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CompletedNCT03384784CHIUpdated Oct 17, 2024Results posted

Effect of Galantamine on Inflammation and Cognition

A Phase 2 interventional study of Galantamine and Placebo in HIV Associated Cognitive Motor Complex, sponsored by University of Pennsylvania. Completed at 1 site in United States. Open to participants aged 30 Years and older. Per ClinicalTrials.gov, last updated 2024-10-17.

Sponsored by University of Pennsylvania · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
63
Allocation
Randomized
Ages
30 Years and older
Sex
All
01

Study 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.

Read the detailed description

Although anti-retroviral therapy (ART) enhances life expectancy and overall quality of life (QoL), HIV-infected individuals are increasingly vulnerable to non-AIDS-related diseases including HIV-associated neurocognitive disorders (HAND). Inflammation is a primary mechanism in the pathogenesis of HAND and tobacco use may further exacerbate inflammation. Conversely, nicotine alone has anti-inflammatory effects suggesting that stimulating the cholinergic pathway via pharmacological treatment [e.g., galantamine (GAL)] may suppress inflammation and reverse or prevent neurocognitive deficits in HIV-1 infection. In this double-blind, placebo-controlled crossover study, HIV-infected individuals (N=120; 60 smokers, 60 nonsmokers) 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). All subjects will be stable on ART and the GAL dose will follow FDA guidelines. At the beginning and end of each treatment phase, inflammatory biomarkers and viral load will be assessed. Monocyte transcriptomics will also be assessed on a subset of the sample (n=60; 30/group). Neurocognition and clinical outcomes (e.g., QoL) will be measured at baseline and at 4-week intervals during each treatment phase. The primary outcomes are monocyte/macrophage and T-cell activation (CD16, CD163, and CC chemokine receptor type 2 or CCR2 expression; plasma CC chemokine ligand type 2 or CCL2 [MCP-1 or monocyte chemoattractant protein-1], sCD14; CD38/HLA-DR [cluster of differentiation 38/Human Leukocyte Antigen- antigen D Related] on CD8 [cluster of differentiation 8] cells) and neurocognitive performance (processing speed, verbal learning/memory, executive function). Exploratory outcomes include monocyte gene expression patterns and broad plasma cytokine analysis. This study will provide insight into the interactions among nAChR activation, HIV immune activation and pathogenesis, and tobacco use and has translational and therapeutic implications that could improve health outcomes among HIV-infected individuals.

02

Conditions studied

  • HIV Associated Cognitive Motor Complex

Keywords

  • HIV
  • Neurocognition
  • Inflammation
  • Galantamine
  • Nicotine
  • Tobacco Use
03

In context

AIDS Dementia Complex

41 studies on the registry are indexed under AIDS Dementia Complex; 2 are open to participants now.

This study's enrollment of 63 is above the median of 50 across 31 interventional studies indexed under AIDS Dementia Complex.

Browse AIDS Dementia Complex studies →

Lead sponsor

University of Pennsylvania is the lead sponsor of 1,668 studies on the registry; 235 are open to participants now.

Of its 158 completed or terminated interventional studies of FDA-regulated products, 109 (69%) have results posted.

Browse University of Pennsylvania studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
30 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

Eligible subjects will be males and females:

  1. At least 30 years old
  2. Diagnosed with -1 infection
  3. On stable ART regimens (no changes to treatment within 4 weeks of Intake visit)
  4. Viral load of less than or equal to 200 copies/mL
  5. Current cluster of differentiation (CD4) counts greater than 200

  6. If current or past diagnosis of bipolar disorder, eligible if:

    1. No psychotic features
    2. Montgomery-Asberg Depression Rating Scale (MADRS): total score less than 8 (past 4 weeks), suicidal item score less than 1 (past 4 weeks)
    3. Young Mania Rating Scale (Y-MRS): total score less than 8 (past 4 weeks), irritability, speech content, disruptive or aggressive behavior items score less than 3 (past 4 weeks)
    4. No psychiatric hospitalization or Emergency Room visits for psychiatric issues in the past 6 months
    5. No aggressive or violent acts or behavior in the past 6 months
  7. Able to communicate in English and provide written
  8. Will be residing in the geographic area for at least 7 months
  9. Not currently trying to quit smoking

  10. Smoking Status

    1. Smokers (HIV+S) will report at least 5 instances of smoking per day, on average for the past year and provide a breath carbon monoxide (CO) sample greater than 5 ppm at Intake and at the beginning of each treatment period
    2. Non-smokers (HIV+NS) will report smoking fewer than 100 cigarettes in their lifetime, or less than 5 pack years of smoking and no cigarettes in the last year. They will self-report no current use of any tobacco or nicotine product and will provide a CO sample of less than 3 ppm at Intake and at the beginning of each treatment period. If CO sample does not reflect self-report, the PI will be consulted to determine eligibility.

