60 Participants Needed

Scopolamine for Memory Loss

BL
Overseen ByBradley Lega, MD
Age: 18 - 65
Sex: Any
Trial Phase: Phase < 1
Sponsor: University of Texas Southwestern Medical Center
Approved in 2 JurisdictionsThis treatment is already approved in other countries

Trial Summary

What is the purpose of this trial?

The goal of this study is to learn about the effects of scopolamine (an anticholinergic drug) on areas of the brain involved in memory, and changes it may have on brain activity. The investigators will do this by testing epileptic patients who are already undergoing intracranial surgery for seizure monitoring, and measuring the activity from the brain areas being assessed. The main questions it aims to answer are 1) whether scopolamine changes memory activity solely at encoding (the time when the person perceives and determines to remember an item or event) as has previously been found, or if it also can selectively impact retrieval (when the item or event which has been processed is recalled or remembered), and 2) what the nature of the brain activity changes is. Participants will complete two treatment arms. One of these will be with the drug, and the other will be with a saline solution, so that the participants are unaware which session the actual drug has been received. Patients will complete a verbal and/or spatial task each of the two days. An anesthesiologist will administer either the drug or the saline at a critical point which addresses both of the research questions. Researchers will compare the brain activity between the two treatment arms to determine what brain activity changes, and at what time point during memory formation.

Do I have to stop taking my current medications for the trial?

The trial information does not specify if you need to stop taking your current medications. However, you should discuss your current medications with the study team to ensure they don't interfere with the trial.

What data supports the effectiveness of the drug Scopolamine for memory loss?

The research indicates that scopolamine can cause temporary memory impairments, which are used as a model to study Alzheimer's disease. However, there is no direct evidence from the provided studies that scopolamine is effective in treating memory loss; instead, it is used to simulate memory deficits for research purposes.12345

How is the drug scopolamine unique for treating memory loss?

Scopolamine is unique because it is administered through a transdermal patch, which provides a steady release of the drug over three days, potentially minimizing side effects compared to oral or injectable forms. It acts as a muscarinic antagonist, which means it blocks certain receptors in the brain, and is being studied for its effects on memory and cognition.14678

Research Team

Bradley Lega, M.D.: Neurological ...

Bradley Lega, MD

Principal Investigator

University of Texas Southwestern Medical Center

Eligibility Criteria

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.

Inclusion Criteria

Able to read, understand, and provide written, dated informed consent prior to screening.
Your body mass index (BMI) is between 18 and 35.
My doctor has recommended I undergo a detailed brain monitoring procedure for epilepsy.
See 2 more

Exclusion Criteria

I have been diagnosed with an enlarged prostate.
I have a nerve condition caused by my immune system.
I have a history of narrow-angle glaucoma.
See 10 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive either scopolamine or saline and complete memory tasks

2 days
2 visits (in-person)

Follow-up

Participants are monitored for memory-related changes in brain electrical activity

1-3 hours post-intervention each day

Treatment Details

Interventions

  • Placebo
  • Scopolamine
Trial OverviewThe 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.
Participant Groups
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.

Scopolamine is already approved in United States, Canada for the following indications:

🇺🇸
Approved in United States as Transderm-Scop for:
  • Prevention of nausea and vomiting after anesthesia, narcotic pain medicines, and surgery
  • Prevention of nausea and vomiting caused by motion sickness
🇨🇦
Approved in Canada as Transderm-V for:
  • Prevention of nausea and vomiting after anesthesia, narcotic pain medicines, and surgery
  • Prevention of nausea and vomiting caused by motion sickness

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Texas Southwestern Medical Center

Lead Sponsor

Trials
1,102
Recruited
1,077,000+

National Institute of Neurological Disorders and Stroke (NINDS)

Collaborator

Trials
1,403
Recruited
655,000+

Findings from Research

Chronic transdermal administration of scopolamine for 72 hours resulted in sustained impairments in visual function, such as near-point vision and pupil size, indicating ongoing peripheral effects.
Memory and attention impairments peaked one day after patch application but were not present three days later, suggesting that while scopolamine can model certain aspects of Alzheimer's disease, its effects on memory may be temporary.
The scopolamine model of dementia: chronic transdermal administration.Brazell, C., Preston, GC., Ward, C., et al.[2011]
FK960, a novel antidementia drug, effectively improved visual recognition memory deficits in rhesus monkeys caused by scopolamine, indicating its potential to counteract cholinergic dysfunction associated with dementia.
In comparison to physostigmine, which also restored memory deficits, FK960 showed promise in enhancing memory performance without significant side effects when administered alone, suggesting its therapeutic potential for treating dementia.
FK960 [N-(4-acetyl-1-piperazinyl)-p-fluorobenzamide monohydrate], a novel potential antidementia drug, improves visual recognition memory in rhesus monkeys: comparison with physostigmine.Matsuoka, N., Aigner, TG.[2018]
Tacrine effectively blocked the learning deficits caused by lower doses of scopolamine, anisodine, atropine, and anisodamine in mice, indicating its potential as a cognitive enhancer against these amnesic agents.
While tacrine showed strong antagonistic effects on avoidance-learning deficits, it was less effective against higher doses of the same amnesic agents, suggesting a dose-dependent response in its efficacy.
Learning deficits induced by 4 belladonna alkaloids are preferentially attenuated by tacrine.Pan, SY., Han, YF.[2019]

References

The scopolamine model of dementia: chronic transdermal administration. [2011]
FK960 [N-(4-acetyl-1-piperazinyl)-p-fluorobenzamide monohydrate], a novel potential antidementia drug, improves visual recognition memory in rhesus monkeys: comparison with physostigmine. [2018]
Learning deficits induced by 4 belladonna alkaloids are preferentially attenuated by tacrine. [2019]
Pharmacokinetics and pharmacodynamics of scopolamine after subcutaneous administration. [2022]
Transdermal physostigmine in the treatment of Alzheimer's disease. [2019]
Choline pivaloyl esters improve in rats cognitive and memory performances impaired by scopolamine treatment or lesions of the nucleus basalis of Meynert. [2018]
Overnight transdermal scopolamine patch administration has no clear effect on cognition and emotional processing in healthy volunteers. [2023]
Pharmacokinetics and pharmacodynamics in clinical use of scopolamine. [2022]