A Study to Evaluate the Effects of SAGE-718 in Participants With Mild Cognitive Impairment or Mild Dementia Due to Alzheimer's Disease (AD)
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ClinicalTrials.gov Identifier: NCT05619692 |
Recruitment Status :
Recruiting
First Posted : November 17, 2022
Last Update Posted : May 24, 2023
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Condition or disease | Intervention/treatment | Phase |
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Mild Cognitive Impairment Mild Dementia Alzheimer's Disease | Drug: SAGE-718 Drug: SAGE-718-matching Placebo | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 150 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Treatment |
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 |
Actual Study Start Date : | December 27, 2022 |
Estimated Primary Completion Date : | December 2024 |
Estimated Study Completion Date : | January 2025 |

Arm | Intervention/treatment |
---|---|
Experimental: SAGE-718
Participants will receive 1.2mg of SAGE-718 orally once daily for the first 6 weeks Days 1 to 42 [±2 days]), followed by 0.9 mg of SAGE-718 for the remainder of the Treatment period up to Day 84.
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Drug: SAGE-718
Softgel lipid capsules. |
Placebo Comparator: Placebo
Participants will receive placebo-matching capsule once daily orally throughout the treatment period for up to Day 84.
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Drug: SAGE-718-matching Placebo
Softgel lipid capsules. |
- Change from Baseline in the Wechsler Adult Intelligence Scale Fourth Edition-IV (WAIS-IV) Coding Test [ Time Frame: Baseline to Day 84 ]The WAIS-IV Coding Test is a valid and sensitive measure of cognitive dysfunction. Administration of the WAIS-IV Coding Test will use the traditional paper-and-pen format, in which the participant is required to identify the symbols matched to numbers using a key and write in the symbol beneath the associated number. The score will be based on the total number of codes correctly completed over a 120-second time limit.
- Percentage of Participants With At least One or More Treatment-emergent Adverse Events (TEAEs) and by Severity [ Time Frame: From the inform consent signing up to end of the study (Up to approximately Day 116) ]An AE is any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. A TEAE is defined as an AE with onset after the start of IP, or any worsening of a pre-existing medical condition/AE with onset after the start of IP and throughout the study.
- Number of Participants Who Withdraw Due to Adverse Events (AEs) [ Time Frame: From the inform consent signing up to end of the study (Up to approximately Day 116) ]

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Ages Eligible for Study: | 50 Years to 80 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
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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) at Screening.
Exclusion Criteria:
- 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
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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
- 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
- Be at risk for suicidal ideation as per Columbia-Suicide Severity Rating Scale (C-SSRS) and/or in the opinion of the investigator
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Have any of the following medical conditions:
- Any clinically significant finding on 12-lead electrocardiogram (ECG) during Screening in the opinion of the investigator
- Supine vital signs outside of the following ranges during Screening (vital sign measurements may be repeated once if initial values exceed these ranges):
i. Heart rate <50 or >100 bpm ii. Systolic blood pressure <100 or >160 mmHg iii. Diastolic blood pressure <60 or >100 mmHg
- 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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05619692
Contact: Tiffany Lago, MD | 617-733-6386 | tiffany.lago@sagerx.com |
United States, Arizona | |
Sage Investigational Site | Recruiting |
Phoenix, Arizona, United States, 85044 | |
