Raloxifene for Women With Alzheimer's Disease

Inclusion Criteria:

   1. Female

   2. Post menopausal

   3. Age at least 60 years

   4. Eight or more years of education with a history of premorbid literacy

   5. By history, fluent speaker of English

   6. Dementia (DSM-IV-derived criteria) present for at least six months beginning at age 60
   or older

   7. Mild or moderate dementia, defined by Mini-Mental State examination (MMSE) score
   between 12 and 26, inclusive

   8. National Institute of Neurological and Communicative Disease and the Alzheimer's
   Disease and Related Disorders Association (NINCDS-ADRDA) criteria for probable
   Alzheimer's disease (AD) based on results of a neurologist's evaluation and laboratory
   tests

   9. Neurological history and examination within normal limits for age, except for changes
   consistent with AD or age

10. Modified Ischemia Scale score of 4 or less

11. Good physical health established by medical history, physical exam, and baseline
   laboratory tests

12. Blood pressure < 180/100 at time of entry

13. No history of, or examination evidence for, current insulin-dependent diabetes, stroke
   thought to impair cognition (e.g., cortical or thalamic infarct), or other focal brain
   lesion or neurological disorder likely to affect cognition, or other serious medical
   illness likely to limit participant's ability to complete study protocol

14. No history of pulmonary embolism, deep vein thrombosis, or retinal vein occlusion

15. No Diagnostic and Statistical Manual (DSM) IV criteria for Major Depressive Episode or
   other Axis I psychiatric disorder, other than AD, within the past year

16. Effective dose of an FDA-approved cholinesterase inhibitor for at least 6 months prior
   to randomization (usually donepezil 5 or 10 mg/d, rivastigmine 6 to 12 mg/d, or
   galantamine 16 to 24 mg/d); stable effective dose for at least 2 months prior to
   randomization

17. No psychotropic medication within 4 weeks of study entry or stable dose (for at least
   4 weeks month) of psychotropic medications

18. No experimental mediation for the treatment of cognitive impairment associated with
   dementia within 2 months of study entry

19. No raloxifene within 6 months of study entry

20. No systemic estrogen, progestin, testosterone, related gonadal hormone therapy within
   2 months of study entry

21. No other known contraindication to raloxifene or donepezil

22. A primary caregiver who knows the participant well and who is able to accompany her
   for regular assessments during the course of the study

23. Assent or consent of participant plus informed consent from participant's next of kin
   or legally authorized representative

Exclusion Criteria:

1. Failure to meet inclusion criteria