Exclusion criteria

Exclusion Criteria:

Subjects who present with and/or self-report the following criteria will not be eligible to participate in the study.

Smoking Behavior

  1. Current enrollment or plans to enroll in another smoking cessation program in the next 7 months.
  2. Regular (daily) use of electronic cigarettes, chewing tobacco, snuff, snus, cigars, cigarillos, or pipes.
  3. Current use or plans to use nicotine substitutes (gum, patch, lozenge, e-cigarette) or smoking cessation treatments in the next 7 months.

Alcohol/Drug Use

  1. 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)
  2. 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.

Medical/Psychiatric Conditions

  1. Women who are pregnant, planning a pregnancy or lactating
  2. Current diagnosis of unstable and untreated major depression (if stable for at least 30 days, eligible)
  3. Current or past diagnosis of psychotic disorder
  4. Cancer diagnosis within the past 6 months (except basal cell carcinoma)
  5. Major heart disease or stroke within the past 6 months
  6. Uncontrolled hypertension (systolic blood pressure greater than 160 or diastolic blood pressure greater than 100).

  7. Medical conditions for use with galantamine:

    1. Diagnosis of Alzheimer's disease or dementia
    2. Epilepsy or other seizure disorder
  8. Bladder outflow obstruction
  9. Active co-infection (if cured, requires study physician approval)
  10. Liver function tests more than 20% outside of the normal range; Gamma-glutamyl transpeptidase (GGT) values more than 20% outside of the normal range. If Albumin/Globulin ratios are 20% outside of normal range the abnormal value will be evaluated for clinical significance by the Study Physician and eligibility will determined on a case-by-case basis.
  11. Renal disease or renal dysfunction (e.g., serum creatinine levels greater than 1.5 X ). Those with moderate hepatic impairment or 9 to 59 mL/min shall not exceed the 16 mg/day dose.
  12. Peptic ulcer disease (requires study physician approval)

  13. Suicide risk as indicated by at least one of the following on the Columbia Suicide Severity Rating Scale (the PI and/or study psychologist will be consulted to assess safety and determine eligibility in cases close to the eligibility cutoffs):

    1. Current suicidal ideation (within 30 days of enrollment)
    2. Two or more lifetime suicide attempts or episodes of suicidal behavior
    3. Any suicide attempt or suicidal behavior within 2 years of enrollment

Medication

  1. Current use or discontinuation within the last 14 days of:

    1. Quit smoking medications including varenicline (Chantix), bupropion (Wellbutrin)
    2. Anti-psychotic medications (e.g., Zyprexa, Clozaril, Seroquel, Risperdal). If used to treat psychotic symptoms. Other uses may be eligible pending physician approval).
    3. Systemic (e.g., Prednisone).
    4. Alzheimer's disease medications (e.g., Acetylcholinesterase inhibitors (ACIs), Aricept/donepezil, Exelon/rivastigmine, Tacrine, or memantine)
    5. Irritable bowel syndrome medication (e.g., Dicyclomine/Bentyl)
    6. Heart medications (e.g., quinidine).
    7. Muscle relaxants (e.g., Anectine/succinylcholine)
    8. Anti-seizure medications (e.g. Ativan, Banzel, Carbatrol, Dilantin, Lamictal, Gabitril, Lyrica, Neurontin, Tegretol, Topomax) if used to treat a seizure disorder or epilepsy. Other uses may be eligible.
    9. Urinary retention medications (e.g., Duvoid/bethanechol, Proscar/finasteride, Avodart/dutasteride, Dibenzyline/ phenoxybenzamine, Regitine/phentolamine)

  2. Daily use of:

    1. Opiate-containing medications for chronic pain (Duragesic/fentanyl patches, Percocet, Oxycontin). Smokers who report taking opiate-containing medications on an "as-needed" basis will be instructed to refrain from use until their study participation is over and that they will be tested to ensure they have complied with this requirement.
    2. (COPD) medication (e.g., Atrovent/Ipratropium Bromide)
  3. Known allergy to study medication.

