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The WCM Advancing HIV Health through Epigenetic studies in Aging and Alzheimer's Disease (AHEAD) Study

Clinical Trial Details

This observational biorepository study aims to determine the overlapping and distinct immunological changes in individuals over 60 years of age with HIV-Associated Neurocognitive Disorders (HAND).

To accomplish this goal, the study will evaluate virologically suppressed people living with HIV-1 and HAND. A control group of virologically suppressed people living with HIV with normal cognition will also be enrolled, as well as 50 HIV-1 negative individuals.

All participants will answer questionnaires, undergo comprehensive neuropsychological testing, take functional and geriatric syndromes assessments, have MRIs, and get their blood drawn. Participants will be asked for a detailed medical history, including how long they’ve had HIV-1, any associated infections, HIV-specific diagnoses, medication history, and medication adherence.

These tests and procedures will take place over a 3-month period. After completion of the study, there will be annual follow ups for up to 5 years.

Serum, plasma, cerebrospinal fluid, urine specimens, stool samples and peripheral blood cells will also be collected and stored. A number of laboratory based tests may be done to these samples which will allow the study team to accurately identify molecular signatures of HAND. These studies will add significant value to improve the understanding of the molecular mechanisms of HAND and determine distinct disease processes that could provide targets for interventions.

Key Eligibility: 

Inclusion Criteria:
   1. Over 60 years old
   2. Self-reported HIV-1 positive (HIV group) or HIV-1 antibody negative (control group). For the HIV-1 negative group, HIV testing will be done at entry and, in the unlikely situation that it is positive, the participant will be switched to the HIV-1 positive group
  3. HIV-1 positive individuals will be virologically suppressed on stable combination antiretroviral therapy.    

HIV-1 negative control volunteers must not have:

   1. Significant memory or cognitive impairment
   2. Diagnosis of neurodegenerative disease
   3. Known functional impairment due to memory or cognitive impairment 
   
Detailed eligibility criteria will be discussed when contacting the study team.

Study contact by location

Upper East Side - Manhattan

Contact(s)

Barbara Hormann
bhormann@nyp.org

Primary Investigator(s)

Protocol ID(s)

Weill Cornell Medicine IRB #:

22-01024327

Sponsor:

NIH R01 AG063846

Status

Open to Enrollment

Age Group

Adult

Sponsor