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Could an Alzheimer's drug help treat metabolic syndrome in spinal cord injury?

NCT ID NCT07625332

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This pilot study is testing whether galantamine, a drug already approved for Alzheimer's disease, can safely reduce inflammation and treat metabolic syndrome in people with chronic spinal cord injury. The study will enroll 60 adults who use wheelchairs and have obesity-related waist measurements. Participants will take galantamine for 12 weeks, starting at 8 mg and possibly increasing to 16 mg daily, while researchers monitor side effects and changes in inflammation markers.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Galantamine (Razadyne ER)
What this could lead to
If it works, this could point toward a new way to manage metabolic syndrome and reduce inflammation in people with spinal cord injury.
What could go wrong
This is a small early-stage pilot study (60 people) testing a drug already approved for Alzheimer's, so it may not work for this new use. Side effects like changes in heart rate and blood pressure are possible.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2/3

Runs two stages together: whether the treatment works, then large-scale confirmation.

Participants

About 60 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Jun 2026

An estimate. Start dates often move.

Expected to finish

Dec 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

21 to 75 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Adults aged 21-75 years (male or female) * Chronic (≥1 year post injury) traumatic non-progressive spinal cord injury (SCI) * Wheelchair user for community mobility * Injury level of tetraplegia (cervical level) or paraplegia (all levels) * SCI-specific obesity indicated by waist circumference ≥94 cm * Resting heart rate \>45 bpm based on 10 measurements over 10 minutes * Without clinically significant cardiovascular abnormalities as indicated by 12-lead ECG * Tolerable bowel routine indicated by a score of \<10 on the International SCI Bowel Function Data Set (ISCI-BDS) * Metabolic Syndrome (MetS) defined by the presence of at least three of the following: (1) obesity indicated by SCI-specific waist circumference ≥94 cm, (2) elevated fasting glucose ≥100 mg/dL, (3) dyslipidemia: high triglycerides ≥150 mg/dL or low HDL cholesterol \<40 mg/dL for men and \<50 mg/dL for women, (4) C-reactive protein (CRP) levels \>1 mg/dL * Able to understand and communicate in English at the level of describing adverse event frequency and severity and completing validated outcome measures * Willingness to comply with all study procedures and availability for the duration of the study * Provision of signed and dated informed consent form Exclusion Criteria: * Diagnosis of neurological injury or condition other than SCI * Progressive condition that would be expected to change neurological status * Signs and symptoms of cardiovascular disease or cardiac arrhythmias * Resting heart rate \<45 bpm * Score of 10 or greater on the ISCI-BDS v2.1 indicating moderate to severe neurogenic bowel dysfunction * Severe concurrent medical disease, condition, or illness judged to be contraindicated by the site physician * Psychopathology documented in the medical record or history that may conflict with study objectives * Pregnancy (participant reported or determined by clinical lab test), women who plan to become pregnant, or women who are nursing during the study * Active cancer or currently in treatment for cancer * Triglyceride levels ≥400 mg/dL * Chronic use of medications with known or probable interactions with galantamine * Enrolled in another research study that is likely to interfere with conduct or results of the current study * Any other reason the site physician feels that participation is contraindicated

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    3 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • James J. Peters VA Medical Center

    RECRUITING

    The Bronx, New York, 10468, United States

  • Kessler Institute for Rehabilitation

    NOT_YET_RECRUITING

    West Orange, New Jersey, 07052, United States

  • Northwell Health

    RECRUITING

    Manhasset, New York, 11030, United States

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