NCT02572219

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for phase_3 hypertension

Timeline
Completed

Started Nov 2015

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 6, 2015

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 8, 2015

Completed
24 days until next milestone

Study Start

First participant enrolled

November 1, 2015

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2016

Completed
Last Updated

March 14, 2017

Status Verified

March 1, 2017

Enrollment Period

1 year

First QC Date

October 6, 2015

Last Update Submit

March 13, 2017

Conditions

Hypertension

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

Nutraceutical

ACTIVE COMPARATOR

Treated with nutraceutical compound

Dietary Supplement: Nutraceutical compound

Placebo

PLACEBO COMPARATOR

Treated with placebo

Dietary Supplement: Placebo

Interventions

Nutraceutical compoundDIETARY_SUPPLEMENT
Nutraceutical
PlaceboDIETARY_SUPPLEMENT
Placebo

Eligibility Criteria

Age40 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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).

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

IRCCS Neuromed

Pozzilli, (is), 86077, Italy

Location

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
prof. Giuseppe Lembo

Study Record Dates

First Submitted

October 6, 2015

First Posted

October 8, 2015

Study Start

November 1, 2015

Primary Completion

November 1, 2016

Study Completion

November 1, 2016

Last Updated

March 14, 2017

Record last verified: 2017-03

Locations

IT(1)