Perspective Memory and Executive Functions in HIV+ Patients ((3514))

Influence of Hot and Cold Cognition on Prospective Memory in HIV+ Patients

The primary goal of this observational study is to evaluate prospective memory in HIV+ patients compared to healthy subjects. The secondary goal is to examine the relationship between prospective memory and Hot Cognition (mechanical cognitive abilities) and Cold Cognition (cognitive abilities supported by emotion and social perception). The main questions it aims to answer are:

• Do HIV+ patients have more impaired prospective memory than healthy subjects?
• Is there a greater influence of Hot Cognition on prospective memory than Cold Cognition? Participants will undergo a battery of neuropsychological tests: Memory for Intentions Screening Test (MIST), Montreal Cognitive Assessment (MOCA), Interpersonal Reactivity Index and Modified Five Point Test.

Study Overview

• Status: Recruiting
• Conditions: HIV Infections
• Intervention / Treatment: Other: Neuropsychological testing

• Study Type: Observational
• Enrollment (Anticipated): 100

Contacts and Locations

Study Locations

• Italy
  • Roma, Italy, 00168
    • Recruiting
    • Fondazione Policlinico Universitario Agostino Gemelli IRCCS
    • Contact: Valentina Delle Donne; Phone Number: 0630155366; Email: valentina.delledonne1@unicatt.it

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

We expect the population with HIV and the healthy population compared by age (between 40 and 60 years old for the majority) and schooling (majority high school graduates). We expect a virologically suppressed HIV population with good adherence to antiretroviral therapy and deficits in prospective memory compared with the healthy population.

Description

Inclusion Criteria HIV+:

• consent to participate in the study
• diagnosis of HIV
• Current antiretroviral therapy
• age >18 years
• native Italian speaker

Exclusion Criteria HIV+:

• age <18 years
• presence of major psychiatric disorders within the past 6 months
• additional neurological conditions that may impair the performance of the tests (Alzheimer's disease, Outcomes of head-brain trauma, cerebrovascular episodes)
• Alcohol and drug addiction within the past 6 months
• Additional medical conditions that may impair neurocognitive profile and functional abilities (cerebrovascular damage, cardiac problems with functional impairment, severe liver disease)

Inclusion Criteria HIV- :

• consent to participate in the study
• Absence of HIV infection (HIV-RNA negative)
• age >18 years
• native speaker of Italian

Exclusion Criteria HIV+ :

• age <18 years
• presence of major psychiatric disorders within the past 6 months
• additional neurological conditions that may impair the performance of the tests (Alzheimer's disease, Outcomes of head-brain trauma, cerebrovascular episodes)
• Alcohol and drug addiction within the past 6 months
• additional medical conditions that may impair neurocognitive profile and functional abilities (cerebrovascular damage, heart problems with functional impairment, severe liver disease).

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Subjects with HIV infection; Both male and female subjects, over 18 years of age, on antiretroviral therapy, native speakers of Italian	Other: Neuropsychological testing; During the session the patient will be administered the Memory for Intentions Screening Test (MIST; Raskin et al., 2010) with the purpose of investigating prospective memory ability. Then during the same meeting the following tests will be offered to the patient: Montreal Cognitive Assessment (MOCA; Nasreddine. Translation Pirani et al 2006) investigating global cognitive performance; - Interpersonal Reactivity Index (IRI; Davis, 1980;1983- Italian version edited by Bonino et al, 1998) with the purpose of assessing cognitive and affective empathy (Hot cognition); Modified Five Point Test (Ruffi et al 1987) aimed at assessing figurative fluency (Cold cognition).
Healthy control subjects; Both male and female subjects, over the age of 18 years, no neurological or psychiatric conditions that would alter test performance, native speakers of Italian	Other: Neuropsychological testing; During the session the patient will be administered the Memory for Intentions Screening Test (MIST; Raskin et al., 2010) with the purpose of investigating prospective memory ability. Then during the same meeting the following tests will be offered to the patient: Montreal Cognitive Assessment (MOCA; Nasreddine. Translation Pirani et al 2006) investigating global cognitive performance; - Interpersonal Reactivity Index (IRI; Davis, 1980;1983- Italian version edited by Bonino et al, 1998) with the purpose of assessing cognitive and affective empathy (Hot cognition); Modified Five Point Test (Ruffi et al 1987) aimed at assessing figurative fluency (Cold cognition).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Prospective memory in HIV+ patients and healthy subjects	Prospective memory will be assessed through the following test: Memory for Intentions Screening Test (MIST).	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Influence of global cognitive performance on prospective memory	Montreal Cognitive Assessment (MOCA) investigating global cognitive performance.	1 year
Influence of hot cognition on perspective memory	Interpersonal Reactivity Index (IRI) with the purpose of assessing cognitive and affective empathy (Hot cognition).	1 year
Influence of cold cognition on perspective memory	Modified Five Point Test aimed at assessing figurative fluency (Cold cognition).	1 year

Collaborators and Investigators

• Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Study record dates

Study Major Dates

• Study Start (Actual): October 10, 2020
• Primary Completion (Anticipated): December 31, 2023
• Study Completion (Anticipated): December 31, 2023

Study Registration Dates

• First Submitted: January 30, 2023
• First Submitted That Met QC Criteria: March 1, 2023
• First Posted (Actual): March 2, 2023

Study Record Updates

• Last Update Posted (Actual): March 2, 2023
• Last Update Submitted That Met QC Criteria: March 1, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Blood-Borne Infections; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; Immunologic Deficiency Syndromes; Immune System Diseases; HIV Infections
• Other Study ID Numbers: 3514

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No