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Could a new pill boost brain function in early Alzheimer's?

NCT ID NCT05619692

Symptom relief Sponsor: Supernus Pharmaceuticals, 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
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jun 26, 2026

Summary

This study tested a drug called SAGE-718 in 174 people with mild cognitive impairment or mild dementia due to Alzheimer's disease. The goal was to see if the drug could improve cognitive performance, like processing speed and everyday task ability. Participants took either SAGE-718 or a placebo as softgel capsules, and researchers measured changes in thinking tests and tracked any side effects.

What this could mean

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

Active substance
SAGE-718 (a drug taken as a softgel capsule)
What this could lead to
If successful, this could point toward a treatment that helps slow or improve cognitive decline in early Alzheimer's disease.
What could go wrong
This is an early Phase 2 trial with only 174 participants, so results may not be conclusive. The drug may not show meaningful benefit or could cause side effects.

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

174 people

The number who actually took part.

Started

Nov 2022

Finished

Jul 2024

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 80 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: 1. Meet the following criteria for mild cognitive impairment (MCI) or mild dementia due to Alzheimer's Disease (AD) at Screening: 1. A memory complaint reported by the participant or their study partner 2. A Clinical Dementia Rating (CDR) score of 0.5 to 1.0 (inclusive) with a memory box score ≥ 0.5 3. Essentially preserved activities of daily living, in the opinion of the investigator 4. Brain Magnetic Resonance Imaging (MRI) report, obtained within the 2 years preceding the Baseline Period, that is consistent with the diagnosis of AD with no clinically significant findings of non-AD pathology that could account for the observed cognitive impairment 2. Have a score of 15 to 25 (inclusive) on the Montreal Cognitive Assessment (MoCA) with years of education adjustment at Screening. Exclusion Criteria: 1. Have participated in a previous clinical study of SAGE-718, have participated in a previous gene therapy study, or have received study treatment in any other drug, biologic, or device trial within 30 days or 5 half-lives (whichever is longer), unless the participant participated solely in the placebo arm of the study. Additionally, participants who have received treatment with antisense oligonucleotides (ASO) will be excluded 2. Have a condition that precludes undergoing an MRI, in accordance with standard operating procedures at the imaging facility (eg, ferromagnetic metal in the body, claustrophobia), in a participant requiring MRI during Screening 3. Have any medical or neurological condition (other than AD) that might be contributing to the participant's cognitive impairment or history of cognitive decline 4. Have a history, presence, and/or current evidence of 1. Brain surgery, deep brain stimulation, or any history of hospitalization due to a brain injury 2. Possible or probable cerebral amyloid angiopathy, according to the Boston Criteria 3. Treatment with an anti-amyloid therapy (including biologics) without subsequent MRI demonstrating the absence of amyloid-related imaging abnormalities 4. Seizures or epilepsy, with the exception of childhood febrile seizures 5. Participants has a history of suicidal behavior within 2 years or answers "YES" to Questions 3, 4, or 5 on the Columbia-Suicide Severity Rating Scale (C-SSRS) at Screening or at Day 1 or is currently at risk of suicide in the opinion of the investigator 6. Have any of the following medical conditions: 1. Any clinically significant finding on 12-lead electrocardiogram (ECG) during Screening in the opinion of the investigator 2. Any clinically significant supine vital signs (heart rate, systolic and diastolic blood pressure) during Screening (note: vital sign measurements may be repeated once) 7. Have a history, presence, and/or current evidence of serologic positive results for human immunodeficiency virus (HIV)-1 or HIV-2, or hepatitis B or C 8. Have a positive pregnancy test, or be lactating, or intend to breastfeed during the study 9. Is known to be allergic to any of SAGE-718 excipients, including soy lecithin

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Conditions

The condition(s) this trial relates to.

Alzheimer disease Cognitive Dysfunction dementia

As listed by the trial registrant

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

Alzheimer's disease Mild cognitive impairment Mild dementia

Contacts and locations

Locations

  • Sage Investigational Site

    Gilbert, Arizona, 85297, United States

  • Sage Investigational Site

    Phoenix, Arizona, 85297, United States

  • Sage Investigational Site

    Lafayette, California, 94549, United States

  • Sage Investigational Site

    Long Beach, California, 90808, United States

  • Sage Investigational Site

    Redlands, California, 92374, United States

  • Sage Investigational Site

    San Diego, California, 92123, United States

  • Sage Investigational Site

    Sherman Oaks, California, 91403, United States

  • Sage Investigational Site

    Englewood, Colorado, 80120, United States

  • Sage Investigational Site

    Hollywood, Florida, 33024, United States

  • Sage Investigational Site

    Jacksonville, Florida, 32256, United States

  • Sage Investigational Site

    Miami, Florida, 33155, United States

  • Sage Investigational Site

    Palm Beach Gardens, Florida, 33410, United States

  • Sage Investigational Site

    Pensacola, Florida, 32504, United States

  • Sage Investigational Site

    Tampa, Florida, 33609, United States

  • Sage Investigational Site

    Winter Park, Florida, 32789, United States

  • Sage Investigational Site

    Decatur, Georgia, 30030, United States

  • Sage Investigational Site

    Savannah, Georgia, 31404, United States

  • Sage Investigational Site

    Honolulu, Hawaii, 96817, United States

  • Sage Investigational Site

    Meridian, Idaho, 83642, United States

  • Sage Investigational Site

    Chicago, Illinois, 60640, United States

  • Sage Investigational Site

    Charlestown, Massachusetts, 02129, United States

  • Sage Investigational Site

    Methuen, Massachusetts, 01844, United States

  • Sage Investigational Site

    Chesterfield, Missouri, 63005, United States

  • Sage Investigational Site

    Papillion, Nebraska, 68046, United States

  • Sage Investigational Site

    Toms River, New Jersey, 08755, United States

  • Sage Investigational Site

    Albuquerque, New Mexico, 87109, United States

  • Sage Investigational Site

    Brooklyn, New York, 11229, United States

  • Sage Investigational Site

    Buffalo, New York, 14203, United States

  • Sage Investigational Site

    Staten Island, New York, 10312, United States

  • Sage Investigational Site

    Raleigh, North Carolina, 27607, United States

  • Sage Investigational Site

    Abington, Pennsylvania, 19001, United States

  • Sage Investigational Site

    Memphis, Tennessee, 38119, United States

  • Sage Investigational Site

    Nashville, Tennessee, 37212, United States

  • Sage Investigational Site

    Austin, Texas, 78731, United States

  • Sage Investigational Site

    Dallas, Texas, 75231, United States

  • Sage Investigational Site

    Houston, Texas, 77030, United States

  • Sage Investigational Site

    Fairfax, Virginia, 22031, United States

  • Sage Investigational Site

    Bayamón, 00961, Puerto Rico

  • Sage Investigational Site

    Rio Piedras, 00935, Puerto Rico

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Other studies related to the condition(s) this trial covers.