Trial · NCT03384784

Effect of Galantamine on Inflammation and Cognition

NCT03384784, Phase 2, Completed, University of Pennsylvania; results first posted 2024-10-17

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Effect of Galantamine on Inflammation and Cognition. Trials, record NCT03384784. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03384784

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Effect of Galantamine on Inflammation and Cognition
NCT number: NCT03384784
Status: Completed
Phases: Phase 2
Enrollment: 63 participants, actual
Lead sponsor: University of Pennsylvania
Conditions: HIV Associated Cognitive Motor Complex
Interventions: Galantamine, Placebo
First posted: 2017-12-27
Last updated: 2024-10-17
Results first posted: 2024-10-17

Source ClinicalTrials.gov

Registered outcomes6

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Change in Cognition	Period1 Lab 1 (Week 0), Period 1 Lab 2 (Week 12), Period 2 Lab 1 (Week 16), Period 2 Lab 2 (Week 28)	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.
Primary	Change in Inflammation (MCP-1)	Period1 Lab 1 (Week 0), Period 1 Lab 2 (Week 12), Period 2 Lab 1 (Week 16), Period 2 Lab 2 (Week 28)	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.
Primary	Change in Inflammation (Percentage of CD14+ Monocytes Expressing CD8)	Period1 Lab 1 (Week 0), Period 1 Lab 2 (Week 12), Period 2 Lab 1 (Week 16), Period 2 Lab 2 (Week 28)	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.
Primary	Change in Inflammation (CD14)	Period1 Lab 1 (Week 0), Period 1 Lab 2 (Week 12), Period 2 Lab 1 (Week 16), Period 2 Lab 2 (Week 28)	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.
Primary	Change in Inflammation (Percentage of CD14+ Monocytes Expressing CD163)	Period1 Lab 1 (Week 0), Period 1 Lab 2 (Week 12), Period 2 Lab 1 (Week 16), Period 2 Lab 2 (Week 28)	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.
Primary	Change in Inflammation (Percentage of CD14+ Monocytes Expressing CD16)	Period1 Lab 1 (Week 0), Period 1 Lab 2 (Week 12), Period 2 Lab 1 (Week 16), Period 2 Lab 2 (Week 28)	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.

Source ClinicalTrials.gov

Outcomes6

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Change in Cognition	Period1 Lab 1 (Week 0), Period 1 Lab 2 (Week 12), Period 2 Lab 1 (Week 16), Period 2 Lab 2 (Week 28)	Number analyzed at each time point reflects participants who had complete data for all cognitive measures.	Z-score	MEAN
PRIMARY	Change in Inflammation (MCP-1)	Period1 Lab 1 (Week 0), Period 1 Lab 2 (Week 12), Period 2 Lab 1 (Week 16), Period 2 Lab 2 (Week 28)	Number analyzed reflects participants who had complete data at each time point.	pg/mL	MEAN
PRIMARY	Change in Inflammation (Percentage of CD14+ Monocytes Expressing CD8)	Period1 Lab 1 (Week 0), Period 1 Lab 2 (Week 12), Period 2 Lab 1 (Week 16), Period 2 Lab 2 (Week 28)	Number analyzed reflects participants with complete data for this measure at each time point.	percentage of monocytes expressing CD8	MEAN
PRIMARY	Change in Inflammation (CD14)	Period1 Lab 1 (Week 0), Period 1 Lab 2 (Week 12), Period 2 Lab 1 (Week 16), Period 2 Lab 2 (Week 28)	Number analyzed reflects participants with complete data for this measure at each time point.	ng/ml	MEAN
PRIMARY	Change in Inflammation (Percentage of CD14+ Monocytes Expressing CD163)	Period1 Lab 1 (Week 0), Period 1 Lab 2 (Week 12), Period 2 Lab 1 (Week 16), Period 2 Lab 2 (Week 28)	Number analyzed reflects participants with complete data for this measure at each time point.	percentage of monocytes expressing CD163	MEAN
PRIMARY	Change in Inflammation (Percentage of CD14+ Monocytes Expressing CD16)	Period1 Lab 1 (Week 0), Period 1 Lab 2 (Week 12), Period 2 Lab 1 (Week 16), Period 2 Lab 2 (Week 28)	Number analyzed reflects participants with complete data for this measure at each time point.	percentage of monocytes expressing CD16	MEAN

