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New treatment option for Small Vessel Cerebrovascular Disease
Official title Targeting Neurovascular Coupling in Cognitive Decline Via Nitrate-Based Supplementation
ClinicalTrials.gov ID: NCT07329647
What this study is testing
- What it's testing
- Diet is established among the most relevant adjustable variables of human health in modern societies. The recognition by the World Health Organization of cognitive impairment and dementia associated with aging as one of the major public health challenges of our time, highlights the imperative need for a more comprehensive understanding of how different aspects of lifestyle, in particular diet, affect neural function and consequent cognitive performance throughout lifespan.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Formal diagnosis of cerebral small vessel disease (grades 1 to 3 in the Age-Related White Matter Changes Scale as assessed by Computerized Tomography...
- Subject has capacity and is capable of giving written informed consent;
- Subject is able to read, comprehend and record information written in Portuguese.
You likely can't join if
- Vascular diseases other than cerebral Small Vessel Disease (cSVD);
- Stroke event less than 6 months ago;
- Unsuitable for MRI scanning because of presence of any standard MRI contraindication (e.g presence of a cardiac pacemaker, other medical implants or...
- Needle phobia;
- Inability or intolerance to dietary polyphenol adjustment;
- Current smoker;
See the full eligibility criteria
- Formal diagnosis of cerebral small vessel disease (grades 1 to 3 in the Age-Related White Matter Changes Scale as assessed by Computerized Tomography or Magnetic Ressonance Imaging - MRI) and patients at high risk for...
- Subject has capacity and is capable of giving written informed consent;
- Subject is able to read, comprehend and record information written in Portuguese.
- Vascular diseases other than cerebral Small Vessel Disease (cSVD);
- Stroke event less than 6 months ago;
- Unsuitable for MRI scanning because of presence of any standard MRI contraindication (e.g presence of a cardiac pacemaker, other medical implants or devices, or the presence of ferromagnetic metal foreign bodies);
- Needle phobia;
- Inability or intolerance to dietary polyphenol adjustment;
- Current smoker;
- Alcohol abuse, drug abuse or use of drugs affecting cognitive assessment, such as sedatives, hypnotics, nootropic drugs, cholinergic drugs;
- Use of medications that may be contraindicated or interact with the high nitrate diet, such as nitroglycerin or nitrate preparations used for angina, or phosphodiesterase type 5 (PDE5) inhibitors, including sildenafil...
- Patients previously diagnosed with dementia;
- Presence of congenital mental retardation and severe neurological and psychiatric diseases;
- Illiterate or severe visual or hearing impairment that may prevent patients from cooperating with cognitive assessment;
- Relevant depression or other unrelated serious mental illness;
- Severe cardiac, pulmonary, renal or hepatic insufficiency;
- Patients who have participated in other treatment clinical studies within the last 3 months, or are participating in other treatment clinical studies.
The study team makes the final eligibility decision.
Where it's taking place
- Coimbra, Portugal
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, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Coimbra, Portugal. 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.