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

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ClinicalTrials.gov Identifier: NCT00687102
Recruitment Status : Completed
First Posted : May 30, 2008
Last Update Posted : August 4, 2011
Sponsor:
Collaborator:
Information provided by:

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

Condition or disease Intervention/treatment Phase
Cognition Aging Drug: tamoxifen Drug: raloxifene Phase 3

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 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.


Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1498 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Effects of Selective Estrogen Receptor Modulators on Cognitive Aging: Cognition in the Study of Tamoxifen and Raloxifene
Study Start Date : October 2001
Primary Completion Date : March 2008
Study Completion Date : March 2008

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: 1
tamoxifen
Drug: tamoxifen
oral tamoxifen plus placebo daily for 5 years
Other Name: Nolvadex
Experimental: 2
raloxifene
Drug: raloxifene
oral raloxifene plus placebo daily for 5 years
Other Name: Evista, Keoxifene


Outcome Measures

Primary Outcome Measures :
  1. California Verbal Learning Test (CVLT) [ Time Frame: Baseline and annually up to 4 years post treatment ]
  2. Benton Visual Retention Test (BVRT) Form D [ Time Frame: Baseline and annually up to 4 years post treatment ]

Secondary Outcome Measures :
  1. Modified Mini-Mental State Exam [ Time Frame: Baseline and annually up to 4 years post treatment ]
  2. Prospective Memory Test [ Time Frame: Baseline and annually up to 4 years post treatment ]
  3. Primary Mental Abilities Vocabulary Test [ Time Frame: Baseline and annually up to 4 years post treatment ]
  4. Card Rotations Test [ Time Frame: Baseline and annually up to 4 years post treatment ]
  5. Finger Tapping Test [ Time Frame: Baseline and annually up to 4 years post treatment ]
  6. CVLT Long Delay Recall and Recognition Trials [ Time Frame: Baseline and annually up to 4 years post treatment ]
  7. Letter (F,A,S) and Semantic (fruits, vegetables) Fluency Tests [ Time Frame: Baseline and annually up to 4 years post treatment ]
  8. Digit Span [ Time Frame: Baseline and annually up to 4 years post treatment ]
  9. Positive and Negative Affect Scale (PANAS) [ Time Frame: Baseline and annually up to 4 years post treatment ]
  10. Geriatric Depression Scale (GDS) [ Time Frame: Baseline and annually up to 4 years post treatment ]
  11. Women's Health Initiative (WHI) Sleep Disturbance Measure Version 5 [ Time Frame: Baseline and annually up to 4 years post treatment ]
  12. Menopausal Symptoms Checklist Version 5 [ Time Frame: Baseline and annually up to 4 years post treatment ]

Eligibility Criteria

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Ages Eligible for Study:   65 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00687102


  Show 134 Study Locations
Sponsors and Collaborators
Wake Forest University
National Institute on Aging (NIA)
Investigators
Principal Investigator: Sally A. Shumaker, PhD Wake Forest University Health Sciences
More Information

Publications:
Responsible Party: Sally A. Shumaker, Ph.D., Wake Forest Health Sciences
ClinicalTrials.gov Identifier: NCT00687102     History of Changes
Obsolete Identifiers: NCT00571857
Other Study ID Numbers: IA0132
1R13AG020218-01 ( U.S. NIH Grant/Contract )
N01-AG-1-2106
First Posted: May 30, 2008    Key Record Dates
Last Update Posted: August 4, 2011
Last Verified: May 2008

Keywords provided by Wake Forest University Health Sciences:
breast cancer
Tamoxifen
Raloxifene
hormone therapy

Additional relevant MeSH terms:
Tamoxifen
Raloxifene Hydrochloride
Selective Estrogen Receptor Modulators
Estrogen Receptor Modulators
Estrogen Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Bone Density Conservation Agents