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Effects of a Nutraceutical Preparation on Cognitive Impairment in Hypertensive Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02572219
Recruitment Status : Completed
First Posted : October 8, 2015
Last Update Posted : March 14, 2017
Sponsor:
Information provided by (Responsible Party):
Giuseppe Lembo, 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.

Condition or disease Intervention/treatment Phase
Hypertension Dietary Supplement: Nutraceutical compound Dietary Supplement: Placebo Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effects of a Nutraceutical Preparation on Cognitive Impairment in Hypertensive Patients
Actual Study Start Date : November 2015
Actual Primary Completion Date : November 2016
Actual Study Completion Date : November 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Nutraceutical
Treated with nutraceutical compound
Dietary Supplement: Nutraceutical compound
Placebo Comparator: Placebo
Treated with placebo
Dietary Supplement: Placebo



Primary Outcome Measures :
  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.



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Ages Eligible for Study:   40 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02572219


Locations
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Italy
IRCCS Neuromed
Pozzilli, (is), Italy, 86077
Sponsors and Collaborators
Neuromed IRCCS
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Responsible Party: Giuseppe Lembo, prof. Giuseppe Lembo, Neuromed IRCCS
ClinicalTrials.gov Identifier: NCT02572219    
Other Study ID Numbers: LMB04
First Posted: October 8, 2015    Key Record Dates
Last Update Posted: March 14, 2017
Last Verified: March 2017
Additional relevant MeSH terms:
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Cognitive Dysfunction
Cognition Disorders
Neurocognitive Disorders
Mental Disorders