Subjects will be instructed to refrain from using any study prohibited drugs/medications (both recreational and prescription) throughout their participation in the study.

Terms in these criteria, in plain language(8)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

Hepatitis C tests

Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.

After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.

ULN (upper limit of normal)

The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.

“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.

Creatinine clearance (CrCl)

How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

COPD

Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.

05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Triple (Participant, Care provider, Investigator)
Enrollment
63 participants (actual)

Study arms

  • Experimental
    Galantamine first

    This is a crossover study such that all participants receive both placebo and galantamine. Participants were randomized to receive galantamine first and placebo second. Timepoints Week 0 through Week 12 represent the first period and Weeks 16 through 28 represent the second period. This study follows the FDA-recommended dosing regimen for galantamine extended release (GAL ER): 4 weeks at 8 mg (once a day), 4 weeks at 16 mg (once a day), and 4 weeks at 24 mg (once a day). The University of Pennsylvania Investigational Drug Service (IDS) will oversee the randomization of all study medication, purchase study medication, manufacture matched placebo, encapsulate and package them in blister packs to maintain double-blind procedures.

    Drug: Galantamine · Drug: Placebo

  • Placebo comparator
    Placebo first

    This is a crossover study such that all participants receive both placebo and galantamine. Participants were randomized to receive galantamine first and placebo second. Timepoints Week 0 through Week 12 represent the first period and Weeks 16 through 28 represent the second period. Placebo ingredients will be purchased, encapsulated, and packaged into blister packs by the IDS at the University of Pennsylvania. Both active medication and placebo will look identical. The study medication assignments for each participant in this project is randomized and counterbalanced. This means that approximately 50% of participants will take galantamine during the first medication period, followed by the placebo in the second medication period. Alternatively, approximately 50% of participants will take the placebo during the first medication period, followed by galantamine during the second medication period.

    Drug: Galantamine · Drug: Placebo

Interventions

  • DrugGalantamine

    The study will be performed using the 8mg, 16mg and 24mg doses of galantamine hydrobromide-ER. The dosing regimen will be an initial 4 weeks of drug run-up at the lowest 8mg q.d. dose, followed by 16mg q.d. for the following 4 weeks, and the dose will be increased for the last 4 weeks to 24mg. Participants will be instructed to take one 8mg 16mg or 24mg pill (galantamine-ER or placebo) every morning, preferably with food.

    Also known as: Razadyne ER

  • DrugPlacebo

    Matched placebo will be made in-house using lactulose filler in gel capsules. Participants will be instructed to take one pills every morning for 12 weeks.

    Also known as: Sugar Pill

06

What researchers measure

Primary outcomes

  1. Change in Cognition

    Cognitive function will be assessed 4 times at Lab Visits. Executive function was measured by the task switch cost from the Color shape task, measured in ms. Executive function was also measured via response time (ms) and accuracy (# correct) on an N-back working memory task. Verbal learning and memory were measured by the Total Recall and Delayed Recall, respectively, from the Hopkins Verbal Learning Test. Response inhibition was measured by the stop signal reaction time (ms) from the Stop Signal Task. A composite score will be created by computed standardized z-scores for each measure (where the mean is 0 and the standard deviation is 1) and then averaging the z-scores. Measures of response time were reverse coded such that higher z-scores indicate better cognitive performance. The primary outcome is the change from baseline cognitive function after 12 weeks of treatment. Change in cognition will be measured during each treatment arm.

    Time frame: 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)

    Cellular markers of immune activation will be measured in whole blood and soluble markers of immune activation will be measured in plasma at Lab Visits. The primary outcome is the change in monocyte and T cell surface activation and soluble markers after 12 weeks of treatment. Because this is a within-subject crossover study, changes in cellular markers will be measured during each treatment arm.

    Time frame: 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)

    Cellular markers of immune activation will be measured in whole blood and soluble markers of immune activation will be measured in plasma at Lab Visits. The primary outcome is the change in monocyte and T cell surface activation and soluble markers after 12 weeks of treatment. Because this is a within-subject crossover study, changes in cellular markers will be measured during each treatment arm.

    Time frame: 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)

    Cellular markers of immune activation will be measured in whole blood and soluble markers of immune activation will be measured in plasma at Lab Visits. The primary outcome is the change in monocyte and T cell surface activation and soluble markers after 12 weeks of treatment. Because this is a within-subject crossover study, changes in cellular markers will be measured during each treatment arm.

