Cognition in the Study of Tamoxifen and Raloxifene - Full Text View

Sponsored by:	National Institute on Aging (NIA)
Information provided by:	National Institute on Aging (NIA)
ClinicalTrials.gov Identifier:	NCT00687102

Purpose

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

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Cancer

Drug Information available for: Raloxifene Raloxifene hydrochloride Tamoxifen Tamoxifen citrate

U.S. FDA Resources

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

Further study details as provided by National Institute on Aging (NIA):

Primary Outcome Measures:

California Verbal Learning Test (CVLT) [ Time Frame: Baseline and annually up to 4 years post treatment ] [ Designated as safety issue: No ]
Benton Visual Retention Test (BVRT) Form D [ Time Frame: Baseline and annually up to 4 years post treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Modified Mini-Mental State Exam [ Time Frame: Baseline and annually up to 4 years post treatment ] [ Designated as safety issue: No ]
Prospective Memory Test [ Time Frame: Baseline and annually up to 4 years post treatment ] [ Designated as safety issue: No ]
Primary Mental Abilities Vocabulary Test [ Time Frame: Baseline and annually up to 4 years post treatment ] [ Designated as safety issue: No ]
Card Rotations Test [ Time Frame: Baseline and annually up to 4 years post treatment ] [ Designated as safety issue: No ]
Finger Tapping Test [ Time Frame: Baseline and annually up to 4 years post treatment ] [ Designated as safety issue: No ]
CVLT Long Delay Recall and Recognition Trials [ Time Frame: Baseline and annually up to 4 years post treatment ] [ Designated as safety issue: No ]
Letter (F,A,S) and Semantic (fruits, vegetables) Fluency Tests [ Time Frame: Baseline and annually up to 4 years post treatment ] [ Designated as safety issue: No ]
Digit Span [ Time Frame: Baseline and annually up to 4 years post treatment ] [ Designated as safety issue: No ]
Positive and Negative Affect Scale (PANAS) [ Time Frame: Baseline and annually up to 4 years post treatment ] [ Designated as safety issue: No ]
Geriatric Depression Scale (GDS) [ Time Frame: Baseline and annually up to 4 years post treatment ] [ Designated as safety issue: No ]
Women's Health Initiative (WHI) Sleep Disturbance Measure Version 5 [ Time Frame: Baseline and annually up to 4 years post treatment ] [ Designated as safety issue: No ]
Menopausal Symptoms Checklist Version 5 [ Time Frame: Baseline and annually up to 4 years post treatment ] [ Designated as safety issue: No ]

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	Drug: tamoxifen oral tamoxifen plus placebo daily for 5 years
2: Experimental raloxifene	Drug: raloxifene oral raloxifene plus placebo daily for 5 years

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.

Eligibility

Ages Eligible for Study:	65 Years and older
Genders 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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00687102

Show 134 Study Locations

Sponsors and Collaborators

National Institute on Aging (NIA)

Investigators

Principal Investigator:

Sally A. Shumaker, PhD

Wake Forest University

More Information

Publications:

Maki PM, Zonderman AB, Resnick SM. Enhanced verbal memory in nondemented elderly women receiving hormone-replacement therapy. Am J Psychiatry. 2001 Feb;158(2):227-33.

Resnick SM, Metter EJ, Zonderman AB. Estrogen replacement therapy and longitudinal decline in visual memory. A possible protective effect? Neurology. 1997 Dec;49(6):1491-7.

Resnick SM, Maki PM, Golski S, Kraut MA, Zonderman AB. Effects of estrogen replacement therapy on PET cerebral blood flow and neuropsychological performance. Horm Behav. 1998 Oct;34(2):171-82.

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

Keywords provided by National Institute on Aging (NIA):

breast cancer
Tamoxifen
Raloxifene
hormone therapy

Study placed in the following topic categories:

Raloxifene
Breast Neoplasms
Tamoxifen

Additional relevant MeSH terms:

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

ClinicalTrials.gov processed this record on January 30, 2009