Perspective Memory and Executive Functions in HIV+ Patients

HIV Infections Clinical Trial

— (3514)  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05752578
• Other study ID #: 3514
• Status: Recruiting
• Start date: October 10, 2020
• Est. completion date: December 31, 2023

Study information

• Verified date: January 2023
• Source: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

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).

Related Conditions & MeSH terms

• HIV Infections

Intervention

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).

Locations

Country	Name	City	State
Italy	Fondazione Policlinico Universitario Agostino Gemelli IRCCS	Roma

Sponsors (1)

Lead Sponsor	Collaborator
Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Country where clinical trial is conducted

Italy, 

Outcome

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