Status:
COMPLETED
Impact of Controlling Vascular Risk Factors on the Progression of Alzheimer's Disease
Lead Sponsor:
University Hospital, Lille
Collaborating Sponsors:
Ministry of Health, France
Conditions:
Alzheimer's Disease
Cardiovascular Risk Factors
Eligibility:
All Genders
60+ years
Phase:
NA
Brief Summary
Three quarters of patients with Alzheimer's disease have at least one vascular risk factor (VRF). Vascular brain lesions are present in most Alzheimer's patients (especially older ones). This cerebrov...
Detailed Description
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 ...
Eligibility Criteria
Inclusion
- Inclusion criteria
- Subjects aged 60 or over
- Subjects with Alzheimer's disease, according to the NINCDS/ADRDA diagnostic criteria 71
- MMSE \> 18
- Subjects with at least one VRF (whether treated or not): arterial hypertension (defined as SBP/DBP ≥ 140/90 mmHg in at least three different consultations or, for ambulatory measurements, \> 130/80 mmHg with a Holter recorder or \> 135/85 mmHg with a self-measurement device), type 2 diabetes (defined as a glycaemia value over 1.26 g/l (7 mmol/l) after an 8-hour fast (confirmed on two occasions), dyslipidaemia (defined as an LDL cholesterol level \> 1.6 g/l or 1.3 or 1 g/l, depending on the patient's risk level)
- Subjects having agreed to participate in the study (provision of informed consent).
- Subjects accompanied by a person likely to provide information on the patient (during the visit or over the phone).
- Exclusion criteria
- Any other disease that might interfere with the evaluation of cognitive disorders.
- No formal education or a poor understanding of French (interfering with administration of the neuropsychological tests).
- Major physical problems likely to interfere with administration of the tests (poor eyesight, hearing, etc.).
- Non-Alzheimer's dementia (isolated vascular dementia, Lewy body dementia, frontotemporal dementia, etc.)
- Psychotropic drugs likely to modify the patient's non-stabilized cognitive state.
- Patients with a history of cardiovascular events can be included (randomization will be balanced in terms of this criterion).
- Participation in a therapeutic clinical trial during the study period.
Exclusion
Key Trial Info
Start Date :
March 15 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2022
Estimated Enrollment :
304 Patients enrolled
Trial Details
Trial ID
NCT01423396
Start Date
March 15 2010
End Date
May 1 2022
Last Update
May 24 2022
Active Locations (21)
Enter a location and click search to find clinical trials sorted by distance.
1
Chu Amiens Picardie
Amiens, France
2
CH ARRAS
Arras, France
3
Centre Hospitalier Bethune Beuvry
Béthune, France
4
CH Boulogne
Boulogne-sur-Mer, France