NCT05817188

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2023

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2023

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

April 4, 2023

Completed
14 days until next milestone

First Posted

Study publicly available on registry

April 18, 2023

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2025

Completed
Last Updated

May 2, 2025

Status Verified

April 1, 2023

Enrollment Period

2.2 years

First QC Date

April 4, 2023

Last Update Submit

April 29, 2025

Conditions

Keywords

medicationrepurposingcognitive declinedementiaMini-Mental State Examination

Outcome Measures

Primary Outcomes (1)

  • 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.

    Through study completion, at least 1 year

Secondary Outcomes (2)

  • Rate of nursing home placement

    Through study completion, at least 1 year

  • Mortality

    Through study completion, at least 1 year

Study Arms (1)

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.

Other: No intervention

Interventions

No intervention was applied

Dementia patients

Eligibility Criteria

Age40 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

  • All patients with dementia registered in SveDem.

You may not qualify if:

  • Lack of Swedish personal identification number or coordination number.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Karolinska Institutet

Stockholm, 17177, Sweden

Location

Related Publications (9)

  • 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.

    PMID: 25695768BACKGROUND
  • Garcia-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.

    PMID: 24721339BACKGROUND
  • Roheger 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.

    PMID: 29656469BACKGROUND
  • Garcia-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.

    PMID: 27810851BACKGROUND
  • Cermakova 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.

    PMID: 28550260BACKGROUND
  • Garcia-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.

    PMID: 27801938BACKGROUND
  • Mo 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.

    PMID: 39994788BACKGROUND
  • Grau-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.

    PMID: 39772858BACKGROUND
  • Petek 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.

    PMID: 38115091BACKGROUND

Related Links

MeSH Terms

Conditions

Alzheimer DiseaseCognitive DysfunctionDementia

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesTauopathiesNeurodegenerative DiseasesNeurocognitive DisordersMental DisordersCognition Disorders

Study Officials

  • Sara Garcia-Ptacek, MD,PhD

    Karolinska Institutet

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor/Docent (title formerly translated Assoc Prof)

Study Record Dates

First Submitted

April 4, 2023

First Posted

April 18, 2023

Study Start

January 1, 2023

Primary Completion

March 1, 2025

Study Completion

March 1, 2025

Last Updated

May 2, 2025

Record last verified: 2023-04

Data Sharing

IPD Sharing
Will not share

Locations