- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT02823938
DRUG EXPOSURE AND RISK OF DEMENTIA (EXMEDEM)
Sample Analysis Generalist Beneficiaries of Health Insurance From 2004 to 2014
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.
Přehled studie
Postavení
Podmínky
Intervence / Léčba
Detailní popis
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.
Typ studie
Zápis (Očekávaný)
Kontakty a umístění
Studijní místa
-
-
-
Montpellier, Francie, 34295
- UHMontpellier
-
-
Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Metoda odběru vzorků
Studijní populace
Popis
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
Studijní plán
Jak je studie koncipována?
Detaily designu
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
---|---|---|
drug exposures
Časové okno: 1 year
|
drug exposures (grouped by therapeutic class and / or analyzed molecule by molecule) in 2004-2005-2006
|
1 year
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
---|---|---|
dementia occurred
Časové okno: 1 year
|
dementia occurred in 2011, 2012, 2013 or 2014
|
1 year
|
Spolupracovníci a vyšetřovatelé
Sponzor
Vyšetřovatelé
- Ředitel studie: Thibault MURA, UH Montpellier
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Aktuální)
Primární dokončení (Očekávaný)
Dokončení studie (Očekávaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Odhad)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Další identifikační čísla studie
- 9641
Plán pro data jednotlivých účastníků (IPD)
Plánujete sdílet data jednotlivých účastníků (IPD)?
Popis plánu IPD
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