Source ClinicalTrials.gov

Results by group48

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Spread	Units
Change in Cognition	Galantamine First	Period1 Lab 1 (Week 0)	.018	Standard Deviation .469	Z-score
Change in Cognition	Placebo First	Period1 Lab 1 (Week 0)	.12	Standard Deviation .509	Z-score
Change in Cognition	Galantamine First	Period 1 Lab 2 (Week 12)	0.068	Standard Deviation 0.695	Z-score
Change in Cognition	Placebo First	Period 1 Lab 2 (Week 12)	0.201	Standard Deviation 0.615	Z-score
Change in Cognition	Galantamine First	Period 2 Lab 1 (Week 16)	0.020	Standard Deviation 0.746	Z-score
Change in Cognition	Placebo First	Period 2 Lab 1 (Week 16)	0.440	Standard Deviation 0.578	Z-score
Change in Cognition	Galantamine First	Period 2 Lab 2 (Week 28)	0.219	Standard Deviation 0.806	Z-score
Change in Cognition	Placebo First	Period 2 Lab 2 (Week 28)	0.490	Standard Deviation 0.472	Z-score
Change in Inflammation (MCP-1)	Galantamine First	Period1 Lab 1 (Week 0)	405.00	Standard Deviation 277.68	pg/mL
Change in Inflammation (MCP-1)	Placebo First	Period1 Lab 1 (Week 0)	402.05	Standard Deviation 206.56	pg/mL

1 to 10 of 48Source ClinicalTrials.gov

See all 48 results by group

Participant flow18

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
First Intervention (12 Weeks)	STARTED	Galantamine First	28
First Intervention (12 Weeks)	STARTED	Placebo First	30
First Intervention (12 Weeks)	COMPLETED	Galantamine First	25
First Intervention (12 Weeks)	COMPLETED	Placebo First	25
First Intervention (12 Weeks)	NOT COMPLETED	Galantamine First	3
First Intervention (12 Weeks)	NOT COMPLETED	Placebo First	5
Washout (4 Weeks)	STARTED	Galantamine First	25
Washout (4 Weeks)	STARTED	Placebo First	25
Washout (4 Weeks)	COMPLETED	Galantamine First	17
Washout (4 Weeks)	COMPLETED	Placebo First	24

1 to 10 of 18Source ClinicalTrials.gov

See all 18 participant flow

Adverse events28

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	Depression	Psychiatric disorders	Galantamine 8mg	1	52	1
other	Depression	Psychiatric disorders	Galantamine 16mg	2	49	2
other	Depression	Psychiatric disorders	Galantamine 24mg	1	48	1
other	Depression	Psychiatric disorders	Placebo	2	47	2
other	Fatigue	General disorders	Galantamine 8mg	1	52	1
other	Fatigue	General disorders	Galantamine 16mg	4	49	4
other	Fatigue	General disorders	Galantamine 24mg	1	48	1
other	Fatigue	General disorders	Placebo	1	47	4
other	Nausea	Gastrointestinal disorders	Galantamine 8mg	0	52	0
other	Nausea	Gastrointestinal disorders	Galantamine 16mg	0	49	0

1 to 10 of 28Source ClinicalTrials.gov

See all 28 adverse events

Adverse event totals12

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Galantamine 8mg	1	52
Total, all-cause mortality	Galantamine 16mg	0	49
Total, all-cause mortality	Galantamine 24mg	0	48
Total, all-cause mortality	Placebo	0	47
Total, other adverse events	Galantamine 8mg	2	52
Total, other adverse events	Galantamine 16mg	4	49
Total, other adverse events	Galantamine 24mg	2	48
Total, other adverse events	Placebo	3	47
Total, serious adverse events	Galantamine 8mg	1	52
Total, serious adverse events	Galantamine 16mg	0	49

1 to 10 of 12Source ClinicalTrials.gov

See all 12 adverse event totals

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

Grants1

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

Project	Title	Principal investigators	Organization	Funder	Fiscal years
R01DA044906	Targeting the Cholinergic Pathway in HIV-associated Inflammation and Cognitive Dysfunction	ASHARE, REBECCA; COLLMAN, RONALD G	UNIVERSITY OF PENNSYLVANIA	NATIONAL INSTITUTE ON DRUG ABUSE	2017 to 2021

Source NIH RePORTER

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests5

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

Test	Named as	Source
1-Back Task	Primary outcome	ConductCognition
2-Back Task	Primary outcome	ConductCognition
Stop-Signal Task	Primary outcome	ConductCognition
Task Switching Test	Primary outcome	ConductCognition
Verbal Learning	Primary outcome	ConductCognition

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT03384784

GET https://conductscience.org/api/trials/v1/NCT03384784/results?page=2

API reference For AI assistants