Affiliated to the General Scheme Clinical Trial
— EXMEDEMOfficial title:
Sample Analysis Generalist Beneficiaries of Health Insurance From 2004 to 2014
| Verified date | August 2019 |
| Source | University Hospital, Montpellier |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
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.
| Status | Active, not recruiting |
| Enrollment | 120000 |
| Est. completion date | December 2019 |
| Est. primary completion date | December 2019 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 60 Years to 85 Years |
| Eligibility |
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 |
| Country | Name | City | State |
|---|---|---|---|
| France | UHMontpellier | Montpellier |
| Lead Sponsor | Collaborator |
|---|---|
| University Hospital, Montpellier |
France,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | drug exposures | drug exposures (grouped by therapeutic class and / or analyzed molecule by molecule) in 2004-2005-2006 | 1 year | |
| Secondary | dementia occurred | dementia occurred in 2011, 2012, 2013 or 2014 | 1 year |