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DRUG EXPOSURE AND RISK OF DEMENTIA

Sample Analysis Generalist Beneficiaries of Health Insurance From 2004 to 2014

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02823938
Acronym
EXMEDEM
Enrollment
120000
Registered
2016-07-06
Start date
2016-04-01
Completion date
2019-12-31
Last updated
2019-09-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Affiliated to the General Scheme

Brief summary

In France, a person consumes an average of 48 boxes of medicines per year (ANSM 2012). Among these substances, some, not prescribed in an indication related to cognitive function, however, will influence thereon. Several drug candidates with potential preventive effects have already been explored with little success (statins, antihypertensives, NSAIDs, aspirin, steroid hormones). Other studies have suggested the existence of deleterious cognitive effects of certain substances (benzodiazepines, anticholinergics, anti-cancer chemotherapy). However, only the effects of a limited number of drugs were analyzed, and most drugs have not been specific study in epidemiology. The study of this research theme has often been restricted by the limited size of the cohort of staff, not allowing the study of sometimes rare drug exposures, and poverty of the information collected on drug exposures. Thus, most studies focuses on families of molecules among the most prescribed. In addition, we now know that the pathophysiological process underlying Alzheimer's disease (representing 2/3 of dementia), actually begins more than 10 years before the diagnosis of dementia. It is therefore essential to have a setback of several years between drug exposure and diagnosis of dementia to assess their role in the genesis and evolution of the disease. The Generalist Sample Beneficiaries (EGB) is a database containing data of health insurance and those of medicalization program of information systems (PMSI) for a sample of 550 000 subjects enrolled in the general scheme of the insurance since 2004 and followed for a period of 20 years.

Detailed description

In France, a person consumes an average of 48 boxes of medicines per year (ANSM 2012). Among these substances, some, not prescribed in an indication related to cognitive function, however, will influence thereon. Several drug candidates with potential preventive effects have already been explored with little success (statins, antihypertensives, NSAIDs, aspirin, steroid hormones). Other studies have suggested the existence of deleterious cognitive effects of certain substances (benzodiazepines, anticholinergics, anti-cancer chemotherapy). However, only the effects of a limited number of drugs were analyzed, and most drugs have not been specific study in epidemiology. The study of this research theme has often been restricted by the limited size of the cohort of staff, not allowing the study of sometimes rare drug exposures, and poverty of the information collected on drug exposures. Thus, most studies focuses on families of molecules among the most prescribed. In addition, we now know that the pathophysiological process underlying Alzheimer's disease (representing 2/3 of dementia), actually begins more than 10 years before the diagnosis of dementia. It is therefore essential to have a setback of several years between drug exposure and diagnosis of dementia to assess their role in the genesis and evolution of the disease. The Generalist Sample Beneficiaries (EGB) is a database containing data of health insurance and those of medicalization program of information systems (PMSI) for a sample of 550 000 subjects enrolled in the general scheme of the insurance since 2004 and followed for a period of 20 years.

Interventions

OTHERexisting database on data collection.

This is an observational study on an existing database.

Sponsors

University Hospital, Montpellier
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
60 Years to 85 Years
Healthy volunteers
No

Inclusion criteria

* from over 60 and under 85 years in 2011, * Affiliated to the general scheme and present in the base of the EGB since 2004 * Not diagnosed as demented before 2011

Exclusion criteria

* NA

Design outcomes

Primary

MeasureTime frameDescription
drug exposures1 yeardrug exposures (grouped by therapeutic class and / or analyzed molecule by molecule) in 2004-2005-2006

Secondary

MeasureTime frameDescription
dementia occurred1 yeardementia occurred in 2011, 2012, 2013 or 2014

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026