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NCT Number: NCT02572219

Effects of a Nutraceutical Preparation on Cognitive Impairment in Hypertensive Patients

Aim of this randomized, double-blind clinical study is to evaluate the efficacy of a nutraceutical preparation on early markers of cognitive impairment, in patients affected by arterial hypertension.

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Key information

Conditions

Hypertension Cardiovascular Diseases Vascular Diseases

Age range

40 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

IRCCS Neuromed

Pozzilli, (is), 86077, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Written informed consent;
  • Males or females between 40 and 65 years of age;
  • Hypertensive patients classified according to their SBP (Systolic Blood Pressure) and DBP (Diastolic Blood Pressure) values. Included patients will be those with stage 1 hypertension (SBP 140-159 mmHg; DBP 90-99 mmHg) and with stage 2 hypertension (SBP 160-179 mmHg; DBP 100-109 mmHg).

Exclusion criteria

  • Previous acute myocardial infarction (AMI);
  • Previous stroke and/or transient ischemic attack (TIA);
  • Diabetes mellitus;
  • History of atrial fibrillation or other severe arrhythmias;
  • Severe cardiovascular diseases;
  • Renal pathologies (creatinine > 1.4 mg/dL);
  • Preexisting psychiatric pathologies;
  • Neurodegenerative diseases, such as multiple sclerosis, lateral amyotrophic sclerosis, Parkinson, Alzheimer, neuromuscular pathologies, epilepsy;
  • Diagnosis of dementia;
  • Depression;
  • Long-term regular use of anxiolytics drugs, antidepressant drugs, antipsychotic drugs, hypnoinducing drugs, cognitive stimulators.

Treatment and study plan

Nutraceutical compound

Dietary Supplement

Placebo

Dietary Supplement

Primary outcomes

  1. Cognitive function assessed by neuropsychological tests

    Time frame: 6 months

    Patients will be subjected to Montreal Cognitive Assessment (MoCA), Verbal fluency test, Word coupling test, Stroop test, and Instrumental Activities of Daily Living - IADL test. Assessments of cognitive functions will be performed by using unique score measurements defined in Units on a Scale.

Sponsors and collaborators

Lead sponsor

Neuromed IRCCS

Other

Registry information

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Oct 8, 2015
Registry last updated
Mar 14, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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