Raloxifene for Women With Alzheimer's Disease

Official Title: “Raloxifene in Women With AD: Randomized Controlled Trial”

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

Intervention(s) in this Clinical Trial

• Drug: raloxifene

Primary Measures

• ADAS-cog
  • Time Frame: 12 months
    Safety Issue?: No

Secondary Measures

• Global rating
  • Time Frame: 6 and 12 months
    Safety Issue?: No
• Function
  • Time Frame: 6 and 12 months
    Safety Issue?: No
• Behavior
  • Time Frame: 6 and 12 months
    Safety Issue?: No
• Cognitive (neuropsychological)
  • Time Frame: 6 and 12 months
    Safety Issue?: No

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 MMSE score between 12 and 26, inclusive
• 8. NINCDS-ADRDA criteria for probable 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 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

Gender Eligibility for this Clinical Trial: Female

Minimum Age for this Clinical Trial: N/A

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Investigator: Stanford University Other

Overall Clinical Trial Officials and Contacts

Dr Victor Henderson Principal Investigator Stanford University  

Information obtained from ClinicalTrials.gov on February 12, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00368459

Study ID Number: IA0096

ClinicalTrials.gov Identifier: NCT00368459

Health Authority: United States: Institutional Review Board