    Time frame: 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)

    Cellular markers of immune activation will be measured in whole blood and soluble markers of immune activation will be measured in plasma at Lab Visits. The primary outcome is the change in monocyte and T cell surface activation and soluble markers after 12 weeks of treatment. Because this is a within-subject crossover study, changes in cellular markers will be measured during each treatment arm.

    Time frame: 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)

    Cellular markers of immune activation will be measured in whole blood and soluble markers of immune activation will be measured in plasma at Lab Visits. The primary outcome is the change in monocyte and T cell surface activation and soluble markers after 12 weeks of treatment. Because this is a within-subject crossover study, changes in cellular markers will be measured during each treatment arm.

    Time frame: Period1 Lab 1 (Week 0), Period 1 Lab 2 (Week 12), Period 2 Lab 1 (Week 16), Period 2 Lab 2 (Week 28)

07

Results

Posted Oct 17, 2024

Participant flow

First Intervention (12 Weeks)
Participant flow — First Intervention (12 Weeks)
MilestoneGalantamine FirstPlacebo First
Started2830
Completed2525
Not completed35
Washout (4 Weeks)
Participant flow — Washout (4 Weeks)
MilestoneGalantamine FirstPlacebo First
Started2525
Completed1724
Not completed81
Second Intervention (12 Weeks)
Participant flow — Second Intervention (12 Weeks)
MilestoneGalantamine FirstPlacebo First
Started1724
Completed1621
Not completed13

Outcome measures

PrimaryChange in Cognition

Cognitive function will be assessed 4 times at Lab Visits. Executive function was measured by the task switch cost from the Color shape task, measured in ms. Executive function was also measured via response time (ms) and accuracy (# correct) on an N-back working memory task. Verbal learning and memory were measured by the Total Recall and Delayed Recall, respectively, from the Hopkins Verbal Learning Test. Response inhibition was measured by the stop signal reaction time (ms) from the Stop Signal Task. A composite score will be created by computed standardized z-scores for each measure (where the mean is 0 and the standard deviation is 1) and then averaging the z-scores. Measures of response time were reverse coded such that higher z-scores indicate better cognitive performance. The primary outcome is the change from baseline cognitive function after 12 weeks of treatment. Change in cognition will be measured during each treatment arm.

Time frame:
Period1 Lab 1 (Week 0), Period 1 Lab 2 (Week 12), Period 2 Lab 1 (Week 16), Period 2 Lab 2 (Week 28)
Reported as:
Mean · Z-score
Change in Cognition
Z-scoreGalantamine FirstPlacebo First
Period1 Lab 1 (Week 0).018 ± .469.12 ± .509
Period 1 Lab 2 (Week 12)0.068 ± 0.6950.201 ± 0.615
Period 2 Lab 1 (Week 16)0.020 ± 0.7460.440 ± 0.578
Period 2 Lab 2 (Week 28)0.219 ± 0.8060.490 ± 0.472
PrimaryChange in Inflammation (MCP-1)

Cellular markers of immune activation will be measured in whole blood and soluble markers of immune activation will be measured in plasma at Lab Visits. The primary outcome is the change in monocyte and T cell surface activation and soluble markers after 12 weeks of treatment. Because this is a within-subject crossover study, changes in cellular markers will be measured during each treatment arm.

Time frame:
Period1 Lab 1 (Week 0), Period 1 Lab 2 (Week 12), Period 2 Lab 1 (Week 16), Period 2 Lab 2 (Week 28)
Reported as:
Mean · pg/mL
Change in Inflammation (MCP-1)
pg/mLGalantamine FirstPlacebo First
Period1 Lab 1 (Week 0)405.00 ± 277.68402.05 ± 206.56
Period1 Lab 2 (Week 12)423.33 ± 266.71337.01 ± 163.38
Period2 Lab 1 (Week 16)411.71 ± 221.34350.00 ± 149.55
Period2 Lab 2 (Week 28)410.76 ± 300.29334.91 ± 155.85
PrimaryChange in Inflammation (Percentage of CD14+ Monocytes Expressing CD8)

Cellular markers of immune activation will be measured in whole blood and soluble markers of immune activation will be measured in plasma at Lab Visits. The primary outcome is the change in monocyte and T cell surface activation and soluble markers after 12 weeks of treatment. Because this is a within-subject crossover study, changes in cellular markers will be measured during each treatment arm.

