Mental Ability Challenge Study in Adults With and Without HIV

NCT03244488 | Completed FDA Drug

• 1 other identifier: 150929
• Study Type: observational
• Target: 22
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

HIV-1-infection; Aging, Premature; Cognitive Impairment; Memory Impairment; HIV-Associated Cognitive Motor Complex

Outcome Measures

Primary Outcomes (1)

• Cognitive Outcome - Lower verbal memory score

  Cognitive performance will be more significantly impaired by study medications in HIV-positive participants relative to HIV-negative participants, indicating impairment of cholinergic neurotransmitter system.

  2 hours

Secondary Outcomes (1)

• Age and HIV-Status Interaction - Slower CRTreaction time

  2 hours

Study Arms (2)

HIV-Positive

Patients will be administered each of 4 possible treatments: high dose (5 mcg/kg) scopolamine, high dose (20 mg) mecamylamine, a low dose combination (2.5mcg/kg and 10 mg) of scopolamine and mecamylamine, or placebo.

Drug: Scopolamine Injectable Product; Drug: Mecamylamine Pill

HIV-Negative

Patients will be administered each of 4 possible treatments: high dose (5 mcg/kg) scopolamine, high dose (20 mg) mecamylamine, a low dose combination (2.5mcg/kg and 10 mg) of scopolamine and mecamylamine, or placebo.

Drug: Scopolamine Injectable Product; Drug: Mecamylamine Pill

Interventions

Scopolamine Injectable Product DRUG

2.5 or 5 mcg/kg of scopolamine via IV

HIV-Negative; HIV-Positive

Mecamylamine Pill DRUG

10 or 20mg of mecamylamine orally

HIV-Negative; HIV-Positive

Eligibility Criteria

• Age: 35 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

HIV-Positive Healthy older adults and HIV-Negative Healthy older adults

You may qualify if:

• 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

Sponsors & Collaborators

• Vanderbilt University Medical Center: lead

Study Sites (1)

Vanderbilt University Medical Center

Nashville, Tennessee, 37212, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Blood samples collected from all participants for routine screening labs and APOE genotyping.

MeSH Terms

Conditions

Aging, Premature; Cognitive Dysfunction; Memory Disorders; AIDS Dementia Complex

Interventions

Mecamylamine

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Cognition Disorders; Neurocognitive Disorders; Mental Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Dementia; Brain Diseases; Central Nervous System Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Intervention Hierarchy (Ancestors)

Norbornanes; Bridged Bicyclo Compounds; Bridged-Ring Compounds; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds

Study Design

• Study Type: observational
• Observational Model: CASE CROSSOVER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Graduate Research Assistant

Study Record Dates

• First Submitted: July 27, 2017
• First Posted: August 9, 2017
• Study Start: December 1, 2015
• Primary Completion: December 1, 2018
• Study Completion: December 1, 2018
• Last Updated: February 25, 2019

Record last verified: 2019-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)