Clinical trial NCT00065767: Cognitive and Neurophysiological Effects of Raloxifene in Alzheimer's Disease
Official title: Cognitive and Neurophysiological Effects of Raloxifene in Alzheimer's Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Alzheimer Disease
Keywords: Alzheimer disease
Postmenopausal women
Hormone therapy
Lead sponsor: University of Wisconsin, Madison
Sponsor class: OTHER
Collaborators: name: National Institute on Aging (NIA)
First posted: 2003-08-04
Enrollment: 20
Sex: FEMALE
Minimum age (years): 55
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study is to determine the effectiveness of treatment with raloxifene, an estrogen-like medication approved by the Food and Drug Administration for the treatment of osteoporosis, in improving memory and the ability to live independently in postmenopausal women with Alzheimer's disease.

Detailed description: The aim of this study is to determine the effectiveness of treatment with raloxifene, an estrogen-like medication (classified as Selective Estrogen Receptor Modulators (SER's)) approved by the Food and Drug Administration for the treatment of osteoporosis, in improving memory and the ability to live independently in postmenopausal women with Alzheimer's disease. Patients who volunteer for this study will need to visit the clinic 7 times (participate) over a period of five months and will receive either raloxifene or a harmless, inactive pill called a placebo. Neither the volunteers nor the study staff will know which type of pill a patient receives. Patients must be generally healthy and have mild-to-moderate dementia. There must be a patient caregiver who can watch for side effects and ensure that the patient takes the study pills on schedule over a period of three months.

Patients will undergo neuropsychological tests and an evaluation of the ability to live independently at each visit as well as laboratory evaluations, such as the taking of blood. Each visit will last approximately 3 hours. A total of 20 patients is being recruited to participate in this study at the University of Wisconsin.

Eligibility criteria: Inclusion Criteria:

* Postmenopausal women with Alzheimer's disease and without other dementias (diagnosed by study staff or from an outside clinic)
* Mini Mental Status Exam score greater than 15/30

Exclusion Criteria:

* History of deep vein thrombosis or blot clots
* Diabetes
* Active heart disease or stroke
* Liver problems including hepatitis
* Severe vision or hearing problems
* Tobacco use

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Madison
country: United States
facility: University of Wisconsin Memory Research Program
state: Wisconsin
Study officials:
affiliation: William S. Middleton VA Hospital, University of Wisconsin Memory Research Program
name: Sanjay Asthana, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Birge SJ, McEwen BS, Wise PM. Effects of estrogen deficiency on brain function. Implications for the treatment of postmenopausal women. Postgrad Med. 2001 Mar;Spec No:11-6.
citation: Zec RF, Trivedi MA. The effects of estrogen replacement therapy on neuropsychological functioning in postmenopausal women with and without dementia: a critical and theoretical review. Neuropsychol Rev. 2002 Jun;12(2):65-109. doi: 10.1023/a:1016880127635.
citation: Yaffe K. Estrogens, selective estrogen receptor modulators, and dementia: what is the evidence? Ann N Y Acad Sci. 2001 Dec;949:215-22. doi: 10.1111/j.1749-6632.2001.tb04024.x.