Alzheimer DementiaNCT05817188
Medication Repurposing to Stop Cognitive Decline in Dementia
An observational study of Alzheimer Dementia and Dementia Disorders, run by Karolinska Institutet at 1 site in Sweden.
Trial summary
Dementia creates a great personal and societal burden and there are currently no treatments to stop memory loss. Many patients with dementia take medications to treat other conditions, e.g. high blood pressure and cholesterol. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Alzheimer Dementia, Dementia Disorders
- How many people
- 100,000 participants
- Where
- 1 siteSweden
- Study dates
- 1 Jan 2023to 1 Mar 2025
- 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: This study includes >100,000 patients in SveDem and ca. 144,000 measures of Mini-mental State Examination (MMSE) including base registration and follow-ups. Our current merged dataset contains 80,004 individuals, but we periodically conduct new merges which will increase the sample size in the future: this may be necessary for rarer medications.
Who may be able to join
- All patients with dementia registered in SveDem.
Who cannot join
- Lack of Swedish personal identification number or coordination number.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Translational Identification of Medication Repurposing Candidates to Slow Cognitive Decline in Dementia
Dementia creates a great personal and societal burden and there are currently no treatments to stop memory loss. Many patients with dementia take medications to treat other conditions, e.g. high blood pressure and cholesterol. Some of these medications may have central effects on the pathophysiological processes leading to dementia.
Medication repurposing is a cost and time-effective way to discover new treatments. Swedish registers are a unique tool to detect medication candidates for repurposing. The Swedish Dementia Registry (SveDem) has >100000 patients and ca. 144000 measures of cognition over time (measured with the Mini-Mental State Examination-MMSE), making it perfect to examine whether certain medications are associated with less cognitive decline in patients with dementia. Cholesterol and kidney function affect treatment and cognition and are available for 25000 patients. The investigators propose a study combining traditional cohort studies and newer artificial intelligence (machine learning) techniques to detect medications associated with slower cognitive decline in patients from SveDem. The investigators will test pre-specified hypotheses since the investigators suspect specific medications are better candidates to prevent cognitive decline, but the investigators will also let the machine learning algorithms explore the data to find associations that the investigators do not suspect in advance. Finally, the candidate medications will be tested in animal and cellular models to determine the mechanisms of their effects.
- Conditions
- Alzheimer Dementia, Dementia Disorders
- Being tested
- No intervention
- Keywords
- medication, repurposing, cognitive decline, dementia, Mini-Mental State Examination
- Medical subject headings
- Alzheimer Disease, Cognitive Dysfunction, Dementia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
No intervention was applied
| Study group | Role | What they receive |
|---|---|---|
| Dementia patients | This register-based project will include all patients diagnosed with dementia and registered in the Swedish Registry for Cognitive/Dementia Diseases. Identification of cases and control and data collation are carried out by Swedish authorities. Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cognitive decline
The data on cognitive decline 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
Secondary outcomes (2)
Rate of nursing home placement
Data will be obtained from the social services registry.
Measured: Through study completion, at least 1 year
Mortality
Data about date and cause(s) of death will be collected from The Cause of Death Register.
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 posted18 Apr 2023
- Study start1 Jan 2023
- 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.
- Publications (9)Papers the sponsor has linked to this study.
- 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
- 100,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Collaborators
- KTH Royal Institute of Technology, Region Stockholm
- Responsible party
- Principal investigator, Sara Garcia-Ptacek, Karolinska Institutet
- Investigators
- Sara Garcia-Ptacek, MD,PhD, Principal investigator, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05817188
- Sponsor's protocol ID
- 2022-01425
- Status last verified
- Apr 2023
- First submitted
- 4 Apr 2023
- Last updated
- 2 May 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Religa D, Fereshtehnejad SM, Cermakova P, Edlund AK, Garcia-Ptacek S, Granqvist N, Hallback A, Kawe K, Farahmand B, Kilander L, Mattsson UB, Nagga K, Nordstrom P, Wijk H, Wimo A, Winblad B, Eriksdotter M. SveDem, the Swedish Dementia Registry - a tool for improving the quality of diagnostics, treatment and care of dementia patients in clinical practice. PLoS One. 2015 Feb 19;10(2):e0116538. doi: 10.1371/journal.pone.0116538. eCollection 2015.
PubMed 25695768Garcia-Ptacek S, Kareholt I, Farahmand B, Cuadrado ML, Religa D, Eriksdotter M. Body-mass index and mortality in incident dementia: a cohort study on 11,398 patients from SveDem, the Swedish Dementia Registry. J Am Med Dir Assoc. 2014 Jun;15(6):447.e1-7. doi: 10.1016/j.jamda.2014.03.001. Epub 2014 Apr 8.
PubMed 24721339Roheger M, Zupanic E, Kareholt I, Religa D, Kalbe E, Eriksdotter M, Garcia-Ptacek S. Mortality and nursing home placement of dementia patients in rural and urban areas: a cohort study from the Swedish Dementia Registry. Scand J Caring Sci. 2018 Dec;32(4):1308-1313. doi: 10.1111/scs.12574. Epub 2018 Apr 14.
