Victor W. Henderson
Raloxifene for Women With Alzheimer's Disease
Contact Information
Stanford University School of Medicine 300 Pasteur Drive Stanford, CA 94305Brief
The purpose of this study is to determine whether Raloxifene, a selective estrogen receptor modulator (SERM), improves cognitive function in women with Alzheimer's disease.
Recruiting Status:
RecruitingStanford Recruiting Status:
RecruitingCondition(s):
Intervention(s):
- Drug: raloxifene
Phase:
Phase 2Eligibility
Ages Eligible for Study:
60 years to Any AgeGenders Eligible for Study:
FemaleHealth of Volunteers:
People with the conditions listed in this trial can participate as controls.Key Inclusion Criteria:
- Female, age 60+
- Postmenopausal
- Premorbid literacy and history of having been fluent in English
- Dementia present for at least 6 months beginning at age 60+
- Mild or moderate dementia (Mini-Mental State examination score 12-26, inclusive)
- Probable Alzheimer's disease
- Modified Ischemia Scale score of 4 or less
- Good physical health established by medical history, examination, and baseline laboratory tests
- Effective dose of donepezil, rivastigmine, or galantamine for at least 6 months; stable effective dose for at least 2 months
- Availability of a primary caregiver who knows the participant well and who is able to accompany her for regular assessments during the course of the study
Key Exclusion Criteria:
- Concomitant neurological disorder likely to affect cognition
- Concomitant insulin-dependent diabetes or serious medical illness likely to limit the ability to complete study protocol
- History of pulmonary embolism, deep vein thrombosis, or retinal vein occlusion
- Major depression within past year
- Experimental medication for the treatment of cognitive impairment associated with dementia within 2 months
- Raloxifene within 6 months
- Systemic estrogen, progestin, or testosterone within 2 months
- Known contraindication to raloxifene
Additional Study Details
Official Title:
Raloxifene in Women With AD: Randomized Controlled TrialAnticipated start date:
8/1/2006Lead Sponsor:
National Institute on Aging (NIA)Collaborator(s):
- Indiana University School of Medicine
- Kaiser Permanente
- Stanford University
Investigator(s):
Study Type:
InterventionalPurpose:
TreatmentAllocation:
RandomizedMasking:
Double BlindControl:
noneAssignment:
ParallelEndpoints:
EfficacyPrimary Outcomes:
- Changes in cognitive subscale of the Alzheimer's Disease Assessment Scale, at 12 months
Secondary Outcomes:
- Changes in Clinical Dementia Rating, at 6 and 12 months
- Activities of Daily Living (Alzheimer's Disease Cooperative Study scale), at 6 and 12 months
- Neuropsychiatric Inventory, at 6 and 12 months
- Cognitive subscale of the Alzheimer's Disease Assessment Scale, at 3, 6, and 9 months
- Other cognitive tests (East Boston Memory Test, Digit Ordering, category fluency, Trail Making Test, Boston Naming Test short version, Mini-Mental State examination, narrative writing, semantic binding), at 6 and 12 months
- Caregiver burden interview, at 6 and 12 months
Total Number to be Enrolled:
72Total Number to be Enrolled at Stanford:
0More Information
Publications About this Study:
- 15800139: Yaffe K, Krueger K, Cummings SR, Blackwell T, Henderson VW, Sarkar S, Ensrud K, Grady D. Effect of raloxifene on prevention of dementia and cognitive impairment in older women: the Multiple Outcomes of Raloxifene Evaluation (MORE) randomized trial. Am J Psychiatry. 2005 Apr;162(4):683-90.
Secondary ID(s):
- R01-AG023038
Locations & Contacts
Stanford Locations & Contacts:
Stanford University School of Medicine 300 Pasteur Drive Stanford, CA 94305Non-Stanford Locations:
The Stanford website does not have any locations outside of Stanford listed for this trial. You may want to check clinicaltrials.gov for posible additional locations.
This listing was last updated:
8/26/2009PLEASE NOTE:
Study Coordinators and Research Nurses cannot give medical advice over the phone. Telephone numbers are provided for obtaining additional information on specific clinical research trials only. If you have specific questions which require clinical expertise, please call your primary care physician. If you do not have a primary care physician please feel free to call the SHC Physician Referral Service at (800) 756-9000 or send an email.
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