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Can a daily pill alter brain activity in Alzheimer's disease?

NCT ID NCT07789873

Disease control Sponsor: Galimedix Therapeutics Inc Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 27, 2026 · Last updated Aug 28, 2026 · Updated 1 time

Summary

This Phase 2a trial tests an oral drug called GAL-101 in about 100 people with mild to moderate Alzheimer's disease. Participants take either 1200 mg of GAL-101 or a placebo pill once daily for 28 days, and neither they nor the study team know which they receive. The main goal is to check safety and tolerability, but researchers also measure brain-wave activity, spinal fluid biomarkers, and cognitive test performance to see if GAL-101 has any effect on the disease process.

What this could mean

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

Active substance
GAL-101 salt, an oral drug taken as two 600 mg tablets once daily for 28 days
What this could lead to
If GAL-101 proves safe and shows hints of affecting brain activity or Alzheimer's biomarkers, it could point toward a new oral treatment for early Alzheimer's disease.
What could go wrong
This is a small, short Phase 2a study focused on safety and tolerability, not proof of benefit. The 28-day treatment may be too brief to change the course of the disease, and the drug could fail in larger trials.

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

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 100 people

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

Expected to start

Feb 2027

An estimate. Start dates often move.

Expected to finish

Jul 2028

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

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

Ages

50 to 85 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: * Male or female participants aged 50 to 85 years, inclusive. * Clinical diagnosis of Alzheimer's disease at the mild or moderate dementia stage (Stages 4 or 5) according to the 2018 National Institute on Aging and Alzheimer's Association criteria * Evidence of amyloid-beta pathology based on cerebrospinal fluid biomarkers, amyloid-beta positron emission tomography, or plasma phosphorylated tau 217. * Evidence of cognitive decline during the previous year. * Availability of a reliable trial partner, caregiver, or legal representative who has contact with the participant for at least 10 hours per week and can support study participation. * Able and willing to provide informed consent and comply with study requirements. * In sufficiently good health, in the investigator's opinion, to participate in the study. * If receiving an acetylcholinesterase inhibitor or memantine, treatment must be at a stable dose for the protocol-specified period. Exclusion Criteria: * A neurological, psychiatric, cerebrovascular, or other medical condition that could explain the participant's cognitive impairment, interfere with study assessments, or create an unacceptable safety risk. * Previous treatment with anti-amyloid-beta immunotherapy. * Participation in another interventional clinical study or receipt of an investigational drug within 3 months before screening. * Use of prohibited medications or substances that could affect cognition, electroencephalography assessments, safety, or interpretation of the study results. * Clinically significant or unstable cardiovascular, respiratory, renal, hepatic, metabolic, infectious, or malignant disease. * Active major depression, schizophrenia, bipolar disorder, or clinically significant suicide risk. * Known or suspected hypersensitivity to GAL-101, placebo, or their components. * A scalp condition that would prevent adequate electroencephalography assessment. * Inability to comply with the study schedule or procedures. * Any other condition that, in the investigator's opinion, makes the participant unsuitable for the study.

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Conditions

The condition(s) this trial relates to.

Alzheimer disease Plaque, Amyloid

As listed by the trial registrant

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

Mild to moderate Alzheimer's disease

How to take part

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

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names. 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

Study contacts

  • Contact

    Email: •••••@•••••

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