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Effects of a Nutraceutical Preparation on Cognitive Impairment in Hypertensive Patients

Primary Purpose

Hypertension

Status
Completed
Phase
Phase 3
Locations
Italy
Study Type
Interventional
Intervention
Nutraceutical compound
Placebo
Sponsored by
Neuromed IRCCS
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypertension

Eligibility Criteria

40 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • IRCCS Neuromed

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Nutraceutical

Placebo

Arm Description

Treated with nutraceutical compound

Treated with placebo

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
October 6, 2015
Last Updated
March 13, 2017
Sponsor
Neuromed IRCCS
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1. Study Identification

Unique Protocol Identification Number
NCT02572219
Brief Title
Effects of a Nutraceutical Preparation on Cognitive Impairment in Hypertensive Patients
Official Title
Effects of a Nutraceutical Preparation on Cognitive Impairment in Hypertensive Patients
Study Type
Interventional

2. Study Status

Record Verification Date
March 2017
Overall Recruitment Status
Completed
Study Start Date
November 2015 (Actual)
Primary Completion Date
November 2016 (Actual)
Study Completion Date
November 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Neuromed IRCCS

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertension

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
12 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Nutraceutical
Arm Type
Active Comparator
Arm Description
Treated with nutraceutical compound
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Treated with placebo
Intervention Type
Dietary Supplement
Intervention Name(s)
Nutraceutical compound
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
Cognitive function assessed by neuropsychological tests
Description
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.
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
IRCCS Neuromed
City
Pozzilli
State/Province
(is)
ZIP/Postal Code
86077
Country
Italy

12. IPD Sharing Statement

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Effects of a Nutraceutical Preparation on Cognitive Impairment in Hypertensive Patients

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