Memory ImpairmentCOGITONCT03268109
COGnitive ImpairmenT in Older HIV-infected Patients ≥ 65 Years Old
An observational study of Memory Impairment and HIV/AIDS, run by Fondation Ophtalmologique Adolphe de Rothschild at 1 site in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Memory Impairment, HIV/AIDS, Cognitive Impairment
- What is being tested?
- assessment of cognitive impairment
- How many people
- 281 participants
- Where
- 1 siteFrance
- Study dates
- 22 Sep 2017to 12 May 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
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
Who may be able to join
- 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
- Informed consent signed For PLHIV
- HIV infection
Show all 9Show fewer
- Undetectable HIV viral load ≥ 1 year
- Current cluster of differentiation (CD4) cell count > 100/mm3 For controls
- negative HIV serology ≤ 6 months
Who cannot join
- Opportunistic infection < 5 years
- Contraindications to MRI
Trial locations and contacts
1 site in 1 country.
About this study
Official title: COGnitive ImpairmenT in Older HIV-infected Patients ≥ 65 Years Old.
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.
- Conditions
- Memory Impairment, HIV/AIDS, Cognitive Impairment
- Being tested
- assessment of cognitive impairment
- Medical subject headings
- Memory Disorders, Acquired Immunodeficiency Syndrome, Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
assessment of cognitive impairmentOther
Measure of Global Deficit Score
| Study group | Role | What they receive |
|---|---|---|
| people living with HIV | subjects infected with HIV and with cognitive complaints Receives: Other: assessment of cognitive impairment | |
| control subjects | subjects not infected with HIV and with cognitive complaints Receives: Other: assessment of cognitive impairment |
What is being measured
The primary outcome is the main question the study is designed to answer.
cognitive impairment
cognitive impairment frequency, defined by a z-score ≤ 1.65 in at least 2 cognitive domains
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2017
- Study start22 Sep 2017
- Primary completion12 May 2025
- Study completion12 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Memory ImpairmentStudies of the same condition, open and under way.
- More trials run by Fondation Ophtalmologique Adolphe de RothschildThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 281 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fondation Ophtalmologique Adolphe de Rothschild
- Sponsor type
- Research network
- Responsible party
- Sponsor
- Investigators
- Antoine Moulignier, MD, Principal investigator, Fondation Ophtalmologique A. de Rothschild
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03268109
- Sponsor's protocol ID
- AMR_2017_3
- Acronym
- COGITO
- Status last verified
- Jun 2025
- First submitted
- 29 Aug 2017
- Last updated
- 25 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- COGnitive ImpairmenT in Older HIV-infected Patients ≥ 65 Years Old.
- ClinicalTrials.gov ID
- NCT03268109
- Acronym / sponsor ID
- COGITO / AMR_2017_3
- Conditions
- Memory Impairment, HIV/AIDS, Cognitive Impairment
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 281 participants (actual)
- Lead sponsor
- Fondation Ophtalmologique Adolphe de RothschildResearch network
- Study start
- 22 Sep 2017 (actual)
- Primary completion
- 12 May 2025 (actual)
- Study completion
- 12 May 2025 (actual)
- First posted
- 31 Aug 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| people living with HIV | – | Other: assessment of cognitive impairmentsubjects infected with HIV and with cognitive complaints |
| control subjects | – | Other: assessment of cognitive impairmentsubjects not infected with HIV and with cognitive complaints |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- 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
Key inclusion criteria (9 listed)
- 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
- Informed consent signed For PLHIV
Key exclusion criteria (2 listed)
- Opportunistic infection < 5 years
- Contraindications to MRI
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| assessment of cognitive impairmentMeasure of Global Deficit Score | Other | control subjects, people living with HIV |
Primary outcome
cognitive impairment
Time frame: baseline
cognitive impairment frequency, defined by a z-score ≤ 1.65 in at least 2 cognitive domains
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Antoine Moulignier, MD principal investigator
Fondation Ophtalmologique A. de Rothschild
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Memory Impairment and HIV/AIDS, run by Fondation Ophtalmologique Adolphe de Rothschild at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
cognitive impairment (time frame: baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jun 2025.