Effects of a Nutraceutical Preparation on Cognitive Impairment in Hypertensive Patients

Phase 3

Completed

• Conditions: Hypertension
• Interventions: Dietary Supplement: Nutraceutical compound; Dietary Supplement: Placebo

• Registration Number: NCT02572219
• Lead Sponsor: Neuromed IRCCS

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-10-06
• Study First Submitted QC: 2015-10-07
• Study First Posted: 2015-10-08
• Study Start: 2015-11
• Primary Completion: 2016-11
• Study Completion: 2016-11
• Status Verified: 2017-03
• Last Update Submitted: 2017-03-13
• Last Update Posted: 2017-03-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Nutraceutical	Nutraceutical compound	Treated with nutraceutical compound
Placebo	Placebo	Treated with placebo

Primary Outcome Measures

Name	Time	Method
Cognitive function assessed by neuropsychological tests	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.

Trial Locations

Locations (1)

IRCCS Neuromed; 🇮🇹 Pozzilli, (is), Italy