Raloxifene for Women With Alzheimer's Disease

• Status: Completed
• Trial end date: 2012-01-01
• Target enrollment: 0
• Participant gender: Female

Summary

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Stanford University
• Collaborators: Indiana University; Kaiser Permanente; Southern Illinois University
• Treatments: Raloxifene Hydrochloride

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