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

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.

Study Type: Interventional

Study Design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study

Study Primary Completion Date: July 2009

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.

Intervention(s) in this Clinical Trial

• Drug: raloxifene
  • two 60 mg tablets daily for 12 months
• Drug: Placebo
  • two placebo tablets daily for 12 months

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1
  • Raloxifene
• Placebo Comparator: 2
  • Placebo

Primary Measures

• Changes in cognitive subscale of the Alzheimer's Disease Assessment Scale
  • Time Frame: at 12 months
    Safety Issue?: No

Secondary Measures

• Changes in Clinical Dementia Rating
  • Time Frame: at 6 and 12 months
    Safety Issue?: No
• Activities of Daily Living (Alzheimer's Disease Cooperative Study scale)
  • Time Frame: at 6 and 12 months
    Safety Issue?: No
• Neuropsychiatric Inventory
  • Time Frame: at 6 and 12 months
    Safety Issue?: No
• Cognitive subscale of the Alzheimer's Disease Assessment Scale
  • Time Frame: at 3, 6, and 9 months
    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
    Safety Issue?: No
• Caregiver burden interview
  • Time Frame: at 6 and 12 months
    Safety Issue?: No

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 Eligibility for this Clinical Trial: Female

Minimum Age for this Clinical Trial: 60 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: National Institute on Aging (NIA)

Overall Clinical Trial Officials and Contacts

Victor Henderson, MD Principal Investigator Stanford University  

Overall Contact: Narinder Bolaria 650-721-3308 nbolaria@stanford.edu

Information obtained from ClinicalTrials.gov on September 05, 2008

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

Study ID Number: IA0096

ClinicalTrials.gov Identifier: NCT00368459

Health Authority: United States: Federal Government