Effect of Galantamine on Inflammation and Cognition (NCT03384784) | Clinical Trial Compass
CompletedPhase 2
Effect of Galantamine on Inflammation and Cognition
United States63 participantsStarted 2017-10-30
Plain-language summary
This study tests whether galantamine (GAL) reduces HIV-related inflammation and cognitive deficits. In this double-blind placebo-controlled crossover study, HIV-infected individuals (N=120; 60 smokers and 60 non-smokers) will be randomized to 12 weeks of GAL or placebo, followed by a 4-week washout, then 12 weeks of GAL or placebo (arms switched). Outcomes are monocyte/macrophage and T cell activation and neurocognitive performance.
Who can participate
Age range30 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. At least 30 years old
✓. Diagnosed with HIV-1 infection
✓. On stable ART regimens (no changes to treatment within 4 weeks of Intake visit)
✓. Viral load of less than or equal to 200 copies/mL
✓. Current cluster of differentiation (CD4) counts greater than 200
✓. If current or past diagnosis of bipolar disorder, eligible if:
✓. No psychotic features
✓. Montgomery-Asberg Depression Rating Scale (MADRS): total score less than 8 (past 4 weeks), suicidal item score less than 1 (past 4 weeks)
Exclusion criteria
✕. Current enrollment or plans to enroll in another smoking cessation program in the next 7 months.
✕. Regular (daily) use of electronic cigarettes, chewing tobacco, snuff, snus, cigars, cigarillos, or pipes.
✕. Current use or plans to use nicotine substitutes (gum, patch, lozenge, e-cigarette) or smoking cessation treatments in the next 7 months.
✕. Current untreated and unstable diagnosis of substance abuse or dependence (if past use and if receiving treatment and stable for at least 30 days, eligible)
✕
What they're measuring
1
Change in Cognition
Timeframe: Period1 Lab 1 (Week 0), Period 1 Lab 2 (Week 12), Period 2 Lab 1 (Week 16), Period 2 Lab 2 (Week 28)
2
Change in Inflammation (MCP-1)
Timeframe: Period1 Lab 1 (Week 0), Period 1 Lab 2 (Week 12), Period 2 Lab 1 (Week 16), Period 2 Lab 2 (Week 28)
3
Change in Inflammation (Percentage of CD14+ Monocytes Expressing CD8)
Timeframe: Period1 Lab 1 (Week 0), Period 1 Lab 2 (Week 12), Period 2 Lab 1 (Week 16), Period 2 Lab 2 (Week 28)
4
Change in Inflammation (CD14)
Timeframe: Period1 Lab 1 (Week 0), Period 1 Lab 2 (Week 12), Period 2 Lab 1 (Week 16), Period 2 Lab 2 (Week 28)
5
Change in Inflammation (Percentage of CD14+ Monocytes Expressing CD163)
Timeframe: Period1 Lab 1 (Week 0), Period 1 Lab 2 (Week 12), Period 2 Lab 1 (Week 16), Period 2 Lab 2 (Week 28)
6
Change in Inflammation (Percentage of CD14+ Monocytes Expressing CD16)
Timeframe: Period1 Lab 1 (Week 0), Period 1 Lab 2 (Week 12), Period 2 Lab 1 (Week 16), Period 2 Lab 2 (Week 28)
. Positive urine drug screen for cocaine, methamphetamines, phencyclidine (PCP), barbiturates, ecstasy (MDMA), at Intake or Lab visits. Those who screen positive for amphetamines, benzodiazepines, methadone, oxycodone, and/or opiates (low level cut-off 300 ng/mL) and who are prescribed these medications will be reviewed on a case-by-case basis by the study physician and PIs (see Measures and Table 1 for details). Participants believed to have a false-positive result on the drug screen may continue in the study, with investigator approval.
✕. Women who are pregnant, planning a pregnancy or lactating
✕. Current diagnosis of unstable and untreated major depression (if stable for at least 30 days, eligible)
✕. Current or past diagnosis of psychotic disorder