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

Sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS (Other)

Overall Status

Recruiting

CT.gov ID

NCT05752578

Collaborator

(none)

100

Enrollment

Location

38.7

Anticipated Duration (Months)

2.6

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
HIV Infections	Other: Neuropsychological testing

Study Design

Study Type:

Observational

Anticipated Enrollment :

100 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Oct 10, 2020

Anticipated Primary Completion Date :

Dec 31, 2023

Anticipated Study Completion Date :

Dec 31, 2023

Arms and Interventions

Arm	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).

Arm

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

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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).

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Fondazione Policlinico Universitario Agostino Gemelli IRCCS	Roma		Italy	00168

Sponsors and Collaborators

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

ClinicalTrials.gov Identifier:

NCT05752578

Other Study ID Numbers:

3514

First Posted:

Mar 2, 2023

Last Update Posted:

Mar 2, 2023

Last Verified:

Jan 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

HIV Infections

Study Results

No Results Posted as of Mar 2, 2023