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CompletedNCT06635252Updated May 2, 2025

Statins, Cholesterol and Cognitive Decline in Alzheimer's

An observational study in Alzheimer Dementia and Statins, sponsored by Karolinska Institutet. Completed at 1 site in Sweden. Open to participants aged 40 Years and older. Per ClinicalTrials.gov, last updated 2025-05-02.

Sponsored by Karolinska Institutet · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
2,000
Ages
40 Years and older
Sex
All
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Study summary

Disturbances in brain cholesterol homeostasis may be involved in the pathogenesis of Alzheimer's disease (AD). Lipid-lowering medications could interfere with neurodegenerative processes in AD through cholesterol metabolism or other mechanisms. The investigators aim to estimate the causal effect of statins on cognitive function measured by MMSE and to identify the mediating or modifying effect of cholesterol between statins and cognitive function in patients with Alzheimer's disease.

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Conditions studied

  • Alzheimer Dementia
  • Statins
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In context

Alzheimer Disease

3,678 studies on the registry are indexed under Alzheimer Disease; 872 are open to participants now.

This study's enrollment of 2,000 is above the median of 200 across 751 observational studies indexed under Alzheimer Disease.

Browse Alzheimer Disease studies →

Lead sponsor

Karolinska Institutet is the lead sponsor of 1,113 studies on the registry; 267 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
40 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Prospective cohort study based on data from the Stockholm Creatinine Measurements (SCREAM) project, linking laboratory data with SveDem-the Swedish Registry for Dementia Cognitive disorders, the National Patient Registry, the Swedish Prescribed Drug Registry, The Swedish Cause of Death Register and Health Insurance and Labour Market Studies (LISA). Dates between May 1, 2007, and October 16, 2018

Inclusion criteria

All patients with AD and mixed dementia registered in SveDem and from SCREAM.

Exclusion criteria

Exclusion Criteria:

  • All patients with a missing MMSE score at diagnosis date will be excluded from the analyses.
  • Patients with at least one measurement of low-density lipoprotein cholesterol (LDL-C) within 1 year before dementia diagnosis.
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
2,000 participants (actual)
Target follow-up
1 Year
Patient registry
Yes

Groups and cohorts

  • Patients with Alzheimer's disease

    Prospective cohort study based on data from the Stockholm Creatinine Measurements (SCREAM) project. Patients diagnosed with AD and mixed dementia and registered in the Swedish Registry for Cognitive/Dementia Diseases are included.

    Drug: STA 4783

Interventions

  • DrugSTA 4783

    Use of statins will be identified from Prescribed Drug register within 6 months before dementia diagnosis or each follow-up date

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What researchers measure

Primary outcomes

  1. Cognitive decline

    The data on cognitive change will be assessed by Mini Mental State Examination (MMSE) score. The MMSE score ranges from 0 and 30. Higher scores mean a better outcome.

    Time frame: Through study completion, at least 1 year

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Study locations

1 site
  • Karolinska Institutet
    Stockholm, Sweden
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 2, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06635252
Lead sponsor
Karolinska Institutet
Collaborators
Region Stockholm
Responsible party
Sara Garcia-Ptacek (Assistant Professor | Docent, Karolinska Institutet) — Principal investigator
First posted
Oct 10, 2024
Start date
Jan 1, 2025
Primary completion
Mar 1, 2025
Completion
Mar 1, 2025
Last update
May 2, 2025

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2024. You cannot join it, but the record below documents what was studied.

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