Contact clinicaltrialsinquiry@sagerx.com | |
United States, California | |
Sage Investigational Site | Recruiting |
Lafayette, California, United States, 94549 | |
Contact clinicaltrialsinquiry@sagerx.com | |
Sage Investigational Site | Recruiting |
Long Beach, California, United States, 90806 | |
Contact clinicaltrialsinquiry@sagerx.com | |
Sage Investigational Site | Recruiting |
Redlands, California, United States, 92374 | |
Contact clinicaltrialsinquiry@sagerx.com | |
Sage Investigational Site | Recruiting |
Sherman Oaks, California, United States, 91403 | |
Contact clinicaltrialsinquiry@sagerx.com | |
United States, Florida | |
Sage Investigational Site | Recruiting |
Jacksonville, Florida, United States, 32256 | |
Contact clinicaltrialsinquiry@sagerx.com | |
Sage Investigational Site | Recruiting |
Palm Beach Gardens, Florida, United States, 33410 | |
Contact clinicaltrialsinquiry@sagerx.com | |
Sage Investigational Site | Recruiting |
Winter Park, Florida, United States, 32789 | |
Contact clinicaltrialsinquiry@sagerx.com | |
United States, Georgia | |
Sage Investigational Site | Recruiting |
Decatur, Georgia, United States, 30030 | |
Contact clinicaltrialsinquiry@sagerx.com | |
Sage Investigational Site | Recruiting |
Savannah, Georgia, United States, 31405 | |
Contact clinicaltrialsinquiry@sagerx.com | |
United States, Illinois | |
Sage Investigational Site | Recruiting |
Chicago, Illinois, United States, 60640 | |
Contact clinicaltrialsinquiry@sagerx.com | |
United States, Missouri | |
Sage Investigational Site | Recruiting |
Chesterfield, Missouri, United States, 63005 | |
Contact clinicaltrialsinquiry@sagerx.com | |
United States, Nebraska | |
Sage Investigational Site | Recruiting |
Papillion, Nebraska, United States, 68046 | |
Contact clinicaltrialsinquiry@sagerx.com | |
United States, New Jersey | |
Sage Investigational Site | Recruiting |
Toms River, New Jersey, United States, 08755 | |
Contact clinicaltrialsinquiry@sagerx.com | |
United States, New York | |
Sage Investigational Site | Recruiting |
Brooklyn, New York, United States, 11229 | |
Contact clinicaltrialsinquiry@sagerx.com | |
Sage Investigational Site | Recruiting |
Buffalo, New York, United States, 14203 | |
Contact clinicaltrialsinquiry@sagerx.com | |
Sage Investigational Site | Recruiting |
Staten Island, New York, United States, 10314 | |
Contact clinicaltrialsinquiry@sagerx.com | |
United States, North Carolina | |
Sage Investigational Site | Recruiting |
Raleigh, North Carolina, United States, 27607 | |
Contact clinicaltrialsinquiry@sagerx.com | |
United States, Pennsylvania | |
Sage Investigational Site | Recruiting |
Abington, Pennsylvania, United States, 19001 | |
Contact clinicaltrialsinquiry@sagerx.com | |
United States, Tennessee | |
Sage Investigational Site | Recruiting |
Memphis, Tennessee, United States, 38119 | |
Contact clinicaltrialsinquiry@sagerx.com | |
United States, Texas | |
Sage Investigational Site | Recruiting |
Austin, Texas, United States, 78731 | |
Contact clinicaltrialsinquiry@sagerx.com | |
Sage Investigational Site | Recruiting |
Dallas, Texas, United States, 75231 | |
Contact clinicaltrialsinquiry@sagerx.com | |
Sage Investigational Site | Recruiting |
Houston, Texas, United States, 77030 | |
Contact clinicaltrialsinquiry@sagerx.com | |
United States, Virginia | |
Sage Investigational Site | Recruiting |
Fairfax, Virginia, United States, 22031 | |
Contact clinicaltrialsinquiry@sagerx.com |
Responsible Party: | Sage Therapeutics |
ClinicalTrials.gov Identifier: | NCT05619692 |
Other Study ID Numbers: |
718-CNA-202 |
First Posted: | November 17, 2022 Key Record Dates |
Last Update Posted: | May 24, 2023 |
Last Verified: | May 2023 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Plan Description: | Data sharing will be consistent with the results submission policy of ClinicalTrials.gov. |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
SAGE-718 Cognitive dysfunction NMDA |
Alzheimer Disease Dementia Cognitive Dysfunction Brain Diseases Central Nervous System Diseases Nervous System Diseases |
Tauopathies Neurodegenerative Diseases Neurocognitive Disorders Mental Disorders Cognition Disorders |