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New pill SAGE-718 tested for Alzheimer's memory loss

NCT ID NCT04602624

Disease control 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 an experimental drug called SAGE-718 in 26 people with mild cognitive impairment or mild dementia due to Alzheimer's disease. The main goal was to see if the drug is safe and tolerable, and to check for any effects on thinking and mood. Participants took SAGE-718 tablets by mouth, and researchers monitored side effects and changes in vital signs.

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 oral tablets
What this could lead to
If successful, this could point toward a new treatment option to help manage cognitive and neuropsychiatric symptoms in early Alzheimer's disease.
What could go wrong
This is a small, early-phase trial (26 participants) focused on safety, not proof of effectiveness. The drug may not show meaningful cognitive benefits or could have 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

26 people

The number who actually took part.

Started

Dec 2020

Finished

Sep 2021

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. Participant meets the following criteria for MCI or mild dementia due to AD at Screening: has a memory complaint, has clinical dementia rating (CDR) score of 0.5 to 1.0 (inclusive) with a memory box score ≥0.5, has essentially preserved activities of daily living 2. Participant has a score of 15 to 24 (inclusive) on the Montreal Cognitive Assessment at Screening 3. Participant has normal premorbid intelligence quotient (IQ) at Screening 4. Participant has a study partner who is reliable, competent, at least 18 years of age, willing to be available to the study center by phone, support study-specific activities, and accompany the participant to study visits as needed Exclusion Criteria: 1. Participant has any medical or neurological condition (other than AD) that might be contributing to the participant's cognitive impairment or history of cognitive decline 2. Participant has a history of brain surgery, deep brain stimulation, a significant head injury causing loss of consciousness greater than 30 minutes, or hospitalization due to a brain injury 3. Participant has a history, presence, and/or current evidence of a clinically-significant intracranial abnormality (eg, stroke, hemorrhage, space-occupying lesion) that could account for the observed cognitive impairment (excluding abnormalities consistent with underlying AD pathology) 4. Participant has a history of possible or probable cerebral amyloid angiopathy, according to the Boston Criteria 5. Participant has a history of seizures or epilepsy, with the exception of a single episode of febrile seizures in childhood 6. Participant has current or recent suicidality

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Conditions

The condition(s) this trial relates to.

Alzheimer disease cognitive disorder Cognitive Dysfunction dementia

As listed by the trial registrant

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

Alzheimer disease Cognitive dysfunction Mild dementia

Contacts and locations

Locations

  • Sage Investigational Site

    Phoenix, Arizona, 85044, United States

  • Sage Investigational Site

    Redlands, California, 92374, United States

  • Sage Investigational Site

    Miami, Florida, 33137, United States

  • Sage Investigational Site

    St. Petersburg, Florida, 33713, United States

  • Sage Investigational Site

    Decatur, Georgia, 30030, United States

  • Sage Investigational Site

    Decatur, Georgia, 30033, United States

  • Sage Investigational Site

    Gaithersburg, Maryland, 20877, United States

  • Sage Investigational Site

    Farmington Hills, Michigan, 48334, United States

  • Sage Investigational Site

    Omaha, Nebraska, 68130, United States

  • Sage Investigational Site

    North Canton, Ohio, 44720, United States

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