PubMed 29656469Garcia-Ptacek S, Modeer IN, Kareholt I, Fereshtehnejad SM, Farahmand B, Religa D, Eriksdotter M. Differences in diagnostic process, treatment and social Support for Alzheimer's dementia between primary and specialist care: resultss from the Swedish Dementia Registry. Age Ageing. 2017 Mar 1;46(2):314-319. doi: 10.1093/ageing/afw189.
PubMed 27810851Cermakova P, Nelson M, Secnik J, Garcia-Ptacek S, Johnell K, Fastbom J, Kilander L, Winblad B, Eriksdotter M, Religa D. Living Alone with Alzheimer's Disease: Data from SveDem, the Swedish Dementia Registry. J Alzheimers Dis. 2017;58(4):1265-1272. doi: 10.3233/JAD-170102.
PubMed 28550260Garcia-Ptacek S, Kareholt I, Cermakova P, Rizzuto D, Religa D, Eriksdotter M. Causes of Death According to Death Certificates in Individuals with Dementia: A Cohort from the Swedish Dementia Registry. J Am Geriatr Soc. 2016 Nov;64(11):e137-e142. doi: 10.1111/jgs.14421. Epub 2016 Nov 1.
PubMed 27801938Mo M, Abzhandadze T, Hoang MT, Sacuiu S, Jurado PG, Pereira JB, Naia L, Kele J, Maioli S, Xu H, Eriksdotter M, Garcia-Ptacek S. Antidepressant use and cognitive decline in patients with dementia: a national cohort study. BMC Med. 2025 Feb 25;23(1):82. doi: 10.1186/s12916-025-03851-3.
PubMed 39994788Grau-Jurado P, Mostafaei S, Xu H, Mo M, Petek B, Kalar I, Naia L, Kele J, Maioli S, Pereira JB, Eriksdotter M, Chatterjee S, Garcia-Ptacek S. Medications and cognitive decline in Alzheimer's disease: Cohort cluster analysis of 15,428 patients. J Alzheimers Dis. 2025 Feb;103(3):931-940. doi: 10.1177/13872877241307870. Epub 2025 Jan 8.
PubMed 39772858Petek B, Habel H, Xu H, Villa-Lopez M, Kalar I, Hoang MT, Maioli S, Pereira JB, Mostafaei S, Winblad B, Gregoric Kramberger M, Eriksdotter M, Garcia-Ptacek S. Statins and cognitive decline in patients with Alzheimer's and mixed dementia: a longitudinal registry-based cohort study. Alzheimers Res Ther. 2023 Dec 20;15(1):220. doi: 10.1186/s13195-023-01360-0.
PubMed 38115091
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
- Translational Identification of Medication Repurposing Candidates to Slow Cognitive Decline in Dementia
- ClinicalTrials.gov ID
- NCT05817188
- Acronym / sponsor ID
- 2022-01425
- Conditions
- Alzheimer Dementia, Dementia Disorders
- Keywords
- medication, repurposing, cognitive decline, dementia, Mini-Mental State Examination
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100,000 participants (actual)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Collaborators
- KTH Royal Institute of Technology, Region Stockholm
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 1 Mar 2025 (actual)
- Study completion
- 1 Mar 2025 (actual)
- First posted
- 18 Apr 2023 (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.
Dementia creates a great personal and societal burden and there are currently no treatments to stop memory loss. Many patients with dementia take medications to treat other conditions, e.g. high blood pressure and cholesterol. Some of these medications may have central effects on the pathophysiological processes leading to dementia.
Medication repurposing is a cost and time-effective way to discover new treatments. Swedish registers are a unique tool to detect medication candidates for repurposing. The Swedish Dementia Registry (SveDem) has >100000 patients and ca. 144000 measures of cognition over time (measured with the Mini-Mental State Examination-MMSE), making it perfect to examine whether certain medications are associated with less cognitive decline in patients with dementia. Cholesterol and kidney function affect treatment and cognition and are available for 25000 patients. The investigators propose a study combining traditional cohort studies and newer artificial intelligence (machine learning) techniques to detect medications associated with slower cognitive decline in patients from SveDem. The investigators will test pre-specified hypotheses since the investigators suspect specific medications are better candidates to prevent cognitive decline, but the investigators will also let the machine learning algorithms explore the data to find associations that the investigators do not suspect in advance. Finally, the candidate medications will be tested in animal and cellular models to determine the mechanisms of their effects.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Dementia patients | – | Other: No interventionThis register-based project will include all patients diagnosed with dementia and registered in the Swedish Registry for Cognitive/Dementia Diseases. Identification of cases and control and data collation are carried out by Swedish authorities. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This study includes >100,000 patients in SveDem and ca. 144,000 measures of Mini-mental State Examination (MMSE) including base registration and follow-ups. Our current merged dataset contains 80,004 individuals, but we periodically conduct new merges which will increase the sample size in the future: this may be necessary for rarer medications.
Key inclusion criteria (1 listed)
- All patients with dementia registered in SveDem.
