Ignite Creation Date:
2024-05-05 @ 7:30 PM
Last Modification Date:
2024-10-26 @ 9:50 AM
Study NCT ID:
NCT00687102
Status:
COMPLETED
Last Update Posted:
2018-09-12
First Post:
2008-05-28
Brief Title:
Cognition in the Study of Tamoxifen and Raloxifene
Sponsor:
Wake Forest University
Organization:
Wake Forest University Health Sciences
Study Overview
Official Title:
Effects of Selective Estrogen Receptor Modulators on Cognitive Aging Cognition in the Study of Tamoxifen and Raloxifene
Status:
COMPLETED
Status Verified Date:
2018-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Co-STAR
Brief Summary:
The purpose of this study is to assess the effects of tamoxifen and raloxifene on cognitive aging in selected cognitively-healthy women
Detailed Description:
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
on age-associated declines in measures of verbal and nonverbal memory in women over age 65
other cognitive abilities and mood
with those resulting from more common forms of HT specifically ET conjugated equine estrogen and ET plus progesterone
Co-STAR results will be compared to results from the Womens 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 Institutes NCI Study of Tamoxifen and Raloxifene STAR NCT00003906 a multi-center 5-year randomized clinical trial among 22000 women at increased risk for breast cancer to compare the effects of tamoxifen and raloxifene on risk for breast cancer
The principal goals of Co-STAR are to compare the effects of tamoxifen and raloxifene
on age-associated declines in measures of verbal and nonverbal memory in women over age 65
other cognitive abilities and mood
with those resulting from more common forms of HT specifically ET conjugated equine estrogen and ET plus progesterone
Co-STAR results will be compared to results from the Womens 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 Institutes NCI Study of Tamoxifen and Raloxifene STAR NCT00003906 a multi-center 5-year randomized clinical trial among 22000 women at increased risk for breast cancer to compare the effects of tamoxifen and raloxifene on risk for breast cancer
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 1R13AG020218-01 | NIH | None | httpsreporternihgovquickSearch1R13AG020218-01 |