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

Cognitive Impairment Clinical Trial

— COGITO  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03268109
• Other study ID #: AMR_2017_3
• Status: Recruiting
• Start date: September 22, 2017
• Est. completion date: September 22, 2024

Study information

• Verified date: June 2024
• Source: Fondation Ophtalmologique Adolphe de Rothschild
• Contact: Amélie Yavchitz, MD, PhD
• Phone: 0033148036454
• Email: ayavchitz[@]for.paris
• Is FDA regulated: No
• Study type: Observational

Clinical 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 to attenuate both functional and occupational disabilities due to cognitive impairment.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 330
• Est. completion date: September 22, 2024
• Est. primary completion date: September 22, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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

• Informed consent signed For PLHIV

• HIV 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:

• Opportunistic infection < 5 years

• Contraindications to MRI

Related Conditions & MeSH terms

• Cognitive Dysfunction
• Cognitive Impairment
• HIV/AIDS
• Memory Impairment

Intervention

Other:
• assessment of cognitive impairment
Measure of Global Deficit Score

Locations

Country	Name	City	State
France	Fondation Ophtalmologique A. de Rothschild /URC	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Fondation Ophtalmologique Adolphe de Rothschild

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	cognitive impairment	cognitive impairment frequency, defined by a z-score = 1.65 in at least 2 cognitive domains	baseline