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Validation of New Tools for the Assessment of Cognitive Functions and Connectivity Network 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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02310217
Recruitment Status : Recruiting
First Posted : December 8, 2014
Last Update Posted : June 17, 2019
Sponsor:
Information provided by (Responsible Party):
Giuseppe Lembo, Neuromed IRCCS

Brief Summary:

The relationship among hypertension, aging and cognitive decline is complex and not completely understood. Purpose of this project will be evaluating early markers of cognitive deterioration in patients with arterial hypertension. In particular, this cross-sectional observational study will be articulated in three phases:

  1. Neuropsychological evaluation of general cognitive abilities
  2. Identification and measurement of specific biomarker levels
  3. Correlation among hypertension, cognitive abilities and biomarkers.

Condition or disease
Hypertension Cognitive Impairment

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Study Type : Observational
Estimated Enrollment : 160 participants
Observational Model: Other
Time Perspective: Cross-Sectional
Official Title: Validation of New Tools for the Assessment of Cognitive Functions and Connectivity Network in Hypertensive Patients
Study Start Date : February 2015
Estimated Primary Completion Date : September 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine


Group/Cohort
1
Hypertensive
2
Normotensive



Primary Outcome Measures :
  1. Cognitive abilities measured by validated neuropsychological test battery (Montreal Cognitive Assessment test, Verbal Fluency test,learning of couple words, Stroop test) [ Time Frame: 18 months ]


Information from the National Library of Medicine

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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
Sampling Method:   Probability Sample
Study Population
Patients will be selected from the Department of Angiocardioneurology and Translational Medicine of the IRCCS Neuromed, according to specific inclusion criteria. Approximatey 80 subjects per group, aged between 40 and 65 years, will be included in the study.
Criteria

Inclusion Criteria:

  • Males or females diagnosed with arterial hypertension between 40 and 65 years of age;
  • Written informed consent prior to enrollment in the study.

Exclusion Criteria:

  • Precedent acute myocardial infarction (AMI);
  • Previous stroke and/or transient ischemic attack (TIA);
  • Previous or concomitant neurologic or psychiatric pathologies;
  • Neurologic or psychiatric pharmacological therapy.

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): NCT02310217


Contacts
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Contact: Giuseppe Lembo, MD, PhD +39 0865.915225 lembo@neuromed.it

Locations
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Italy
IRCCS Neuromed Recruiting
Pozzilli, (is), Italy, 86077
Principal Investigator: Giuseppe Lembo, prof., MD, PhD         
Sub-Investigator: Giulio Selvetella, MD, PhD         
Sub-Investigator: Daniela Carnevale, PhD         
Sponsors and Collaborators
Neuromed IRCCS
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Responsible Party: Giuseppe Lembo, MD, PhD, Neuromed IRCCS
ClinicalTrials.gov Identifier: NCT02310217    
Other Study ID Numbers: LMB03
First Posted: December 8, 2014    Key Record Dates
Last Update Posted: June 17, 2019
Last Verified: June 2019
Keywords provided by Giuseppe Lembo, Neuromed IRCCS:
Hypertension
Cognitive impairment
Biomarkers
Additional relevant MeSH terms:
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Hypertension
Cognitive Dysfunction
Vascular Diseases
Cardiovascular Diseases
Cognition Disorders
Neurocognitive Disorders
Mental Disorders