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Mild Cognitive ImpairmentPhase 2NCT05619692

A Study to Evaluate the Effects of SAGE-718 in Participants With Mild Cognitive Impairment or Mild Dementia Due to Alzheimer's Disease (AD)

A Phase 2 study testing SAGE-718 in people with Mild Cognitive Impairment and Mild Dementia, run by Supernus Pharmaceuticals, Inc. at 39 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The primary purpose of this study is to evaluate the effect of SAGE-718 on cognitive performance in participants with Alzheimer's Disease. Read more about this study

Who is it for?
Ages 50 to 80 years
What is being tested?
SAGE-718
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
174 participants
Where
39 sitesin 2 countries
Study dates
29 Nov 2022to 9 Jul 2024
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 50 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Meet the following criteria for mild cognitive impairment (MCI) or mild dementia due to Alzheimer's Disease (AD) at Screening:
  • A memory complaint reported by the participant or their study partner
  • A Clinical Dementia Rating (CDR) score of 0.5 to 1.0 (inclusive) with a memory box score ≥ 0.5
  • Essentially preserved activities of daily living, in the opinion of the investigator
  • 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
  • Have a score of 15 to 25 (inclusive) on the Montreal Cognitive Assessment (MoCA) with years of education adjustment at Screening.

Who cannot join

  • 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
  • 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
  • Have any medical or neurological condition (other than AD) that might be contributing to the participant's cognitive impairment or history of cognitive decline
  • Have a history, presence, and/or current evidence of
  • Brain surgery, deep brain stimulation, or any history of hospitalization due to a brain injury
  • Possible or probable cerebral amyloid angiopathy, according to the Boston Criteria
Show all 15Show fewer
  • Treatment with an anti-amyloid therapy (including biologics) without subsequent MRI demonstrating the absence of amyloid-related imaging abnormalities
  • Seizures or epilepsy, with the exception of childhood febrile seizures
  • 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
  • Have any of the following medical conditions:
  • Any clinically significant finding on 12-lead electrocardiogram (ECG) during Screening in the opinion of the investigator
  • Any clinically significant supine vital signs (heart rate, systolic and diastolic blood pressure) during Screening (note: vital sign measurements may be repeated once)
  • 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
  • Have a positive pregnancy test, or be lactating, or intend to breastfeed during the study
  • Is known to be allergic to any of SAGE-718 excipients, including soy lecithin

Trial locations and contacts

39 sites in 2 countries.

39 sites in 2 countries

United States37 sites

  • Sage Investigational Site

    Abington, Pennsylvania, 19001

  • Sage Investigational Site

    Albuquerque, New Mexico, 87109

  • Sage Investigational Site

    Austin, Texas, 78731

  • Sage Investigational Site

    Brooklyn, New York, 11229

  • Sage Investigational Site

    Buffalo, New York, 14203

  • Sage Investigational Site

    Charlestown, Massachusetts, 02129

  • Sage Investigational Site

    Chesterfield, Missouri, 63005

  • Sage Investigational Site

    Chicago, Illinois, 60640

  • Sage Investigational Site

    Dallas, Texas, 75231

  • Sage Investigational Site

    Decatur, Georgia, 30030

  • Sage Investigational Site

    Englewood, Colorado, 80120

  • Sage Investigational Site

    Fairfax, Virginia, 22031

  • Sage Investigational Site

    Gilbert, Arizona, 85297

  • Sage Investigational Site

    Hollywood, Florida, 33024

  • Sage Investigational Site

    Honolulu, Hawaii, 96817

  • Sage Investigational Site

    Houston, Texas, 77030

  • Sage Investigational Site

    Jacksonville, Florida, 32256

  • Sage Investigational Site

    Lafayette, California, 94549

  • Sage Investigational Site

    Long Beach, California, 90808

  • Sage Investigational Site

    Memphis, Tennessee, 38119

  • Sage Investigational Site

    Meridian, Idaho, 83642

  • Sage Investigational Site

    Methuen, Massachusetts, 01844

  • Sage Investigational Site

    Miami, Florida, 33155

  • Sage Investigational Site

    Nashville, Tennessee, 37212

  • Sage Investigational Site

    Palm Beach Gardens, Florida, 33410

  • Sage Investigational Site

    Papillion, Nebraska, 68046

  • Sage Investigational Site

    Pensacola, Florida, 32504

  • Sage Investigational Site

    Phoenix, Arizona, 85297

  • Sage Investigational Site

    Raleigh, North Carolina, 27607

  • Sage Investigational Site

    Redlands, California, 92374

  • Sage Investigational Site

    San Diego, California, 92123

  • Sage Investigational Site

    Savannah, Georgia, 31404

  • Sage Investigational Site

    Sherman Oaks, California, 91403

  • Sage Investigational Site

    Staten Island, New York, 10312

  • Sage Investigational Site

    Tampa, Florida, 33609

  • Sage Investigational Site

    Toms River, New Jersey, 08755

  • Sage Investigational Site

    Winter Park, Florida, 32789

Other trials in United States

Puerto Rico2 sites

  • Sage Investigational Site

    Bayamón, 00961

  • Sage Investigational Site

    Rio Piedras, 00935

Other trials in Puerto Rico

About this study

Official title: A Randomized, Double-blind, Placebo-controlled Study to Evaluate the Effects of SAGE-718 in Participants With Mild Cognitive Impairment or Mild Dementia Due to Alzheimer's Disease

The primary purpose of this study is to evaluate the effect of SAGE-718 on cognitive performance in participants with Alzheimer's Disease.