Key exclusion criteria (1 listed)
- Lack of Swedish personal identification number or coordination number.
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 |
|---|---|---|
| No interventionNo intervention was applied | Other | Dementia patients |
Primary outcome
Cognitive decline
Time frame: Through study completion, at least 1 year
The data on cognitive decline will be assessed by Mini Mental State Examination (MMSE) score. The MMSE score ranges from 0 and 30. Higher scores mean a better outcome.
2 secondary outcomes
Rate of nursing home placement
Time frame: Through study completion, at least 1 year
Mortality
Time frame: Through study completion, at least 1 year
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.
- Background: PubMed 25695768Religa D, Fereshtehnejad SM, Cermakova P, Edlund AK, Garcia-Ptacek S, Granqvist N, Hallback A, Kawe K, Farahmand B, Kilander L, Mattsson UB, Nagga K, Nordstrom P, Wijk H, Wimo A, Winblad B, Eriksdotter M. SveDem, the Swedish Dementia Registry - a tool for improving the quality of diagnostics, treatment and care of dementia patients in clinical practice. PLoS One. 2015 Feb 19;10(2):e0116538. doi: 10.1371/journal.pone.0116538. eCollection 2015.
- Background: PubMed 24721339Garcia-Ptacek S, Kareholt I, Farahmand B, Cuadrado ML, Religa D, Eriksdotter M. Body-mass index and mortality in incident dementia: a cohort study on 11,398 patients from SveDem, the Swedish Dementia Registry. J Am Med Dir Assoc. 2014 Jun;15(6):447.e1-7. doi: 10.1016/j.jamda.2014.03.001. Epub 2014 Apr 8.
- Background: PubMed 29656469Roheger M, Zupanic E, Kareholt I, Religa D, Kalbe E, Eriksdotter M, Garcia-Ptacek S. Mortality and nursing home placement of dementia patients in rural and urban areas: a cohort study from the Swedish Dementia Registry. Scand J Caring Sci. 2018 Dec;32(4):1308-1313. doi: 10.1111/scs.12574. Epub 2018 Apr 14.
- Background: PubMed 27810851Garcia-Ptacek S, Modeer IN, Kareholt I, Fereshtehnejad SM, Farahmand B, Religa D, Eriksdotter M. Differences in diagnostic process, treatment and social Support for Alzheimer's dementia between primary and specialist care: resultss from the Swedish Dementia Registry. Age Ageing. 2017 Mar 1;46(2):314-319. doi: 10.1093/ageing/afw189.
- Background: PubMed 28550260Cermakova P, Nelson M, Secnik J, Garcia-Ptacek S, Johnell K, Fastbom J, Kilander L, Winblad B, Eriksdotter M, Religa D. Living Alone with Alzheimer's Disease: Data from SveDem, the Swedish Dementia Registry. J Alzheimers Dis. 2017;58(4):1265-1272. doi: 10.3233/JAD-170102.
- Background: PubMed 27801938Garcia-Ptacek S, Kareholt I, Cermakova P, Rizzuto D, Religa D, Eriksdotter M. Causes of Death According to Death Certificates in Individuals with Dementia: A Cohort from the Swedish Dementia Registry. J Am Geriatr Soc. 2016 Nov;64(11):e137-e142. doi: 10.1111/jgs.14421. Epub 2016 Nov 1.
- Results publication: PubMed 39994788Mo M, Abzhandadze T, Hoang MT, Sacuiu S, Jurado PG, Pereira JB, Naia L, Kele J, Maioli S, Xu H, Eriksdotter M, Garcia-Ptacek S. Antidepressant use and cognitive decline in patients with dementia: a national cohort study. BMC Med. 2025 Feb 25;23(1):82. doi: 10.1186/s12916-025-03851-3.
- Results publication: PubMed 39772858Grau-Jurado P, Mostafaei S, Xu H, Mo M, Petek B, Kalar I, Naia L, Kele J, Maioli S, Pereira JB, Eriksdotter M, Chatterjee S, Garcia-Ptacek S. Medications and cognitive decline in Alzheimer's disease: Cohort cluster analysis of 15,428 patients. J Alzheimers Dis. 2025 Feb;103(3):931-940. doi: 10.1177/13872877241307870. Epub 2025 Jan 8.
- Results publication: PubMed 38115091Petek B, Habel H, Xu H, Villa-Lopez M, Kalar I, Hoang MT, Maioli S, Pereira JB, Mostafaei S, Winblad B, Gregoric Kramberger M, Eriksdotter M, Garcia-Ptacek S. Statins and cognitive decline in patients with Alzheimer's and mixed dementia: a longitudinal registry-based cohort study. Alzheimers Res Ther. 2023 Dec 20;15(1):220. doi: 10.1186/s13195-023-01360-0.
- Related InfoLink provided by the sponsor.
- 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.
Sara Garcia-Ptacek, MD,PhD principal investigator
Karolinska Institutet
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 Dementia Disorders, 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 1 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?
On the ClinicalTrials.gov record for NCT05817188, which also lists 9 linked publications.
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.