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Sponsored by: |
National Institute on Aging (NIA) |
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Information provided by: | National Institute on Aging (NIA) |
ClinicalTrials.gov Identifier: | NCT00687102 |
The purpose of this study is to assess the effects of tamoxifen and raloxifene on cognitive aging in selected cognitively-healthy women.
Condition | Intervention | Phase |
---|---|---|
Cognition Aging |
Drug: tamoxifen Drug: raloxifene |
Phase III |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Parallel Assignment, Efficacy Study |
Official Title: | Effects of Selective Estrogen Receptor Modulators on Cognitive Aging: Cognition in the Study of Tamoxifen and Raloxifene |
Enrollment: | 1498 |
Study Start Date: | October 2001 |
Study Completion Date: | March 2008 |
Primary Completion Date: | March 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Experimental
tamoxifen
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Drug: tamoxifen
oral tamoxifen plus placebo daily for 5 years
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2: Experimental
raloxifene
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Drug: raloxifene
oral raloxifene plus placebo daily for 5 years
|
Recent reports indicate that hormone therapy (HT) may have a protective effect on the aging brain. Although previous studies have examined the effects of HT on age-related cognitive changes, there is little information on the effect of a new class of estrogenic agents, selective estrogen receptor modulators (SERMs), on cognitive aging. The two most commonly prescribed SERMs are tamoxifen, for treatment and prevention of breast cancer, and raloxifene, for maintaining bone density. In the face of potential widespread use of SERMs in healthy women, information on the effects of these agents on memory and other cognitive functions is essential.
The principal goals of Co-STAR are to compare the effects of tamoxifen and raloxifene
Co-STAR results will be compared to results from the Women's Health Initiative Study of Cognitive Aging (WHISCA), a study involving 6-year longitudinal assessment of cognitive outcomes in 2969 women randomly assigned to receive active treatment (Premarin or Premarin plus medroxyprogesterone acetate) or placebo. A comparison of the Co-STAR treatment groups with the group of WHISCA participants receiving placebo will provide insights into the effects of SERMs relative to no treatment. A comparison of the Co-STAR treatment groups with WHISCA treatment groups receiving ET or ET plus progesterone will provide insights into the effects of SERMs relative to common HT treatments.
Co-STAR participants will be recruited from The National Cancer Institute's (NCI) Study of Tamoxifen and Raloxifene (STAR), a multi-center, 5-year, randomized clinical trial among 22,000 women at increased risk for breast cancer, to compare the effects of tamoxifen and raloxifene on risk for breast cancer.
Ages Eligible for Study: | 65 Years and older |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Principal Investigator: | Sally A. Shumaker, PhD | Wake Forest University |
Responsible Party: | Wake Forest University Health Sciences ( Sally A. Shumaker, Ph.D. ) |
Study ID Numbers: | IA0132, N01-AG-1-2106 |
Study First Received: | May 28, 2008 |
Last Updated: | May 29, 2008 |
ClinicalTrials.gov Identifier: | NCT00687102 |
Health Authority: | United States: Federal Government |
breast cancer Tamoxifen Raloxifene hormone therapy |
Raloxifene Breast Neoplasms Tamoxifen |
Estrogen Receptor Modulators Estrogen Antagonists Antineoplastic Agents, Hormonal Antineoplastic Agents Hormone Antagonists Therapeutic Uses |
Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists Bone Density Conservation Agents Selective Estrogen Receptor Modulators Pharmacologic Actions |