DRUG EXPOSURE AND RISK OF DEMENTIA
- Conditions
- Affiliated to the General Scheme
- Registration Number
- NCT02823938
- Lead Sponsor
- University Hospital, Montpellier
- 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 120000
- 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
- NA
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method drug exposures 1 year drug exposures (grouped by therapeutic class and / or analyzed molecule by molecule) in 2004-2005-2006
- Secondary Outcome Measures
Name Time Method dementia occurred 1 year dementia occurred in 2011, 2012, 2013 or 2014
Trial Locations
- Locations (1)
UHMontpellier
🇫🇷Montpellier, France