Cerebrovascular Disorders Clinical Trial
— LEOPOLDOfficial title:
LEukoaraiosis and blOod Pressure Reduction in OLD People
The purpose of the study is to test the hypothesis of slowing the progression of White Matter Lesions (WML) by lowering blood pressure (BP) in patients with cognitive complaints and a moderate to high grade of WML on brain MRI.
Status | Recruiting |
Enrollment | 820 |
Est. completion date | September 11, 2028 |
Est. primary completion date | September 11, 2028 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 60 Years to 88 Years |
Eligibility | Inclusion Criteria: - 60 to 88 years old patients; - Patient with cognitive complaint with MMSE = 20performed within 6 months prior to enrollment (with or without dementia) - Patient with a socio-educational level = 3 - Presence of hyperintensities of moderate to high grade on the last MRI or old scan (grades C and D on the modified Scheltens scale, grades 2/3 Fazekas). - Hypertension defined by a Systolic Blood Pressure (SBP) and / or a Diastolic Blood Pressure (DBP) = 140/90 mmHg, treated or not - Affiliation to a social security system - Informed consent given, signed consent Exclusion Criteria: - Presence of severe orthostatic hypotension defined as a decrease of 30 mmHg in SBP standing within 3 minutes - Contraindication to MRI (presence of ferromagnetic foreign body (especially some intracranial clips, some heart valves, intraocular foreign bodies, metal prosthesis), subject carrying pacemaker, claustrophobic participants) - Severe diseases associated with a life expectancy of less than 3 months; - Major physical impairments that can interfere with the feasibility of the tests (sight, hearing ...) - Presence of another dementia different than Alzheimer's disease vascular dementia or mixed dementia, - Persons under guardianship; - Secondary hypertension: renovascular hypertension, primary aldosteronism, pheochromocytoma ...; - Patient already receiving 4 or more antihypertensive drugs at maximum dosage - Patient participating in another clinical research study on drug requiring exclusion period - severe renal impairment |
Country | Name | City | State |
---|---|---|---|
France | Memory for Research and Resources Center / Neuroscience pole | Bordeaux | Pellegrin Hospital Group |
France | Memory Resources Centre and South of Ile de France Search - Broca Hospital | Paris |
Lead Sponsor | Collaborator |
---|---|
Assistance Publique - Hôpitaux de Paris |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The main criterion is based on the quantitative assessment of White Matter Lesions (WML) volumes at the beginning and at the end of the study for each patient and each arm of the trial. The WML volume from the final MRI is compared to that of the initial | 36 months + 6 months max | ||
Secondary | Imaging criteria : changes in the number of large or confluent WML | 36 months+ 6 months max | ||
Secondary | Imaging criteria : changes in the volume of WML depending on their location (periventricular and deep white matter) | 36 months+ 6 months max | ||
Secondary | Imaging criteria : changes in the number of silent infarctus | 36 months+ 6 months max | ||
Secondary | Imaging criteria : changes in the number of microbleeds | 36 months+ 6 months max | ||
Secondary | Imaging criteria : evolution of brain volumes (gray matter, white matter, CSF, and regional volumes including hippocampus) | 36 months+ 6 months max | ||
Secondary | Clinical criteria: clinical criteria (changes in neuropsychological tests | 36 months | ||
Secondary | Clinical criteria: changes inwalking speed | 36 months | ||
Secondary | Clinical criteria: number of incident cases of dementia | 36 months | ||
Secondary | Number of incident cases of vascular events validated by an expert committee | 36 months | ||
Secondary | Clinical criteria: total mortality by cause | 36 months+ 6 months max |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT03239847 -
Cost Effectiveness of the EndoPhys Pressure Sensing Access System vs. Radial A-line for Intra-operative Blood Pressure Monitoring
|
N/A | |
Recruiting |
NCT03544801 -
Renji Cerebral Small Vessel Disease Corhort Study
|
||
Recruiting |
NCT06010823 -
Safety and Efficacy Evaluation of the Robotic Enhanced Error Training of Upper Limb Function in Post-stroke and Post TBI Participants
|
N/A | |
Withdrawn |
NCT04991038 -
Clinical Investigation to Compare Safety and Efficacy of DAISE and Stent Retrievers for Thrombectomy In Acute Ischemic Stroke Patients
|
N/A | |
Completed |
NCT01915368 -
Determining Optimal Post-Stroke Exercise (DOSE)
|
N/A | |
Active, not recruiting |
NCT01555411 -
Akershus Cardiac Examination (ACE) 1950 Study
|
||
Completed |
NCT01304576 -
Orientation Agnosia: Clinical and Anatomical Study
|
N/A | |
Completed |
NCT00049920 -
The ARIC MRI Study
|
N/A | |
Completed |
NCT00059293 -
Transcranial Doppler (TCD) Ultrasound of Subjects Enrolled in BABY HUG - Ancillary to BABY HUG
|
||
Completed |
NCT00049894 -
Predictors of Recurrent Stroke in the PROGRESS Study
|
N/A | |
Completed |
NCT00005562 -
Coronary Artery Calcium, Exercise Tests, and CHD Outcome
|
N/A | |
Completed |
NCT00005395 -
Honolulu Heart Program-Study of Stroke and Dementia
|
N/A | |
Completed |
NCT00000479 -
Women's Health Study (WHS): A Randomized Trial of Low-dose Aspirin and Vitamin E in the Primary Prevention of Cardiovascular Disease and Cancer
|
Phase 3 | |
Completed |
NCT00005140 -
Epidemiology of Cardiovascular and Non-Cardiovascular Risk In Chicago
|
N/A | |
Enrolling by invitation |
NCT00005485 -
The Jackson Heart Study of Cardiovascular Disease Among African Americans
|
||
Recruiting |
NCT06275113 -
BRING-UP Prevention
|
||
Completed |
NCT02702635 -
Measuring Blood Flow Characteristics Using Dynamic Contrast Enhanced Magnetic Resonance Imaging
|
N/A | |
Recruiting |
NCT04336852 -
Development of a Clinically-relevant Test for Assessment of Cerebral Vascular Function
|
N/A | |
Not yet recruiting |
NCT05892510 -
Post-thrombectomy Intra-arterial Tenecteplase for Acute manaGement of Non-retrievable Thrombus and No-reflow in Emergent Stroke
|
Phase 2/Phase 3 | |
Completed |
NCT03994822 -
pRESET for Occlusive Stroke Treatment
|
N/A |