Alzheimer DementiaNCT06635252
Statins, Cholesterol and Cognitive Decline in Alzheimer's
An observational study of Alzheimer Dementia and Statins, run by Karolinska Institutet at 1 site in Sweden.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Alzheimer Dementia, Statins
- What is being tested?
- STA 4783
- How many people
- 2,000 participants
- Where
- 1 siteSweden
- Study dates
- 1 Jan 2025to 1 Mar 2025
- How long will I take part?
- 1 Year
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- All patients with AD and mixed dementia registered in SveDem and from SCREAM.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
- Being tested
- STA 4783
- Medical subject headings
- Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
STA 4783Drug
Use of statins will be identified from Prescribed Drug register within 6 months before dementia diagnosis or each follow-up date
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: STA 4783 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Through study completion, at least 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2024
- Study start1 Jan 2025
- Primary completion1 Mar 2025
- Study completion1 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alzheimer DementiaStudies of the same condition, open and under way.
- More trials run by Karolinska InstitutetThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,000 participants (actual)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Collaborators
- Region Stockholm
- Responsible party
- Principal investigator, Sara Garcia-Ptacek, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06635252
- Sponsor's protocol ID
- 2024-00178-02
- Status last verified
- Oct 2024
- First submitted
- 8 Oct 2024
- Last updated
- 2 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Statins, Cholesterol and Cognitive Decline in Alzheimer's
- ClinicalTrials.gov ID
- NCT06635252
- Acronym / sponsor ID
- 2024-00178-02
- Conditions
- Alzheimer Dementia, Statins
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,000 participants (actual)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Collaborators
- Region Stockholm
- Study start
- 1 Jan 2025 (actual)
- Primary completion
- 1 Mar 2025 (actual)
- Study completion
- 1 Mar 2025 (actual)
- First posted
- 10 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with Alzheimer's disease | – | Drug: STA 4783Prospective 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. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (1 listed)
- All patients with AD and mixed dementia registered in SveDem and from SCREAM.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| STA 4783Use of statins will be identified from Prescribed Drug register within 6 months before dementia diagnosis or each follow-up date | Drug | Patients with Alzheimer's disease |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 May 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Alzheimer Dementia and Statins, run by Karolinska Institutet at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cognitive decline (time frame: Through study completion, at least 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 May 2025.