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Cognitive and Neurophysiological Effects of Raloxifene in Alzheimer's Disease

Cognitive and Neurophysiological Effects of Raloxifene in Alzheimer's Disease

Status
Completed
Phases
Phase 2Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00065767
Enrollment
20
Registered
2003-08-04
Start date
2001-09-30
Completion date
2005-03-31
Last updated
2015-10-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Alzheimer Disease

Keywords

Alzheimer disease, Postmenopausal women, Hormone therapy

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.

Interventions

DRUGRaloxifene

Sponsors

National Institute on Aging (NIA)
CollaboratorNIH
University of Wisconsin, Madison
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE

Eligibility

Sex/Gender
FEMALE
Age
55 Years to 90 Years
Healthy volunteers
No

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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026