Raloxifene for Women With Alzheimer's Disease

Trial ID or NCT#

NCT00368459

Status

not recruiting iconNOT RECRUITING

Purpose

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

Official Title

Raloxifene in Women With AD: Randomized Controlled Trial

Eligibility Criteria

Ages Eligible for Study: Older than 60 Years
Sexes Eligible for Study: FEMALE
Accepts Healthy Volunteers: No
Inclusion Criteria:
  1. 1. Female2. Post menopausal3. Age at least 60 years4. Eight or more years of education with a history of premorbid literacy5. By history, fluent speaker of English6. Dementia (DSM-IV-derived criteria) present for at least six months beginning at age 60 or older7. Mild or moderate dementia, defined by Mini-Mental State examination (MMSE) score between 12 and 26, inclusive8. 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 tests9. Neurological history and examination within normal limits for age, except for changes consistent with AD or age10. Modified Ischemia Scale score of 4 or less11. Good physical health established by medical history, physical exam, and baseline laboratory tests12. Blood pressure \< 180/100 at time of entry13. 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 protocol14. No history of pulmonary embolism, deep vein thrombosis, or retinal vein occlusion15. No Diagnostic and Statistical Manual (DSM) IV criteria for Major Depressive Episode or other Axis I psychiatric disorder, other than AD, within the past year16. 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 randomization17. No psychotropic medication within 4 weeks of study entry or stable dose (for at least 4 weeks month) of psychotropic medications18. No experimental mediation for the treatment of cognitive impairment associated with dementia within 2 months of study entry19. No raloxifene within 6 months of study entry20. No systemic estrogen, progestin, testosterone, related gonadal hormone therapy within 2 months of study entry21. No other known contraindication to raloxifene or donepezil22. A primary caregiver who knows the participant well and who is able to accompany her for regular assessments during the course of the study23. Assent or consent of participant plus informed consent from participant's next of kin or legally authorized representative
Exclusion Criteria:
  1. 1. Failure to meet inclusion criteria
View All Criteria
Show Less

Investigator(s)

Victor W. Henderson, MD, MS
Victor W. Henderson, MD, MS
Memory disorders specialist
Professor of Epidemiology and Population Health and of Neurology

Contact us to find out if this trial is right for you.

Contact

Narinder Bolaria
6507313308

View on ClinicalTrials.gov