Phase 3
N=1,498
Cognition in the Study of Tamoxifen and Raloxifene
Cognition · Aging
Bottom Line
View on ClinicalTrials.gov: NCT00687102 ↗Enrolled (actual)
1,498
Serious AEs
0.0%
Results posted
Jan 2018
Primary outcome: Primary: Mean Change From Baseline on the the Benton Visual Retention Test Scores by Treatment Group — -0.73; -1.41 Number of errors
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- tamoxifen (Drug); raloxifene (Drug)
- Age
- Older Adult · 65+ yrs
- Sex
- Female
- Sponsor
- Wake Forest University
- Primary completion
- Mar 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Change From Baseline on the the Benton Visual Retention Test Scores by Treatment Group |
-0.73; -1.41 | — |
| PRIMARY Mean Change From Baseline on the the California Verbal Learning Test Scores by Treatment Group |
-3.31; -1.89; -1.56; -1.74; -0.96; -0.36 | — |
| SECONDARY Mean Change From Baseline on the Letter Fluency and Semantic Fluency Scores by Treatment Group |
1.29; 1.51; -.51; -.56 | — |
| SECONDARY Mean Change From Baseline on Digit Span Test Scores by Treatment Group |
-0.02; -0.08; -0.16; -0.27 | — |
| SECONDARY Mean Change From Baseline on Card Rotations Test Scores by Treatment Group |
6.10; 5.40 | — |
| SECONDARY Mean Change From Baseline on the Finger Tapping Test Scores by Treatment Group |
0.26; -0.04; -0.18; -0.45 | — |
| SECONDARY Mean Change From Baseline on the Positive and Negative Affect Schedule Scores by Treatment Group |
-0.10; -0.04; 0.00; -0.06 | — |
| SECONDARY Mean Change From Baseline on the Geriatric Depression Scale Scores by Treatment Group |
0.57; 0.13 | — |
Summary
The purpose of this study is to assess the effects of tamoxifen and raloxifene on cognitive aging in selected cognitively-healthy women.
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT00687102). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.