ClinicalTrials.gg
CompletedNCT03268109COGITOUpdated Jun 25, 2025

COGnitive ImpairmenT in Older HIV-infected Patients ≥ 65 Years Old

An observational study in Memory Impairment, HIV/AIDS and Cognitive Impairment, sponsored by Fondation Ophtalmologique Adolphe de Rothschild. Completed at 1 site in France. Open to participants aged 65 Years and older. Per ClinicalTrials.gov, last updated 2025-06-25.

Sponsored by Fondation Ophtalmologique Adolphe de Rothschild · Observational

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Study type
Observational
Model
Other
Time perspective
Cross-sectional
Enrollment
281
Ages
65 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-14

Among 31 studies in Memory Disorders with a site in France — 8 open to participants now, 10 under way, none of them phase 3. Memory Disorders · France.

Started
2017
the only one that year
Observational
7 of 31
1 open now
Registered
18th of 31
by date

Among the 31 studies in Memory Disorders with a site in France, this one is the only one that started in 2017, is one of 7 observational ones, and was the 18th registered.

Memory Disorders

373 studies on the registry are indexed under Memory Disorders; 67 are open to participants now.

Browse Memory Disorders studies →

Open to participants now

8 of the 31 studies in Memory Disorders with a site in France are open now. Recruiting first, the newest first:

3 more — sign in →

All 8 open studies →

A study can be open while its sites in France have not opened yet or have stopped. Only those recruiting at a site in France →

Who these studies take

Of the 54 Memory Disorders studies recruiting now, 27 (50%) set no upper age limit and 13 (24%) stop at 75 or younger; 3 take children under 18; 22 take healthy volunteers.

This study: 65 Years and older · all sexes · no healthy volunteers.

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02

Study summary

Despite combined antiretroviral therapy (cART), milder forms of HIV-associated neurocognitive disorders (HAND) persist in 20-50% of persons living with HIV (PLHIV). Since more PLH are at risk for HAND due to aging, the frequency of HAND in PLHIV ≥ 65 years old is important to quantify for planning early intervention to attenuate both functional and occupational disabilities due to cognitive impairment.

03

Conditions studied

  • Memory Impairment
  • HIV/AIDS
  • Cognitive Impairment
04

Who can participate

Ages eligible
65 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

cART-treated PLHIV ≥65 years old having a memory complaint and virologically controlled for at least 1 year and to compare PLHIV to HIV-uninfected individuals matched for age, sex and educational level

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Inclusion criteria

  • Personal or familial cognitive complaints
  • Individual aged ≥ 65 years old and \< 81 years old
  • Instrumental activities of daily living (IADL) score between 3-4
  • French speaking individual
  • signed For PLHIV
  • infection
  • Undetectable HIV viral load ≥ 1 year
  • Current cluster of differentiation (CD4) cell count > 100/mm3 For controls
  • negative HIV serology ≤ 6 months

Exclusion criteria

Exclusion Criteria:

  • Opportunistic infection \< 5 years
  • to MRI
Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

05

Study design

Observational model
Other
Time perspective
Cross-sectional
Enrollment
281 participants (actual)
Patient registry
No

Groups and cohorts

  • people living with HIV

    subjects infected with HIV and with cognitive complaints

    Other: assessment of cognitive impairment

  • control subjects

    subjects not infected with HIV and with cognitive complaints

    Other: assessment of cognitive impairment

Interventions

  • Otherassessment of cognitive impairment

    Measure of Global Deficit Score

06

What researchers measure

Primary outcomes

  1. cognitive impairment

    cognitive impairment frequency, defined by a z-score ≤ 1.65 in at least 2 cognitive domains

    Time frame: baseline

07

Study locations

1 site
  • Fondation Ophtalmologique A. de Rothschild /URC
    Paris, 75019, France
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Sep 2017 to primary completion in May 2025, 91 months.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 29, 2017
First posted
Aug 31, 2017
StartActual
Sep 22, 2017
Primary completionActual
May 12, 2025
CompletionActual
May 12, 2025
Last update
Jun 25, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jun 25, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03268109
Responsible party
Sponsor
First posted
Aug 31, 2017
Start date
Sep 22, 2017
Primary completion
May 12, 2025
Completion
May 12, 2025
Last update
Jun 25, 2025

Study contacts

Antoine Moulignier, MD
principal investigator · Fondation Ophtalmologique A. de Rothschild

Oversight

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

Not currently enrolling

This study is completed, as verified in Jun 2025. You cannot join it, but the record below documents what was studied.

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Discussion

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