Perspective Memory and Executive Functions in HIV+ Patients

NCT05752578 | Unknown

• 1 other identifier: 3514
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

HIV Infections

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Influence of global cognitive performance on prospective memory

  1 year

• Influence of hot cognition on perspective memory

  1 year

• Influence of cold cognition on perspective memory

  1 year

Study Arms (2)

Subjects with HIV infection

Both male and female subjects, over 18 years of age, on antiretroviral therapy, native speakers of Italian

Other: Neuropsychological testing

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

Interventions

Neuropsychological testing OTHER

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; Subjects with HIV infection

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Fondazione Policlinico Universitario Agostino Gemelli IRCCS: lead

Study Sites (1)

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Roma, 00168, Italy

RECRUITING

MeSH Terms

Conditions

HIV Infections

Interventions

Neuropsychological Tests

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Intervention Hierarchy (Ancestors)

Psychological Tests; Behavioral Disciplines and Activities

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 30, 2023
• First Posted: March 2, 2023
• Study Start: October 10, 2020
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2023
• Last Updated: March 2, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)