been stable for at least 30 days & are expected to remain stable during the study & neither the drug nor the condition being treated is expected to interfere with the study endpoints
Any medical or psychiatric condition that may require medication or surgical treatment during the study
Life expectancy less than 6 months
Any other screening laboratory values outside the normal ranges that are deemed clinically significant by the investigator
Use of an investigational drug within 30 days prior to the screening visit or during the entire study
Significant neurological disease other than AD, including cerebral tumor, Huntington's Disease, Parkinson's Disease, normal pressure hydrocephalus, & other entities
Major depression according to DSM-IV
Psychotic episodes requiring hospitalization or antipsychotic therapy for more than 2 weeks within the past 10 yrs, not linked to AD
Agitation sufficient to preclude participation in this trial
Alcohol or drug dependence diagnosed within the past 10 yrs
Epilepsy or anti-epileptic drug therapy
Abnormal laboratory tests that might point to another etiology for dementia: serum B12, folate, thyroid functions, electrolytes, syphilis serology
Musculoskeletal diseases that could interfere with assessment
Acute or poorly controlled medical illness: blood pressure> 180 mmHg systolic or 100 mmHg diastolic; myocardial infarction within 6 months; uncompensated congestive heart failure (NYHA Class III or IV), severe renal, hepatic or gastrointestinal disease that could alter drug pharmacokinetics; blood glucose > 180 mg/dl on repeated testing at entry into study or need for insulin therapy
Previous randomization in this trial or participation in another investigational trial < 2 months prior to randomization
Likelihood, according to clinical judgment, of being transferred to a nursing home within 6 months
Change in dosage of any concomitant antidepressant within 30 days prior to randomization
Lack of caregiver
Pregnant or lactating females
Patients who in the judgment of the Investigator may be unreliable or uncooperative with the evaluation procedures outlined in this protocol
HIV positive
Hepatitis B or C positive
Concomitant use of medications other than AD or antidepressant medications for which the dose regimens are stabilized for at least 30 days prior to enrollment in study