Effect of Galantamine on Inflammation and Cognition (CHI)
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|ClinicalTrials.gov Identifier: NCT03384784|
Recruitment Status : Recruiting
First Posted : December 27, 2017
Last Update Posted : April 18, 2019
|Condition or disease||Intervention/treatment||Phase|
|HIV Associated Cognitive Motor Complex||Drug: Galantamine Drug: Placebo||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||150 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|Official Title:||Targeting the Cholinergic Pathway in HIV-associated Inflammation and Cognitive Dysfunction|
|Actual Study Start Date :||October 30, 2017|
|Estimated Primary Completion Date :||January 2022|
|Estimated Study Completion Date :||May 2022|
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.
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.
Other Name: Razadyne ER
Placebo Comparator: Placebo
12-week placebo-controlled medication 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.
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.
Other Name: Sugar Pill
- Change in Cognition [ 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) ]Cognitive function will be assessed 8 times throughout study participation at Lab Visits and Mid-treatment Visits. Participants will complete measures of executive function, verbal learning and memory and response inhibition. The primary outcome is the change from baseline cognitive function after 12 weeks of treatment. Because this is a within-subject crossover study, change in cognition will be measured during each treatment arm.
- Change in Inflammation [ 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) ]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.
- Monocyte Transcriptomics [ 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) ]Monocytes will be isolated from blood samples and analyzed for differences in monocyte expression between smoking and non-smoking groups and between treatment arms. Gene expression patterns will also be correlated with soluble and cell surface markers of inflammation.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03384784
|Contact: Rebecca L Ashare, PhDfirstname.lastname@example.org|
|Contact: Molly R Ruben, MPHemail@example.com|
|United States, Pennsylvania|
|Center for Interdisciplinary Research on Nicotine Addiction, University of Pennsylvania||Recruiting|
|Philadelphia, Pennsylvania, United States, 19104|
|Contact: Molly R Ruben, MPH 215-746-8420 firstname.lastname@example.org|
|Contact: Kristin Tederstrom 215-746-7142 email@example.com|
|Principal Investigator:||Rebecca L Ashare, PhD||University of Pennsylvania|