Being tested
SAGE-718, SAGE-718-matching Placebo
Keywords
SAGE-718, Cognitive dysfunction, N-methyl-D-aspartate (NMDA)
Medical subject headings
Cognitive Dysfunction, Alzheimer Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SAGE-718Drug

    Softgel lipid capsules.

  • SAGE-718-matching PlaceboDrug

    Softgel lipid capsules.

Study groups in NCT05619692
Study groupRoleWhat they receive
SAGE-718ExperimentalParticipants will receive SAGE-718, 1.2 milligrams (mg), orally, once daily (QD) for the first 6 weeks (Days 1 to 42), followed by 0.9 mg of SAGE-718 for the remainder of the treatment period up to Day 84.
Receives: Drug: SAGE-718
PlaceboPlacebo comparatorParticipants will receive SAGE-718-matching placebo, orally, QD, throughout the treatment period up to Day 84.
Receives: Drug: SAGE-718-matching Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change From Baseline in the Wechsler Adult Intelligence Scale-IV (WAIS-IV) Coding Test Score

    The WAIS-IV coding test is a valid and sensitive measure of cognitive dysfunction that correlates with real-world functional outcomes (e.g., the ability to accomplish everyday tasks) and recovery from functional disability, used to assess processing speed. The participant is required to identify the symbols matched to numbers using a key and write in the symbol beneath the associated number. The total score ranges from 0 to 135 and is based on the total number of codes correctly completed over a 120-second time limit. Higher scores indicate better processing speed. Positive change from baseline indicates better processing speed. Least Squares (LS) Means were calculated using a mixed-effects model for repeated measures (MMRM) approach.

    Measured: Baseline, Day 84

Secondary outcomes (3)

  1. Number of Participants With at Least One Treatment-Emergent Adverse Event (TEAE)

    An adverse event (AE) was defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom or disease temporally associated with the use of a medicinal (investigational) product whether or not related to the medicinal (investigational) product. A TEAE is defined as any AE on or after the first dose of IP or any worsening of a pre-existing medical condition/AE with onset after the start of IP and throughout the study.

    Measured: Up to Day 112

  2. Number of Participants With at Least One TEAE by Severity

    A TEAE is defined as any AE on or after the first dose of IP or any worsening of a pre-existing medical condition/AE with onset after the start of IP and throughout the study. Severity was assessed as:

    • Mild: symptoms barely noticeable to participant or does not make participant uncomfortable; does not influence performance or functioning; prescription drug not ordinarily needed for relief of symptoms
    • Moderate: symptoms of a sufficient severity to make participant uncomfortable; performance of daily activity is influenced; participant is able to continue in study; treatment for symptoms may be needed
    • Severe: symptoms cause severe discomfort; symptoms cause incapacitation or significant impact on participant's daily life; severity may cause cessation of treatment with IP; treatment for symptoms may be given and/or participant hospitalized.

    Participant with multiple instances of events is counted only once using maximum intensity.

    Measured: Up to Day 112

  3. Number of Participants Who Withdrew From Study Due to TEAEs

    An AE was defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom or disease temporally associated with the use of a medicinal (investigational) product whether or not related to the medicinal (investigational) product. A TEAE is defined as any AE on or after the first dose of IP or any worsening of a pre-existing medical condition/AE with onset after the start of IP and throughout the study.

    Measured: Up to Day 112

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Nov 2022
  2. Study start29 Nov 2022
  3. Primary completion5 Jun 2024
  4. Study completion9 Jul 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
174 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05619692
Sponsor's protocol ID
718-CNA-202
Status last verified
Jun 2025
First submitted
9 Nov 2022
Last updated
15 Sep 2025
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No: Data sharing will be consistent with the results submission policy of ClinicalTrials.gov.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing SAGE-718 in people with Mild Cognitive Impairment and Mild Dementia, run by Supernus Pharmaceuticals, Inc. at 39 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 39 sites in United States, Puerto Rico. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 18 Jun 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change From Baseline in the Wechsler Adult Intelligence Scale-IV (WAIS-IV) Coding Test Score (time frame: Baseline, Day 84). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05619692.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Sep 2025.

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