Statins, Cholesterol and Cognitive Decline in Alzheimer's

NCT06635252 | Completed DMC FDA Drug

• 1 other identifier: 2024-00178-02
• Study Type: observational
• Target: 2,000
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Alzheimer Dementia; Statins

Outcome Measures

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.

  Through study completion, at least 1 year

Study Arms (1)

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

STA 4783 DRUG

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

Patients with Alzheimer's disease

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Karolinska Institutet: lead
• Region Stockholm: collaborator

Study Sites (1)

Karolinska Institutet

Stockholm, Sweden, Sweden

Location

MeSH Terms

Conditions

Alzheimer Disease

Interventions

elesclomol

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor | Docent

Study Record Dates

• First Submitted: October 8, 2024
• First Posted: October 10, 2024
• Study Start: January 1, 2025
• Primary Completion: March 1, 2025
• Study Completion: March 1, 2025
• Last Updated: May 2, 2025

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)