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New treatment option for Cerebrovascular Disorders
Official title Blood Pressure Reduction to Limit the Evolution of Vascular Brain Lesions in Elderly Individuals
ClinicalTrials.gov ID: NCT02472028
What this study is testing
- What it's testing
- 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.
- Phase 4: studies an already-approved treatment
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 60 to 88
You may be able to join if
- 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...
- Hypertension defined by a Systolic Blood Pressure (SBP) and / or a Diastolic Blood Pressure (DBP) ≥ 140/90 mmHg, treated or not
You likely can't join if
- 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...
- 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;
See the full eligibility 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
- 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...
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Bordeaux, Pellegrin Hospital Group, France
- Paris, France
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 60 years to 88 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Bordeaux, Pellegrin Hospital Group, France; Paris, France. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.