Summary
Simvastatin has reached the approved stage (maximum clinical phase 4) for at least one indication, so its use in Alzheimer's Disease and Other Dementias would be drug repurposing rather than first-in-human development. This does not mean it is approved for Alzheimer's Disease and Other Dementias. No registered clinical trial in this database tests Simvastatin specifically in Alzheimer's Disease and Other Dementias. The evidence below comes from published literature only, so any clinical signal has not yet been tested prospectively against this condition in a registered study. The literature layer holds 13 publications for this pair: 5 Cochrane reviews, 1 meta-analysis, 2 randomised controlled trial publications and 5 clinical trial publications. Publication years run from 2001 to 2022. Because at least one synthesis-level source exists (systematic review, meta-analysis or Cochrane review), this pair has been assessed beyond single studies, although the synthesis may concern a different indication.
The RepurpOS disease-intelligence file for Alzheimer's Disease and Other Dementias ranks 705 candidate therapeutics from Open Targets, ChEMBL, DGIdb and PubMed; only a minority carry direct clinical evidence, and this page covers one of those. Spontaneous remission context recorded for the condition: Progressive and irreversible by definition; MMSE decline 1.07-3.4 points/year untreated; no spontaneous remission.
Evidence table
| Evidence tier | A · Strong |
|---|---|
| Evidence score | 50.0 (trials 0.0, literature 30.0, tier 15, approved bonus 5.0) |
| Registered trials | 0 total: 0 recruiting, 0 active / not yet recruiting, 0 completed, 0 other |
| Linked publications | 13 (5 Cochrane reviews, 5 clinical trial publications, 2 randomised controlled trial publications, 1 meta-analysis) |
| Agent type | Drug (Small molecule) |
| Development stage (any indication) | Approved |
| Mechanism / class | Not recorded |
| Data sources | DGIdb |
| Linked via biomarker / target | ABCA1 |
How the evidence score is calculated
- Each registered trial scores by status (recruiting / active / enrolling 3, completed 2.5, not yet recruiting 2, unknown 1, terminated / withdrawn / suspended 0.5) plus a phase bonus (phase 3-4 +2, phase 2 +1, phase 1 +0.5). The trial component is capped at 30.
- Each literature item scores by design (Cochrane review 5, meta-analysis 4, systematic review 3, RCT 3, clinical trial publication 2, curated reference 1.5, other PubMed record 1). The literature component is capped at 30.
- The existing evidence tier adds 15 (A / Strong), 10 (B / Moderate), 5 (C / Preliminary) or 0 (D / Anecdotal).
- Agents approved for any indication (max clinical phase 4) add 5, because an approved agent has an established safety profile that lowers the barrier to repurposing trials.
- The score ranks what has been studied, not what works. It does not read effect sizes or directions of effect.
Registered clinical trials
No registered trial links Simvastatin to Alzheimer's Disease and Other Dementias in the current OSMF trial extract.
Published literature
- Clinical trial publication Effects of Simvastatin on Plasma Amyloid-β Transport in Patients with Hyperlipidemia: A 12-Week Randomized, Double-Blind, Placebo-Controlled TrialWei S, Dang L, Gao F et al. · Journal of Alzheimer's disease : JAD · 2022 · PMID 36120775
- Clinical trial publication Effect of simvastatin on CSF Alzheimer disease biomarkers in cognitively normal adultsLi G, Mayer CL, Morelli D et al. · Neurology · 2017 · PMID 28821686
- Clinical trial publication Simvastatin ameliorate memory deficits and inflammation in clinical and mouse model of Alzheimer's disease via modulating the expression of miR-106bHuang W, Li Z, Zhao L et al. · Biomedicine & pharmacotherapy = Biomedecine & pharmacotherapie · 2017 · PMID 28528185
- Meta-analysis Evidence for benefit of statins to modify cognitive decline and risk in Alzheimer's diseaseGeifman N, Brinton RD, Kennedy RE et al. · Alzheimer's research & therapy · 2017 · PMID 28212683
- Cochrane review Statins for the prevention of dementiaMcGuinness B, Craig D, Bullock R et al. · The Cochrane database of systematic reviews · 2016 · PMID 26727124
- Clinical trial publication LDL-lipids from patients with hypercholesterolaemia and Alzheimer's disease are inflammatory to microvascular endothelial cells: mitigation by statin interventionDias HK, Brown CL, Polidori MC et al. · Clinical science (London, England : 1979) · 2015 · PMID 26399707
- Clinical trial publication Longitudinal plasma amyloid beta in Alzheimer's disease clinical trialsDonohue MC, Moghadam SH, Roe AD et al. · Alzheimer's & dementia : the journal of the Alzheimer's Association · 2015 · PMID 25301682
- Randomized controlled trial Toward onset prevention of cognitive decline in adults with Down syndrome (the TOP-COG study): study protocol for a randomized controlled trialCooper SA, Caslake M, Evans J et al. · Trials · 2014 · PMID 24888381
- Randomized controlled trial A randomized, double-blind, placebo-controlled trial of simvastatin to treat Alzheimer diseaseSano M, Bell KL, Galasko D et al. · Neurology · 2011 · PMID 21795660
- Cochrane review Statins for the treatment of dementiaMcGuinness B, O'Hare J, Craig D et al. · The Cochrane database of systematic reviews · 2010 · PMID 20687089
- Cochrane review Can statins prevent or help treat Alzheimer's disease?McGuinness B, Passmore P · Journal of Alzheimer's disease : JAD · 2010 · PMID 20182019
- Cochrane review Statins for the prevention of dementiaMcGuinness B, Craig D, Bullock R et al. · The Cochrane database of systematic reviews · 2009 · PMID 19370582
- Cochrane review Statins for the prevention of Alzheimer's diseaseScott HD, Laake K · The Cochrane database of systematic reviews · 2001 · PMID 11687176
Mechanism and notes
No mechanism of action is recorded for this pair in the source databases.
OSMF's existing evidence tier for this pair is A (Strong), derived from the strength of the disease association recorded in DGIdb, in this case via the biomarker or target ABCA1. The tier describes how well the drug-disease link is documented, not how well the drug works.
Frequently asked questions
Is Simvastatin approved for Alzheimer's Disease and Other Dementias?
Simvastatin has reached the approved stage (maximum clinical phase 4) for at least one indication, so its use in Alzheimer's Disease and Other Dementias would be drug repurposing rather than first-in-human development. This does not mean it is approved for Alzheimer's Disease and Other Dementias. Approval status for the specific indication should always be confirmed with the relevant regulator and prescribing information.
Is Simvastatin in clinical trials for Alzheimer's Disease and Other Dementias?
No registered clinical trial in this database tests Simvastatin specifically in Alzheimer's Disease and Other Dementias. The evidence below comes from published literature only, so any clinical signal has not yet been tested prospectively against this condition in a registered study.
What does the evidence show for Simvastatin in Alzheimer's Disease and Other Dementias?
Synthesis-level literature links Simvastatin to Alzheimer's Disease and Other Dementias, but no registered trial in this database tests the pair, so the evidence is observational, pooled from other indications, or pre-dates registry practice. OSMF's existing evidence tier for this pair is A (Strong), derived from the strength of the disease association recorded in DGIdb, in this case via the biomarker or target ABCA1. The tier describes how well the drug-disease link is documented, not how well the drug works.
Cite this page
Data: ClinicalTrials.gov, PubMed, Open Targets, ChEMBL, DGIdb and the OSMF therapeutic agent database. Last updated 2026-07-05. Page built 2026-10-07.