Effects of a Nutraceutical Preparation on Cognitive Impairment in Hypertensive Patients

Hypertension Clinical Trial

Official title:

Effects of a Nutraceutical Preparation on Cognitive Impairment in Hypertensive Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02572219
• Other study ID #: LMB04
• Status: Completed
• Phase: Phase 3
• First received: October 6, 2015
• Last updated: March 13, 2017
• Start date: November 2015
• Est. completion date: November 2016

Study information

• Verified date: March 2017
• Source: Neuromed IRCCS
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: November 2016
• Est. primary completion date: November 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cognition Disorders
• Hypertension

Intervention

Dietary Supplement:
• Nutraceutical compound

• Placebo

Locations

Country	Name	City	State
Italy	IRCCS Neuromed	Pozzilli	(is)

Sponsors (1)

Lead Sponsor	Collaborator
Neuromed IRCCS

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cognitive function assessed by neuropsychological tests	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.	6 months