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Raloxifene for women with Alzheimer disease: A randomized controlled pilot trial
Henderson VW, Ala T, Sainani KL, Bernstein AL, Stephenson BS, Rosen AC, Farlow MR.. Neurology, 2015-11-04
Topic: Amyloid, tau and blood-test diagnosis
Objective To determine whether raloxifene, a selective estrogen receptor modulator, improves cognitive function compared with placebo in women with Alzheimer disease (AD) and to provide an estimate of cognitive effect. Methods This pilot study was conducted as a randomized, double-blind, placebo-controlled trial, with a planned treatment of 12 months. Women with late-onset AD of mild to moderate severity were randomly allocated to high-dose (120 mg) oral raloxifene or identical placebo provided once daily. The primary outcome compared between treatment groups at 12 months was change in the Alzheimer's Disease Assessment Scale, cognitive subscale (ADAS-cog). Results Forty-two women randomized to raloxifene or placebo were included in intent-to-treat analyses (mean age 76 years, range 68-84), and 39 women contributed 12-month outcomes. ADAS-cog change scores at 12 months did not differ significantly between treatment groups (standardized difference 0.03, 95% confidence interval -0.39 to 0.44, 2-tailed p = 0.89). Raloxifene and placebo groups did not differ significantly on secondary analyses of dementia rating, activities of daily living, behavior, or a global cognition composite score. Caregiver burden and caregiver distress were similar in both groups. Conclusions Results on the primary outcome showed no cognitive benefits in the raloxifene-treated group. Classification of evidence This study provides Class I evidence that for women with AD, raloxifene does not have a significant cognitive effect. The study lacked the precision to exclude a small effect.
Cite this study APA, Vancouver, BibTeX · download .bib or .ris
APA 7th
Henderson, V. W., Ala, T., Sainani, K. L., Bernstein, A. L., Stephenson, B. S., Rosen, A. C., et al. (2015). Raloxifene for women with Alzheimer disease: A randomized controlled pilot trial. Neurology. https://doi.org/10.1212/wnl.0000000000002171
Vancouver
Henderson VW, Ala T, Sainani KL, Bernstein AL, Stephenson BS, Rosen AC, et al. Raloxifene for women with Alzheimer disease: A randomized controlled pilot trial. Neurology. 2015. doi:10.1212/wnl.0000000000002171. PMID: 26537053.
BibTeX
@article{henderson2015-26537053,
author = {Henderson, V. W. and Ala, T. and Sainani, K. L. and Bernstein, A. L. and Stephenson, B. S. and Rosen, A. C. and Farlow, M. R.},
title = {{Raloxifene for women with Alzheimer disease: A randomized controlled pilot trial}},
journal = {Neurology},
year = {2015},
doi = {10.1212/wnl.0000000000002171},
pmid = {26537053},
url = {https://doi.org/10.1212/wnl.0000000000002171}
}
Built from the record alzhub holds for this paper, not looked up. Volume, issue and page numbers are not held in the record. The record names 7 authors; APA and Vancouver show the first six, BibTeX and the downloads carry all of them. Check the citation against the original before you use it.
Key findings
- Objective To determine whether raloxifene, a selective estrogen receptor modulator, improves cognitive function compared with placebo in women with Alzheimer disease (AD) and to provide an estimate of cognitive effect.
- Results Forty-two women randomized to raloxifene or placebo were included in intent-to-treat analyses (mean age 76 years, range 68-84), and 39 women contributed 12-month outcomes.
- ADAS-cog change scores at 12 months did not differ significantly between treatment groups (standardized difference 0.03, 95% confidence interval -0.39 to 0.44, 2-tailed p = 0.89).
- Raloxifene and placebo groups did not differ significantly on secondary analyses of dementia rating, activities of daily living, behavior, or a global cognition composite score.
- Conclusions Results on the primary outcome showed no cognitive benefits in the raloxifene-treated group.
Why it matters
In this small pilot trial of 42 women with mild-to-moderate Alzheimer's disease, raloxifene showed no significant cognitive benefit compared with placebo. This drug did not help treat Alzheimer's disease in this study.
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Study details
- Evidence strengthHigh
How this study scored 67/100
Published in a leading specialty journal, and it is a randomised controlled trial. Scored zero for sample size and effect reported because the record does not state it.
| Component | Points | Why |
|---|---|---|
| Journal tier | 9 / 10 | Tier 2 — leading specialty journal (Neurology) |
| Journal's citation record | 4 / 4 | Neurology: journal h-index 525 (OpenAlex, 2026-10-29) |
| Study design | 11 / 12 | A randomised controlled trial (from PubMed type “Randomized Controlled Trial”) |
| Strength of evidence | 5 / 5 | Rated “high” in our summary |
| Peer-review validation | 10 / 10 | Peer-reviewed. Published as an article in a named peer-reviewed journal. |
| How recent | 1 / 5 | 2015 — within 20 year(s) of the newest study here |
| Sample size | 0 / 4 | Participant count not stated — scores zero (not stated in the record — scored 0) |
| Effect reported | 0 / 3 | No effect size reported — scores zero (not stated in the record — scored 0) |
| Studied in people | 3 / 3 | Studied in people (pubmed indexes it as a clinical or observational study) |
| Randomised / blinded | 2 / 2 | Randomised and blinded or placebo-controlled (as stated in the record) |
| Times cited | 4 / 7 | Cited 50 times (OpenAlex, 2026-10-10) |
| Citations per year | 2 / 5 | 3.8 citations a year over 13 year(s) since 2015 |
| Impact for its field and year | 3 / 6 | Cited 3.6× the average for papers of its field and year (OpenAlex FWCI) |
| Cited by studies here | 1 / 6 | Cited by 2 other studies in this library |
| Still being cited | 1 / 4 | Cited 11 times in 2024–2026 (2026 still in progress; OpenAlex) |
| Senior author's track record | 4 / 4 | Last-listed author Martin Rhys Farlow: h-index 118 (OpenAlex, whole career) |
| Institution's track record | 3 / 3 | Stanford University: institution h-index 2,684 (OpenAlex) |
| Multi-centre collaboration | 2 / 3 | OpenAlex lists 6 institution(s) in 1 country |
| Indexed in PubMed | 2 / 2 | Indexed in PubMed (PMID 26537053) |
| Free to read | 0 / 2 | Behind a paywall — scores zero |
| Total | 67 / 100 | — |
What each of these 20 components measures, and what this score is not →
Read the original
- DOI: 10.1212/wnl.0000000000002171
- PubMed: 26537053
- Original source →
- Free full text: PubMed Central →
Full text: free to read — PubMed Central lists this copy as free to read: the link above (checked 10 Oct 2026).
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