Impact of Controlling Vascular Risk Factors on the Progression of Alzheimer's Disease (COVARAD)
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|ClinicalTrials.gov Identifier: NCT01423396|
Recruitment Status : Completed
First Posted : August 25, 2011
Last Update Posted : May 24, 2022
|Condition or disease||Intervention/treatment||Phase|
|Alzheimer's Disease Cardiovascular Risk Factors||Other: optimal care of VRF Other: standard care||Not Applicable|
It is not currently known whether the optimum treatment of VRFs influences the progression and prognosis of Alzheimer's disease. Our starting hypothesis is that VRF control in Alzheimer's patients is associated with slower cognitive decline, less intense loss of personnel independence and fewer adverse events over the course of the disease (cardiovascular or cerebrovascular events, behavioural disorders, caregiver burden, hospitalization and death).
COVARAD study is a randomized, controlled, multicentre study comparing 2 VRF care strategies in mild-to-moderate (MMSE > 18) Alzheimer's disease patients with at least one VRF. The objective of this work is to evaluate the effect of "optimal" care strategy, in strict compliance with the French HAS guidelines concerning targets for blood pressure, glycaemia and blood lipid levels, on the cognitive function in mild-to-moderate Alzheimer's patients (MMSE score > 18), in comparison with a control group (i.e. receiving standard care from a primary care physician). The study test the hypothesis whereby "optimal" care of the 3 main modifiable VRFs is associated with slower cognitive decline in Alzheimer's disease patients (evaluated on the ADAS-cog score), when compared with standard care and to compare the MMSE, MoCA and VADAS-cog scores, mood and behaviour (MADRS and NPI), loss of independence (ADCS-ADL), the occurrence of cardiovascular or cerebrovascular events, the number and length of hospitalisations, caregiver burden (on the Zarit scale), institutionalization and survival in the two groups (i.e. depending whether VRFs are managed optimally or not).
This study could influence clinical practice. If VRF control does have an influence on the progression of Alzheimer's disease, an information campaign could modify practice and have a significant impact on public health.
An independent Data and Safety Monitoring Board will be set up to monitor the diabetic patients, in view of the risks related to "optimal" care (ACCOR and ADVANCE studies). Nevertheless, the risk of adverse events will be limited by raising the threshold value for glycated haemoglobin to 8%.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||304 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Impact of Controlling Vascular Risk Factors on the Progression of Alzheimer's Disease|
|Actual Study Start Date :||March 15, 2010|
|Actual Primary Completion Date :||May 2022|
|Actual Study Completion Date :||May 2022|
Follow up with city doctor with recommendation HAS French guidelines
Other: standard care
AD patients will be followed with the city doctor and the letter t will be send for remember French HAS guidelines
Experimental: optimal care of VRF
Monitoring according to the strict recommendations of the HAS French guidelines
Other: optimal care of VRF
VRF of AD patients will be treated optimally in strict compliance with the French HAS guidelines concerning targets for blood pressure, glycaemia and blood lipid levels, in accordance with standardized therapeutic regimens.
- ADAS-Cog [ Time Frame: 18 months ]
- MMSE [ Time Frame: 18 months ]
- MoCA [ Time Frame: 18 months ]
- VADAS-Cog [ Time Frame: 18 months ]
- Trail Making Test [ Time Frame: 18 months ]
- ADL-ADCS [ Time Frame: 18 months ]
- IADL [ Time Frame: 18 months ]
- MADRS [ Time Frame: 18 months ]
- NPI [ Time Frame: 18 months ]
- Zarit Inventory of Burden [ Time Frame: 18 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01423396
|Study Director:||Florence PASQUIER, MD||Univ Lille Nord de France, clinique neurologique, Centre Mémoire de Ressources et de Recherche - CHRU Lille|
|Principal Investigator:||Marie-Anne MACKOWIAK, MD||Univ Lille Nord de France, clinique neurologique, Centre Mémoire de Ressources et de Recherche - CHRU Lille|
|Principal Investigator:||Didier HANNEQUIN, MD||CHU Rouen|
|Principal Investigator:||Olivier GODEFROY, MD||CHU Amiens|
|Principal Investigator:||Muriel RAINFRAY, MD||CHU Bordeaux|