Time frame:
Period1 Lab 1 (Week 0), Period 1 Lab 2 (Week 12), Period 2 Lab 1 (Week 16), Period 2 Lab 2 (Week 28)
Reported as:
Mean · percentage of monocytes expressing CD8
Change in Inflammation (Percentage of CD14+ Monocytes Expressing CD8)
percentage of monocytes expressing CD8Galantamine FirstPlacebo First
Period1 Lab 1 (Week 0)7.125 ± 6.8595.590 ± 4.528
Period 1 Lab 2 (Week 12)5.747 ± 5.7895.221 ± 3.069
Period 2 Lab 1 (Week 16)4.329 ± 2.9336.570 ± 6.738
Period 2 Lab 2 (Week 28)6.150 ± 5.2576.916 ± 4.658
PrimaryChange in Inflammation (CD14)

Cellular markers of immune activation will be measured in whole blood and soluble markers of immune activation will be measured in plasma at Lab Visits. The primary outcome is the change in monocyte and T cell surface activation and soluble markers after 12 weeks of treatment. Because this is a within-subject crossover study, changes in cellular markers will be measured during each treatment arm.

Time frame:
Period1 Lab 1 (Week 0), Period 1 Lab 2 (Week 12), Period 2 Lab 1 (Week 16), Period 2 Lab 2 (Week 28)
Reported as:
Mean · ng/ml
Change in Inflammation (CD14)
ng/mlGalantamine FirstPlacebo First
Period1 Lab 1 (Week 0)1672.64 ± 440.691645.42 ± 741.79
Period 1 Lab 2 (Week 12)1807.66 ± 461.121512.70 ± 498.86
Period 2 Lab 1 (Week 16)1809.55 ± 330.041517.90 ± 515.77
Period 2 Lab 2 (Week 28)1631.96 ± 352.701521.68 ± 480.99
PrimaryChange in Inflammation (Percentage of CD14+ Monocytes Expressing CD163)

Cellular markers of immune activation will be measured in whole blood and soluble markers of immune activation will be measured in plasma at Lab Visits. The primary outcome is the change in monocyte and T cell surface activation and soluble markers after 12 weeks of treatment. Because this is a within-subject crossover study, changes in cellular markers will be measured during each treatment arm.

Time frame:
Period1 Lab 1 (Week 0), Period 1 Lab 2 (Week 12), Period 2 Lab 1 (Week 16), Period 2 Lab 2 (Week 28)
Reported as:
Mean · percentage of monocytes expressing CD163
Change in Inflammation (Percentage of CD14+ Monocytes Expressing CD163)
percentage of monocytes expressing CD163Galantamine FirstPlacebo First
Period1 Lab 1 (Week 0)88.68 ± 5.4889.11 ± 6.99
Period 1 Lab 2 (Week 12)80.03 ± 20.6783.90 ± 17.87
Period 2 Lab 1 (Week 16)86.64 ± 7.6787.15 ± 8.95
Period 2 Lab 2 (Week 28)86.44 ± 5.0690.94 ± 5.24
PrimaryChange in Inflammation (Percentage of CD14+ Monocytes Expressing CD16)

Cellular markers of immune activation will be measured in whole blood and soluble markers of immune activation will be measured in plasma at Lab Visits. The primary outcome is the change in monocyte and T cell surface activation and soluble markers after 12 weeks of treatment. Because this is a within-subject crossover study, changes in cellular markers will be measured during each treatment arm.

Time frame:
Period1 Lab 1 (Week 0), Period 1 Lab 2 (Week 12), Period 2 Lab 1 (Week 16), Period 2 Lab 2 (Week 28)
Reported as:
Mean · percentage of monocytes expressing CD16
Change in Inflammation (Percentage of CD14+ Monocytes Expressing CD16)
percentage of monocytes expressing CD16Galantamine FirstPlacebo First
Period1 Lab 1 (Week 0)64.18 ± 19.4964.90 ± 20.14
Period 1 Lab 2 (Week 12)67.44 ± 17.8868.02 ± 17.79
Period 2 Lab 1 (Week 16)74.78 ± 15.2769.04 ± 17.37
Period 2 Lab 2 (Week 28)67.83 ± 13.2359.78 ± 21.14

