Cognition in the Study of Tamoxifen and Raloxifene (Co-STAR)

Wake Forest University (WFU)

Status and phase: Completed; Phase 3

Conditions: Aging; Cognition

Treatments: Drug: tamoxifen; Drug: raloxifene

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00687102

1R13AG020218-01 (U.S. NIH Grant/Contract)

IA0132

Details and patient eligibility

About

The purpose of this study is to assess the effects of tamoxifen and raloxifene on cognitive aging in selected cognitively-healthy women.

Full 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 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) NCT00003906, 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.

Enrollment: 1,498 patients

Sex: Female

Ages: 65+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Women enrolled in STAR trial at a site participating in Co-STAR
• 65 years of age or older
• Have been randomized into STAR but have not started taking the study drug OR enrolled in STAR for a minimum of one year
• Have not been diagnosed with dementia
• Have signed a separate consent document for the Co-STAR Study
• Previous diagnoses of chronic neurologic disease (Parkinson's disease, stroke, epilepsy, multiple sclerosis), history of head injury, depression, alcohol addiction, drug addiction, and other neurologic or psychiatric conditions will be recorded but will not serve as exclusion factors for this study

Exclusion criteria

• Not enrolled in the STAR Trial
• Younger than 65 years of age
• Diagnosed with dementia

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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1,498 participants in 2 patient groups

Star participants assigned to Tamoxifen

Experimental group

Description:

Participants in the parent study, STAR assigned to Tamoxifen who were 65 or older at time of enrollment.

Treatment:

Drug: tamoxifen

Star participants assigned to Raloxifene

Experimental group

Description:

Participants in the parent study, STAR assigned to Raloxifene who were 65 or older at time of enrollment.

Treatment:

Drug: raloxifene