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Randomized controlled trial of atorvastatin in mild to moderate Alzheimer disease: LEADe
Feldman HH, Doody RS, Kivipelto M, Sparks DL, Waters DD, Jones RW, Schwam E, Schindler R et al.. Neurology, 2010-03-03
Topic: Amyloid, tau and blood-test diagnosis
Background There is some evidence that statins may have a protective and symptomatic benefit in Alzheimer disease (AD). The LEADe study is a randomized controlled trial (RCT) evaluating the efficacy and safety of atorvastatin in patients with mild to moderate AD. Methods This was an international, multicenter, double-blind, randomized, parallel-group study. Subjects had mild to moderate probable AD (Mini-Mental State Examination score 13-25), were aged 50-90 years, and were taking donepezil 10 mg daily for > or 3 months prior to screening. Entry low-density lipoprotein cholesterol levels (LDL-C) were > 95 and Results A total of 640 patients were randomized in the study. There were no significant differences in the coprimary endpoints of ADAS-cog or ADCS-CGIC or the secondary endpoints. Atorvastatin was generally well-tolerated. Conclusions In this large-scale randomized controlled trial evaluating statin therapy as a treatment for mild to moderate Alzheimer disease, atorvastatin was not associated with significant clinical benefit over 72 weeks. This treatment was generally well-tolerated without unexpected adverse events. Classification of evidence This study provides Class II evidence that intensive lipid lowering with atorvastatin 80 mg/day in patients with mild to moderate probable Alzheimer disease (aged 50-90), taking donepezil, with low-density lipoprotein cholesterol levels between 95 and 195 mg/dL over 72 weeks does not benefit cognition (as measured by Alzheimer's Disease Assessment Scale-Cognitive Subscale) (p = 0.26) or global function (as measured by Alzheimer's Disease Cooperative Study Clinical Global Impression of Change) (p = 0.73) compared with placebo.
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APA 7th
Feldman, H. H., Doody, R. S., Kivipelto, M., Sparks, D. L., Waters, D. D., Jones, R. W., et al. (2010). Randomized controlled trial of atorvastatin in mild to moderate Alzheimer disease: LEADe. Neurology. https://doi.org/10.1212/wnl.0b013e3181d6476a
Vancouver
Feldman HH, Doody RS, Kivipelto M, Sparks DL, Waters DD, Jones RW, et al. Randomized controlled trial of atorvastatin in mild to moderate Alzheimer disease: LEADe. Neurology. 2010. doi:10.1212/wnl.0b013e3181d6476a. PMID: 20200346.
BibTeX
@article{feldman2010-20200346,
author = {Feldman, H. H. and Doody, R. S. and Kivipelto, M. and Sparks, D. L. and Waters, D. D. and Jones, R. W. and Schwam, E. and Schindler, R. and others},
title = {{Randomized controlled trial of atorvastatin in mild to moderate Alzheimer disease: LEADe}},
journal = {Neurology},
year = {2010},
doi = {10.1212/wnl.0b013e3181d6476a},
pmid = {20200346},
url = {https://doi.org/10.1212/wnl.0b013e3181d6476a}
}
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Key findings
- Entry low-density lipoprotein cholesterol levels (LDL-C) were > 95 and Results A total of 640 patients were randomized in the study.
- There were no significant differences in the coprimary endpoints of ADAS-cog or ADCS-CGIC or the secondary endpoints.
- Conclusions In this large-scale randomized controlled trial evaluating statin therapy as a treatment for mild to moderate Alzheimer disease, atorvastatin was not associated with significant clinical benefit over 72 weeks.
- Classification of evidence This study provides Class II evidence that intensive lipid lowering with atorvastatin 80 mg/day in patients with mild to moderate probable Alzheimer disease (aged 50-90), taking donepezil, with low-density lipoprotein cholesterol levels between 95 and 195 mg/dL over 72 weeks does not benefit cognition (as measured by Alzheimer's Disease Assessment Scale-Cognitive Subscale) (p = 0.26) or global function (as measured by Alzheimer's Disease Cooperative Study Clinical Global Impression of Change) (p = 0.73) compared with placebo.
Why it matters
In this double-blind trial, 640 people with mild to moderate Alzheimer disease were randomized to atorvastatin 80 mg a day or placebo for 72 weeks. All were already taking donepezil and had LDL cholesterol between 95 and 195 mg/dL. The statin did not improve cognition (ADAS-Cog, p = 0.26) or overall function (ADCS-CGIC, p = 0.73) compared with placebo, and it was generally well tolerated. It tested treatment in people who already had Alzheimer's, so it does not address whether statins affect the risk of developing dementia.
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Study details
- Study designrandomized controlled trial
- Participants640
- Evidence strengthHigh
How this study scored 76/100
Published in a leading specialty journal, and it is a randomised controlled trial. Scored zero for 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 |
| 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 | 2010 — within 20 year(s) of the newest study here |
| Sample size | 2 / 4 | 640 participants |
| 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 (participant count stated) |
| Randomised / blinded | 2 / 2 | Randomised and blinded or placebo-controlled (as stated in the record) |
| Times cited | 6 / 7 | Cited 438 times (OpenAlex, 2026-10-10) |
| Citations per year | 4 / 5 | 24.3 citations a year over 18 year(s) since 2010 |
| Impact for its field and year | 5 / 6 | Cited 29.8× the average for papers of its field and year (OpenAlex FWCI) |
| Cited by studies here | 4 / 6 | Cited by 31 other studies in this library |
| Still being cited | 2 / 4 | Cited 44 times in 2024–2026 (2026 still in progress; OpenAlex) |
| Senior author's track record | 2 / 4 | Last-listed author Andrei Breazna: h-index 23 (OpenAlex, whole career) |
| Institution's track record | 2 / 3 | Baylor College of Medicine: institution h-index 1,607 (OpenAlex) |
| Multi-centre collaboration | 2 / 3 | OpenAlex lists 4 institution(s) in 3 countries |
| Indexed in PubMed | 2 / 2 | Indexed in PubMed (PMID 20200346) |
| Free to read | 0 / 2 | Behind a paywall — scores zero |
| Total | 76 / 100 | — |
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