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Status unknownNCT05752578(3514)Updated Mar 2, 2023

Perspective Memory and Executive Functions in HIV+ Patients

An observational study in HIV Infections, sponsored by Fondazione Policlinico Universitario Agostino Gemelli IRCCS. Status unknown at 1 site in Italy. Per ClinicalTrials.gov, last updated 2023-03-02.

Sponsored by Fondazione Policlinico Universitario Agostino Gemelli IRCCS · Observational

The sponsor has not verified this record recently (last verified Jan 2023), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
100
Sex
All
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Study 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.
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Conditions studied

  • HIV Infections

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03

In context

HIV Infections

4,258 studies on the registry are indexed under HIV Infections; 240 are open to participants now.

This study's planned enrollment of 100 is below the median of 200 across 713 observational studies indexed under HIV Infections.

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Lead sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS is the lead sponsor of 920 studies on the registry; 529 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
Yes
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.

Eligibility criteria

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).
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
100 participants (estimated)
Patient registry
No

Groups and cohorts

  • 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

  • OtherNeuropsychological 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).

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What researchers measure

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).

    Time frame: 1 year

Secondary outcomes

  1. Influence of global cognitive performance on prospective memory

    Montreal Cognitive Assessment (MOCA) investigating global cognitive performance.

    Time frame: 1 year

  2. Influence of hot cognition on perspective memory

    Interpersonal Reactivity Index (IRI) with the purpose of assessing cognitive and affective empathy (Hot cognition).

    Time frame: 1 year

  3. Influence of cold cognition on perspective memory

    Modified Five Point Test aimed at assessing figurative fluency (Cold cognition).

    Time frame: 1 year

07

Study locations

1 of 1 sites recruiting
  • Fondazione Policlinico Universitario Agostino Gemelli IRCCS
    Roma, 00168, Italy
    Recruiting
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 2, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05752578
Lead sponsor
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Responsible party
Sponsor
First posted
Mar 2, 2023
Start date
Oct 10, 2020
Primary completion
Dec 31, 2023 (estimated)
Completion
Dec 31, 2023 (estimated)
Last update
Mar 2, 2023

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jan 2023. You cannot join it, but the record below documents what was studied.

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