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Raloxifene for Women With Alzheimer's Disease

This study is currently recruiting participants.
Information provided by National Institute on Aging (NIA)

This Tabular View shows the required WHO registration data elements as marked by †

Descriptive Information Fields
Brief Title † Raloxifene for Women With Alzheimer's Disease
Official Title † Raloxifene in Women With AD: Randomized Controlled Trial
Brief Summary

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.
Detailed Description

Alzheimer's disease is the most common cause of dementia, and effective treatment options remain quite limited. Raloxifene, a selective estrogen receptor modulator (SERM), is approved at lower doses for treatment and prevention of osteoporosis in postmenopausal women. Its clinical profile is well known. In laboratory studies, this compound affects brain activity in ways that might be expected to improve cognitive function, and recent clinical data support the hypothesis that a higher dose of raloxifene could improve dementia symptoms in women with Alzheimer's disease.

This is a randomized, double-blind, placebo-controlled trial of raloxifene for the treatment of women with this disorder. Eligible women must have been on a stable effective dose of a cholinesterase inhibitor for at least six months prior to randomization. An estimated 72 women with mild to moderate dementia due to Alzheimer's disease will be enrolled at two sites in this pilot study, and treatment duration will be for 12 months.
Study Phase Phase II
Study Type † Interventional
Study Design † Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study
Primary Outcome Measure † Changes in cognitive subscale of the Alzheimer's Disease Assessment Scale [ Time Frame: at 12 months ] [ Designated as safety issue: No ]
Secondary Outcome Measure † Changes in Clinical Dementia Rating [ Time Frame: at 6 and 12 months ] [ Designated as safety issue: No ]
Activities of Daily Living (Alzheimer's Disease Cooperative Study scale) [ Time Frame: at 6 and 12 months ] [ Designated as safety issue: No ]
Neuropsychiatric Inventory [ Time Frame: at 6 and 12 months ] [ Designated as safety issue: No ]
Cognitive subscale of the Alzheimer's Disease Assessment Scale [ Time Frame: at 3, 6, and 9 months ] [ Designated as safety issue: No ]
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) [ Time Frame: at 6 and 12 months ] [ Designated as safety issue: No ]
Caregiver burden interview [ Time Frame: at 6 and 12 months ] [ Designated as safety issue: No ]
Condition † Alzheimer's Disease
Intervention † Drug: raloxifene
Drug: Placebo
MEDLINE PMIDs 15800139
Links
Recruitment Information Fields
Recruitment Status † Recruiting
Enrollment † 72
Start Date † August 2006
Completion Date July 2009
Eligibility Criteria †

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

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
Gender Female
Ages 60 Years and older
Accepts Healthy Volunteers No
Contacts ††
Contact: Narinder Bolaria     650-721-3308     nbolaria@stanford.edu    
Location Countries † United States
Administrative Information Fields
NCT ID † NCT00368459
Organization ID IA0096
Secondary IDs †† R01-AG023038
Study Sponsor † National Institute on Aging (NIA)
Collaborators †† Indiana University
Kaiser Permanente
Stanford University
Southern Illinois University
Investigators †
Principal Investigator:     Victor Henderson, MD     Stanford University    
Information Provided By National Institute on Aging (NIA)
Verification Date February 2008
First Received Date † August 22, 2006
Last Updated Date February 11, 2008

 †    Required WHO trial registration data element.
††   WHO trial registration data element that is required only if it exists.

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