Raloxifene for Women With Alzheimer's Disease
Condition: Alzheimer Disease
MeSH terms: Alzheimer Disease
Intervention: raloxifene; Placebo
Intervention description: Raloxifene is a selective estrogen receptor modulator; Identical appearing placebo
Intervention MeSH terms: Raloxifene Hydrochloride
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 42.0
Sex: Female
Minimum age: 60 Years
Healthy volunteers: No
Keywords: raloxifene, women

Summary:

      This is a multisite pilot randomized trial of raloxifene or placebo for the treatment of
      women with Alzheimer's disease.
    

Eligibility criteria:

        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