Statins, Cholesterol and Cognitive Decline in Alzheimer's

April 29, 2025 updated by: Sara Garcia-Ptacek, Karolinska Institutet
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

2000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
      • Stockholm, Sweden
        • Karolinska Institutet

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

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

Description

Inclusion Criteria:

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

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cognitive decline
Time Frame: Through study completion, at least 1 year
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.
Through study completion, at least 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Karolinska Institutet

Collaborators

Region Stockholm

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2025

Primary Completion (Actual)

March 1, 2025

Study Completion (Actual)

March 1, 2025

Study Registration Dates

First Submitted

October 8, 2024

First Submitted That Met QC Criteria

October 8, 2024

First Posted (Actual)

October 10, 2024

Study Record Updates

Last Update Posted (Actual)

May 2, 2025

Last Update Submitted That Met QC Criteria

April 29, 2025

Last Verified

October 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2024-00178-02

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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