Adverse events

Collected over 28 weeks: From the start of treatment through the end of treatment. Non-serious events are listed at a 1% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Galantamine 8mg1/52 (1.9%)1/52 (1.9%)2/52 (3.8%)
Galantamine 16mg0/49 (0%)0/49 (0%)4/49 (8.2%)
Galantamine 24mg0/48 (0%)2/48 (4.2%)2/48 (4.2%)
Placebo0/47 (0%)2/47 (4.3%)3/47 (6.4%)
Most frequent serious events
Most frequent serious events
EventGalantamine 8mgGalantamine 16mgGalantamine 24mgPlacebo
Gastrointestinal BleedingGastrointestinal disorders0/520/491/481/47
Pulled muscleMusculoskeletal and connective tissue disorders0/520/490/481/47
Low HemoglobinBlood and lymphatic system disorders0/520/491/480/47
Bone fractureMusculoskeletal and connective tissue disorders1/520/490/480/47
Most frequent other events
Most frequent other events
EventGalantamine 8mgGalantamine 16mgGalantamine 24mgPlacebo
FatigueGeneral disorders1/524/491/481/47
DepressionPsychiatric disorders1/522/491/482/47
NauseaGastrointestinal disorders0/520/490/482/47

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)Galantamine FirstPlacebo FirstTotal
<=18 years000
Between 18 and 65 years283058
>=65 years000
Age, Continuous
Age, Continuous(years)Galantamine FirstPlacebo FirstTotal
Mean57.9 ± 3.757.3 ± 5.157.6 ± 4.4
Sex: Female, Male
Sex: Female, Male(Participants)Galantamine FirstPlacebo FirstTotal
Female5813
Male232245
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)Galantamine FirstPlacebo FirstTotal
Hispanic or Latino314
Not Hispanic or Latino252954
Unknown or Not Reported000
Race (NIH/OMB)
Race (NIH/OMB)(Participants)Galantamine FirstPlacebo FirstTotal
American Indian or Alaska Native000
Asian000
Native Hawaiian or Other Pacific Islander000
Black or African American211940
White41014
More than one race101
Unknown or Not Reported213
Region of Enrollment
Region of Enrollment(participants)Galantamine FirstPlacebo FirstTotal
United States283058
Smoking History
Smoking History(Participants)Galantamine FirstPlacebo FirstTotal
Non-Smoker102232
Current Smoker18826
CD4 Levels at Intake
CD4 Levels at Intake(cells/microliter)Galantamine FirstPlacebo FirstTotal
Mean769.8 ± 311.2611.6 ± 201.1687.9 ± 269.7

1 further baseline measures are reported on the registry.

08

Study locations

1 site
  • Center for Interdisciplinary Research on Nicotine Addiction, University of Pennsylvania
    Philadelphia, Pennsylvania 19104, United States
09

References and documents

Study documents

PDFs hosted by the registry, ClinicalTrials.gov.

Individual participant data

Plan to share: Yes — The final dataset will include demographic and behavioral assessments and laboratory data bio-specimens. Because the dataset will contain personal health information, identifying information will be collected. Even though the final dataset will be stripped of identifiers prior to release for sharing, investigators will do the following to reduce the possibility confidentiality loss. We will make the data and associated documentation available to users only under a data-sharing agreement that provides for: (1) a commitment to using data only for research purposes and not to identify any individual participant; (2) a commitment to securing the data using appropriate computer technology; and (3) a commitment to destroying or returning the data after analyses are completed. Transcriptomic data will be deposited with a public access database such as NCBI's Gene Expression Omnibus (GEO) database (http://www.ncbi.nlm.nih.gov/geo/)

Supporting information: Study protocol, Statistical analysis plan, Informed consent form

Time frame: Data will be made available starting 6 months after the summary data are published or January 2024 (whichever comes first) and will be made available for 5 years.

Access criteria: The PIs will review requests for data and all users must sign a data sharing agreement as described above.

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 17, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT03384784
Lead sponsor
University of Pennsylvania
Collaborators
National Institute on Drug Abuse (NIDA)
Responsible party
Sponsor
First posted
Dec 27, 2017
Start date
Oct 30, 2017
Primary completion
May 31, 2022
Completion
May 31, 2022
Results posted
Oct 17, 2024
Last update
Oct 17, 2024

Study contacts

Rebecca L Ashare, PhD
principal investigator · University of Pennsylvania

Oversight

FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2024. You cannot join it, but the record below documents what was studied.

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Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

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Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Studies of the drug tested here: Galantamine

Other studies in this condition

AIDS Dementia Complex →

Other studies from this sponsor

University of Pennsylvania →

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