Mental Ability Challenge Study in Adults With and Without HIV

Completed

Conditions studied: HIV-1-infection, Aging, Premature, Cognitive Impairment, Memory Impairment, HIV-Associated Cognitive Motor Complex

In brief

It is estimated that by 2016, nearly 50% of HIV-positive individuals in the US will be aged 50 or older, and up to 60% of those will experience some degree of cognitive impairment as they age. The purpose of this study is to evaluate the contribution of the neuronal cholinergic receptor system to the cognitive impairments seen in adults aging with chronic HIV Infection. By using anti-cholinergic challenge drugs to reversibly "stress" cognitive functioning, the investigators hope to understand whether the presence of the HIV virus in the brain impairs the neural system necessary for normal cognition, more than would be expected from normal cognitive aging.

Key facts

Study ID

NCT03244488

Run by

Vanderbilt University Medical Center

People needed

22

Starts

2015-12-01

Expected to finish

2018-12-01

Last updated by the study team

2019-02-25

Who can join

Age: 35 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 35 years of age or older;
• HIV-Positive (must be on ART's for at least 6 months, most recent viral load (within 6 months) <50, CD4+ count >200, must be diagnosed HIV-positive at least 5 years) or HIV-Negative, At-Risk Individuals
• Able and willing to give written informed consent
• Negative urine pregnancy test
• Adequate visual and auditory acuity to allow neuropsychological testing.

You may not qualify if…

• Unmanaged HIV Infection, identified by no current medication regimen or the presence of one or more AIDS-defining conditions
• Fagerstrom cigarettes per day (CPD) score of '2' indicating heavy use of nicotine
• An ART regimen including a Protease Inhibitor Medication
• A documented history of cardiac disease or abnormal ECG at Screening
• Current alcohol or substance abuse, particularly intravenously
• Current use of psychoactive medications (antipsychotics, benzodiazepines, etc.)
• Current Axis I or Axis II psychiatric disorder
• History of myocardial infarction in the past year or unstable or severe cardiovascular disease

Where it is running

• Vanderbilt University Medical Center — Nashville, Tennessee, United States

Full record on ClinicalTrials.gov

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