60 Participants NeededMy employer runs this trial

Galantamine for Metabolic Syndrome in Spinal Cord Injury

Recruiting at 2 trial locations
OB
Overseen ByOna Bloom, PhD
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether galantamine, a drug typically used for Alzheimer's disease, can reduce inflammation associated with metabolic syndrome (a group of risk factors like high blood sugar and cholesterol) in individuals with spinal cord injuries. The study assesses participants' tolerance to the drug and its potential effectiveness. Participants will take the medication daily over several weeks, with researchers closely monitoring any changes. Ideal candidates are wheelchair users who have had a spinal cord injury for at least a year and experience issues like obesity and high blood sugar. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to significant medical advancements.

Will I have to stop taking my current medications?

The trial excludes participants who are on medications that interact with galantamine, so you may need to stop taking certain medications if they interact with the study drug.

Is there any evidence suggesting that galantamine is likely to be safe for humans?

Research has shown that galantamine, the drug tested in this study, is generally safe for use. In previous studies involving 3,956 patients, researchers carefully assessed the safety of galantamine in its extended-release form. Most participants tolerated the medication well, experiencing side effects similar to those of the regular tablet form. Commonly reported issues include dizziness and sleepiness, which could affect activities like driving. However, these side effects were not severe for most users. Additionally, the FDA has already approved galantamine for treating Alzheimer's disease, providing extra reassurance about its safety.12345

Why do researchers think this study treatment might be promising for metabolic syndrome in spinal cord injury?

Galantamine Hydrobromide Extended Release is unique because it targets metabolic syndrome in individuals with spinal cord injury, a condition that currently lacks specialized treatments. Unlike traditional metabolic syndrome treatments, which often involve lifestyle changes and medications like metformin or statins, galantamine works differently by modulating the cholinergic system. This mechanism may help improve glucose metabolism and reduce inflammation, offering a novel approach to managing metabolic disturbances in the context of spinal cord injury. Researchers are excited about its potential to address this underserved need and improve the quality of life for affected individuals.

What evidence suggests that galantamine might be an effective treatment for metabolic syndrome in spinal cord injury?

Research has shown that galantamine can reduce key markers of inflammation by over 25%, which is crucial for treating metabolic syndrome. Inflammation significantly contributes to metabolic syndrome, and reducing it can improve symptoms. Additionally, small doses of galantamine have lowered insulin resistance, another component of metabolic syndrome. This trial will assess the effects of galantamine in participants with spinal cord injuries, aiming to manage the condition effectively. Although galantamine is primarily known as a treatment for Alzheimer's, these findings suggest it could offer benefits beyond dementia care.12456

Are You a Good Fit for This Trial?

This trial is for adults with chronic spinal cord injury who also have metabolic syndrome, a group of conditions that increase the risk of heart disease and diabetes. Participants should not have other major health issues or be taking medications that could interfere with the study drug.

Inclusion Criteria

Tolerable bowel routine indicated by a score of <10 on the International SCI Bowel Function Data Set (ISCI-BDS)
Willingness to comply with all study procedures and availability for the duration of the study
Provision of signed and dated informed consent form
See 9 more

Exclusion Criteria

Triglyceride levels ≥400 mg/dL
Resting heart rate <45 bpm
Score of 10 or greater on the ISCI-BDS v2.1 indicating moderate to severe neurogenic bowel dysfunction
See 10 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1 week
1 visit (in-person)

In-Lab Observation

Single 8mg dose of galantamine administered orally with at least 5 hours of monitored observation

1 day
1 visit (in-person)

Outpatient Treatment

Participants receive 8mg galantamine daily for Weeks 1-4, escalating to 16mg daily for Weeks 5-12 based on tolerability

12 weeks
4 visits (in-person), weekly phone calls

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks
2 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

  • Galantamine Hydrobromide Extended Release

Trial Overview

The study is testing galantamine (usually used for Alzheimer's) to see if it can help reduce inflammation linked to metabolic syndrome in people with long-term spinal cord injuries. The focus is on how well participants tolerate the drug and its early effects.

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: Galantamine ERExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Northwell Health

Lead Sponsor

Trials
481
Recruited
470,000+

Bronx Veterans Medical Research Foundation, Inc

Collaborator

Trials
10
Recruited
750+

Kessler Institute for Rehabilitation

Industry Sponsor

Trials
23
Recruited
1,100+

Citations

Pilot Study of Galantamine to Treat Metabolic Syndrome in ...

The purpose of this research study is to measure the tolerability and preliminary efficacy of a drug, galantamine, to treat metabolic ...

Pilot Study of Galantamine to Treat Metabolic Syndrome in ...

The purpose of this research study is to measure the tolerability and preliminary efficacy of a drug, galantamine, to treat metabolic ...

Galantamine - StatPearls - NCBI Bookshelf - NIH

Galantamine alone or along with memantine is effective in the treatment of cognitive impairment due to traumatic brain injury [14][15][16].

galantamine hydrobromide extended release capsules ...

PAT-galantamine ER may cause adverse reactions (such as dizziness and somnolence), which could affect the ability to drive or use machines, ...

Pilot Study of Galantamine to Treat Metabolic Syndrome in ...

The purpose of this research study is to measure the tolerability and preliminary efficacy of a drug, galantamine, to treat metabolic syndrome (MetS) by ...

GALANTAMINE HYDROBROMIDE capsule, extended release

The safety of the extended-release capsule and immediate-release tablet formulations of galantamine was evaluated in 3,956 galantamine-treated patients who ...