Medication Repurposing to Stop Cognitive Decline in Dementia

Alzheimer Dementia Clinical Trial

Official title:

Translational Identification of Medication Repurposing Candidates to Slow Cognitive Decline in Dementia

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05817188
• Other study ID #: 2022-01425
• Status: Active, not recruiting
• Start date: January 1, 2023
• Est. completion date: December 31, 2030

Study information

• Verified date: April 2023
• Source: Karolinska Institutet
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 100000
• Est. completion date: December 31, 2030
• Est. primary completion date: December 31, 2028
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years and older

Eligibility

Inclusion Criteria:

All patients with dementia registered in SveDem.

Exclusion Criteria:

Lack of Swedish personal identification number or coordination number.

Related Conditions & MeSH terms

• Alzheimer Dementia
• Alzheimer Disease
• Cognitive Dysfunction
• Dementia
• Dementia Disorders

Intervention

Other:
• No intervention
No intervention was applied

Locations

Country	Name	City	State
Sweden	Karolinska Institutet	Stockholm

Sponsors (3)

Lead Sponsor	Collaborator
Karolinska Institutet	KTH Royal Institute of Technology, Region Stockholm

Country where clinical trial is conducted

Sweden, 

References & Publications (6)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Rate of nursing home placement	Data will be obtained from the social services registry.	Through study completion, at least 1 year
Secondary	Mortality	Data about date and cause(s) of death will be collected from The Cause of Death Register.	Through study completion, at least 1 year

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