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Anticholinergic

Scopolamine for Memory Loss

Phase < 1

Recruiting

Led By Bradley C Lega, MD

Research Sponsored by University of Texas Southwestern Medical Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age 18 - 55 years, all races/ethnicities, and both genders are eligible.

Be between 18 and 65 years old

Must not have

Patients with BPH.

Patients with autoimmune neuropathy.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, at day 2 post-intervention (approx. within 1-3 hrs)

Summary

This trial will investigate how an anticholinergic drug affects areas of the brain involved in memory and brain activity. Participants will receive the drug or a placebo to compare brain activity changes.

Who is the study for?

This trial is for adults aged 18-55 with epilepsy, in good health otherwise, and scheduled for intracranial surgery. They must have a BMI of 18-35 kg/m2 and be able to consent. Excluded are those with significant health issues like heart problems, liver failure, certain neurological conditions, glaucoma, gastrointestinal blockages or pregnant women.

What is being tested?

The study tests how scopolamine affects memory-related brain activity in epileptic patients during surgery. Participants receive either the drug or a placebo on different days while completing memory tasks. Brain activity is recorded to see if scopolamine influences memory encoding or retrieval.

What are the potential side effects?

Scopolamine can cause dry mouth, blurred vision, dizziness, confusion and difficulty urinating. It may also worsen conditions like BPH (enlarged prostate), narrow-angle glaucoma or myasthenia gravis.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 18 and 55 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have been diagnosed with an enlarged prostate.

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I have a nerve condition caused by my immune system.

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I have a history of narrow-angle glaucoma.

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I have liver failure.

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I am not pregnant, breastfeeding, and I passed a drug screening test.

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My thyroid is overactive and not controlled by medication.

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I have a history of myasthenia gravis, obstructive uropathy, or porphyria.

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I have had a blockage in my stomach or intestines.

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I do not have any ongoing heart problems.

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I have had kidney problems in the past.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, at day 2 post-intervention (approx. within 1-3 hrs)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, at day 2 post-intervention (approx. within 1-3 hrs)

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, at day 2 post-intervention (approx. within 1-3 hrs) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Memory-related changes in brain electrical activity in participants from baseline at Day 1 post-intervention (approx. within 1-3 hrs)

Memory-related changes in brain electrical activity in participants from baseline at Day 2 post-intervention (approx. within 1-3 hrs)

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Scopolamine (0.4mg)Experimental Treatment1 Intervention

Subjects will receive a dose of scopolamine (0.4mg) on each day. Approximately 15 minutes after administration, the participant will then complete either an episodic or a spatial memory task session. If the patient completed the sham session already, this session will take place the day following the initial session, or at least four half-lives after the first session.

Group II: PlaceboPlacebo Group1 Intervention

Subjects will receive saline (0.4mg) via IV on each day. Approximately 15 minutes after administration, the participant will then complete either an episodic or a spatial memory task session. If the patient completed the scopolamine session already, this session will take place the day following the initial session, or at least four half-lives after the first session.

0 / 11Eligibility criteria met